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These were participants from the original trial, not a newly randomized cohort.","sectionIds":["dom14725-sec-0007","dom14725-sec-0012"]},"findings":{"text":"The report describes a mean regain of 11.6 percentage points of body weight in the former semaglutide arm, after 17.3% loss during treatment; mean weight remained 5.6% below baseline at week 120.","sectionIds":["dom14725-sec-0013"]},"limitations":{"text":"There was no randomized continuation arm. Analyses were exploratory, the extension selected treatment completers, and adverse events were not systematically collected. The observation cannot separate stopping medication from stopping structured lifestyle support.","sectionIds":["dom14725-sec-0007","dom14725-sec-0008","dom14725-sec-0010","dom14725-sec-0017"]},"id":"analysis-NCT03548935-35441470-v1","version":1,"sourceId":"fulltext-PMC9542252-20260920","registrySourceId":"registry-NCT03548935-20260920","reviewedAt":"2026-09-20"},{"nctId":"NCT03574597","pmid":"38796653","title":"SELECT: secondary kidney outcomes","role":"secondary-analysis","relationship":{"text":"A prespecified secondary analysis of the SELECT cardiovascular-outcomes trial, using the same randomized participants.","sectionIds":["Sec13","Sec15"]},"question":{"text":"Did semaglutide affect a five-component kidney endpoint, including kidney death, replacement therapy, sustained filtration decline and persistent macroalbuminuria?","sectionIds":["Sec17"]},"population":{"text":"SELECT randomized 17,604 adults with overweight or obesity and established cardiovascular disease, without diabetes. This publication does not add another independent study population.","sectionIds":["Sec15"]},"findings":{"text":"The composite occurred in 1.8% of semaglutide participants and 2.2% of placebo participants (hazard ratio 0.78; 95% confidence interval 0.63–0.96). The difference was driven mainly by macroalbuminuria and persistent reduction of at least 50% in estimated filtration.","sectionIds":["Sec5"]},"limitations":{"text":"Tests were not adjusted for multiple comparisons, and other component events were sparse. Creatinine-based filtration estimates can change with muscle loss; cystatin C was not measured. The composite finding does not establish improvement in every kidney outcome.","sectionIds":["Sec5","Sec13","Sec18"]},"id":"analysis-NCT03574597-38796653-v1","version":1,"sourceId":"fulltext-PMC11271413-20260920","registrySourceId":"registry-NCT03574597-20260920","reviewedAt":"2026-09-20"},{"nctId":"NCT04881760","pmid":"38858523","title":"Retatrutide: liver-fat imaging substudy","role":"substudy","relationship":{"text":"A liver-imaging substudy within the phase 2 obesity trial, restricted to participants meeting an additional liver-fat criterion.","sectionIds":["Sec13"]},"question":{"text":"How did relative liver fat measured by MRI change at week 24? Week-48 change was secondary, and several normalization thresholds were exploratory.","sectionIds":["Sec16"]},"population":{"text":"The substudy included 98 of the parent trial's 338 randomized participants. Liver-fat MRI data were available for 78.6% at week 24 and 43.9% at week 48.","sectionIds":["Sec3"]},"findings":{"text":"The paper reports larger relative MRI liver-fat reductions with retatrutide than placebo at week 24. Liver enzymes and commonly used fibrosis scores did not consistently change versus placebo.","sectionIds":["Sec5","Sec9"]},"limitations":{"text":"The analyses were not adjusted for multiple comparisons and excluded data after permanent treatment discontinuation. Missing imaging was substantial at week 48. The study did not assess liver histology, so imaging changes do not establish fibrosis reversal or clinical liver-outcome benefit.","sectionIds":["Sec3","Sec11","Sec17"]},"id":"analysis-NCT04881760-38858523-v1","version":1,"sourceId":"fulltext-PMC11271400-20260920","registrySourceId":"registry-NCT04881760-20260920","reviewedAt":"2026-09-20"},{"nctId":"NCT03323749","pmid":"39574155","title":"MMPOWER-3: exploratory genotype subgroups","role":"post-hoc-analysis","relationship":{"text":"Further exploratory analyses of MMPOWER-3 per-protocol completers, following a parent trial that missed its primary endpoints.","sectionIds":["Sec5","Sec8"]},"question":{"text":"Did changes in six-minute walking distance differ within selected genetic and clinical subgroups?","sectionIds":["Sec5"]},"population":{"text":"The highlighted subgroup combined a mitochondrial DNA replisome genotype with chronic progressive external ophthalmoplegia: 18 elamipretide and 14 placebo participants from the original trial.","sectionIds":["Sec7"]},"findings":{"text":"At week 24, that subgroup had a reported mean walking-distance increase of 37.3 metres with elamipretide versus a decrease of 8.0 metres with placebo. Fatigue did not show the same differential pattern between the broader genetic cohorts.","sectionIds":["Sec7","Sec8"]},"limitations":{"text":"These small, nested post hoc groups were selected from trial completers. The walking result is exploratory and does not turn the negative parent trial into a positive confirmatory result or establish benefit across mitochondrial diseases.","sectionIds":["Sec5","Sec8"]},"id":"analysis-NCT03323749-39574155-v1","version":1,"sourceId":"fulltext-PMC11583740-20260920","registrySourceId":"registry-NCT03323749-20260920","reviewedAt":"2026-09-20"},{"nctId":"NCT04026113","pmid":"41913506","title":"Pediatric linaclotide: neurodevelopmental subgroup","role":"post-hoc-analysis","relationship":{"text":"A descriptive post hoc subgroup analysis of the pediatric functional-constipation trial.","sectionIds":["jpn370424-sec-0110"]},"question":{"text":"How did weekly spontaneous bowel movements and tolerability compare over 12 weeks in children with recorded neurodevelopmental conditions?","sectionIds":["jpn370424-sec-0120"]},"population":{"text":"The subgroup contained 57 of 328 treated parent-trial participants: 25 received linaclotide and 32 placebo; 52 had ADHD. These are overlapping trial participants, not a separate trial.","sectionIds":["jpn370424-sec-0150"]},"findings":{"text":"Mean weekly spontaneous bowel movements increased by 2.09 with linaclotide and 0.59 with placebo. One serious fecaloma event led to discontinuation and was considered related to linaclotide by the investigator.","sectionIds":["jpn370424-sec-0160","jpn370424-sec-0180"]},"limitations":{"text":"No formal hypothesis test was planned; standardized mean differences were descriptive. The small subgroup was mainly children with ADHD, and outcome-specific sample sizes varied. These observations cannot establish equivalent effects across all neurodevelopmental conditions.","sectionIds":["jpn370424-sec-0130","jpn370424-sec-0150","jpn370424-sec-0160"]},"id":"analysis-NCT04026113-41913506-v1","version":1,"sourceId":"fulltext-PMC13342784-20260920","registrySourceId":"registry-NCT04026113-20260920","reviewedAt":"2026-09-20"},{"nctId":"NCT03574597","pmid":"38740993","title":"SELECT: weight changes through four years","role":"secondary-analysis","relationship":{"text":"A secondary report of weight and body measurements from the SELECT cardiovascular-outcomes trial, using the same randomized population.","sectionIds":["Sec13","Sec15"]},"question":{"text":"How did weight and waist measurements change during trial follow-up, including observations through week 208?","sectionIds":["Sec19"]},"population":{"text":"SELECT randomized 17,604 adults with established cardiovascular disease and overweight or obesity, without diabetes. The number contributing measured weight varied by visit; the whole cohort did not supply four-year measurements.","sectionIds":["Sec3","Sec5","Sec15"]},"findings":{"text":"At week 208, the report's in-trial weight changes averaged −10.2% with semaglutide and −1.5% with placebo. A separate analysis limited to time on treatment gave different estimates; it answers a different question.","sectionIds":["Sec5","Sec20"]},"limitations":{"text":"Missing values were imputed for treatment comparisons, and confidence intervals were not adjusted for multiple comparisons. Treatment discontinuation occurred in both arms. Body composition was not measured, so weight change alone cannot quantify fat or muscle change. Findings do not describe every population with obesity.","sectionIds":["Sec13","Sec19","Sec20"]},"id":"analysis-NCT03574597-38740993-v1","version":1,"sourceId":"fulltext-PMC11271387-20260920","registrySourceId":"registry-NCT03574597-20260920","reviewedAt":"2026-09-20"},{"nctId":"NCT04184622","pmid":"39497468","title":"SURMOUNT-1: patient-reported quality of life","role":"secondary-analysis","relationship":{"text":"A report of patient-reported outcomes from SURMOUNT-1, with treatment-group comparisons and separate post hoc analyses of associations with weight reduction.","sectionIds":["dom16046-sec-0007","dom16046-sec-0008","dom16046-sec-0010"]},"question":{"text":"How did reported health-related quality of life, including physical and psychosocial functioning, change over 72 weeks?","sectionIds":["dom16046-sec-0008","dom16046-sec-0009"]},"population":{"text":"The parent trial randomized 2,539 participants: 1,896 to tirzepatide and 643 to placebo. This report reuses that population; analyses by achieved weight reduction were restricted to tirzepatide-treated participants.","sectionIds":["dom16046-sec-0010","dom16046-sec-0012","dom16046-sec-0018"]},"findings":{"text":"The authors report greater improvement with tirzepatide than placebo in weight-related quality-of-life and health-utility scores. Associations between the amount of weight reduction and questionnaire improvement were relatively weak overall.","sectionIds":["dom16046-sec-0013","dom16046-sec-0016","dom16046-sec-0018"]},"limitations":{"text":"The analysis excluded data after treatment discontinuation, carried forward earlier observations and made no adjustment for multiple comparisons. Only about one fifth had baseline physical-function limitations, and participants with more severe depressive symptoms were excluded. Weight-loss categories were not randomized and cannot establish that weight loss caused a psychological benefit.","sectionIds":["dom16046-sec-0010","dom16046-sec-0018"]},"id":"analysis-NCT04184622-39497468-v1","version":1,"sourceId":"fulltext-PMC11701187-20260920","registrySourceId":"registry-NCT04184622-20260920","reviewedAt":"2026-09-20"},{"nctId":"NCT04184622","pmid":"41187013","title":"SURMOUNT-1: baseline physical-function subgroups","role":"post-hoc-analysis","relationship":{"text":"This reading covers only the SURMOUNT-1 portion of a post hoc paper spanning SURMOUNT-1, -3 and -4. Results pooled across those trials are not assigned to this study.","sectionIds":["oby70067-sec-0010","oby70067-sec-0013"]},"question":{"text":"Within SURMOUNT-1, how did changes in self-reported physical function at week 72 vary by baseline physical-function quartile?","sectionIds":["oby70067-sec-0012","oby70067-sec-0013"]},"population":{"text":"The SURMOUNT-1 efficacy and questionnaire comparisons selected one tirzepatide arm and placebo, with participants grouped by baseline questionnaire scores. They do not represent every original randomized treatment group.","sectionIds":["oby70067-sec-0013","oby70067-sec-0015"]},"findings":{"text":"In the SURMOUNT-1 results, participants in the lowest baseline physical-function quartile showed larger questionnaire-score improvements than those in the highest quartile. Tirzepatide exceeded placebo on the weight-specific physical-function measure in each quartile.","sectionIds":["oby70067-sec-0018"]},"limitations":{"text":"These subgroup analyses were not powered as confirmatory tests. They used self-reported function, excluded observations after treatment discontinuation and carried forward earlier observations for missing data. Questionnaire changes do not demonstrate improved muscle mass or objectively measured physical performance.","sectionIds":["oby70067-sec-0013","oby70067-sec-0022"]},"id":"analysis-NCT04184622-41187013-v1","version":1,"sourceId":"fulltext-PMC12724063-20260920","registrySourceId":"registry-NCT04184622-20260920","reviewedAt":"2026-09-20"},{"id":"analysis-NCT04184622-39800653-v1","version":1,"nctId":"NCT04184622","pmid":"39800653","sourceId":"fulltext-PMC12096058-20260920","registrySourceId":"registry-NCT04184622-20260920","reviewedAt":"2026-09-20","title":"SURMOUNT-1: a retrospective definition of weight plateau","role":"post-hoc-analysis","relationship":{"text":"This reading covers SURMOUNT-1 participants only; the paper also analyzes SURMOUNT-4. These are reused trial participants, not a new trial.","sectionIds":["cob12734-sec-0006"]},"question":{"text":"When did weight change remain below 5% in every subsequent 12-week interval? This definition does not mean weight stopped changing.","sectionIds":["cob12734-sec-0008"]},"population":{"text":"The 1,438 selected participants were adherent, achieved at least 5% weight loss, had final weight data and no later dose reduction. Post-discontinuation data were excluded.","sectionIds":["cob12734-sec-0007"]},"findings":{"text":"By week 72, approximately 88–90% met this plateau definition across baseline BMI groups. The corrected abstract identifies week 72 as the time point.","sectionIds":["article-abstract"]},"limitations":{"text":"Selection excludes many original participants. Plateau timing depends on later observations and scheduled visits; its definition has no established consensus. This exploratory analysis cannot specify an individual treatment decision.","sectionIds":["cob12734-sec-0007","cob12734-sec-0008","cob12734-sec-0016"]},"correctionAppraisals":[{"sectionId":"article-abstract","noticeSha256":"dd97db2191b9ff15c46dd699d468dd2fe62d39ba87801bcb810d88a01e465226","disposition":"corrected-source-used","affectedClaims":["findings"],"text":"The January 22, 2025 inline correction removes an erroneous percent sign from the week-72 label. This reading uses that corrected time point; the notice remains linked here."}]},{"id":"analysis-NCT01394952-41988866-v1","version":1,"nctId":"NCT01394952","pmid":"41988866","sourceId":"fulltext-PMC13084528-20260920","registrySourceId":"registry-NCT01394952-20260920","reviewedAt":"2026-09-20","title":"REWIND: exploratory neurodegeneration biomarkers","role":"post-hoc-analysis","relationship":{"text":"This post hoc biomarker analysis reuses REWIND participants; it is not a separate dementia-treatment trial.","sectionIds":["alz71391-sec-0080","alz71391-sec-0230"]},"question":{"text":"Did dulaglutide affect two-year blood biomarker changes, and did baseline biomarker groups differ in subsequent cognitive-test outcomes?","sectionIds":["alz71391-sec-0130"]},"population":{"text":"The analysis selected 7,368 participants with cognitive testing and baseline/year-two biomarker data: 3,741 assigned dulaglutide and 3,627 placebo. Individual assay denominators differ.","sectionIds":["alz71391-sec-0080","alz71391-sec-0100"]},"findings":{"text":"Overall between-group changes in NfL, p-tau217 and GFAP were not statistically significant. Favorable findings were confined to selected analyses: NfL change in the high-NfL subgroup and cognitive impairment in the high-p-tau217 subgroup.","sectionIds":["alz71391-sec-0190","alz71391-sec-0200","alz71391-sec-0210","alz71391-sec-0220"]},"limitations":{"text":"Testing was exploratory without multiplicity adjustment, with limited power for cognitive interactions. Cognitive impairment was defined by test scores, not a dementia diagnosis; subgroup findings do not establish dementia prevention.","sectionIds":["alz71391-sec-0090","alz71391-sec-0130","alz71391-sec-0230"]}},{"id":"analysis-NCT04184622-40677091-v1","version":1,"nctId":"NCT04184622","pmid":"40677091","sourceId":"fulltext-PMC12326891-20260920","registrySourceId":"registry-NCT04184622-20260920","reviewedAt":"2026-09-20","title":"SURMOUNT-1: early and later weight-response patterns","role":"post-hoc-analysis","relationship":{"text":"This descriptive post hoc analysis reuses the tirzepatide-treated SURMOUNT-1 cohort, without a placebo comparison for these response categories.","sectionIds":["dom16554-sec-0008"]},"question":{"text":"Among selected adherent participants, how did week-72 weight outcomes differ according to weight change at week 12?","sectionIds":["dom16554-sec-0008"]},"population":{"text":"The 1,545 participants received at least 75% of assigned treatment and had weights at weeks 0, 12, 24 and 72. There were 278 with less than 5% loss at week 12 and 1,267 early responders.","sectionIds":["dom16554-sec-0008","dom16554-sec-0010"]},"findings":{"text":"Of the 278 later responders, 250 (90%) reached at least 5% weight reduction by week 72. This percentage applies to the selected adherent group, not everyone who started treatment.","sectionIds":["dom16554-sec-0011","dom16554-sec-0008"]},"limitations":{"text":"Response groups were not randomized. Complete-weight and adherence requirements limit generalization; diet and activity differences were unavailable. These observations do not determine whether an individual should continue or stop treatment.","sectionIds":["dom16554-sec-0008","dom16554-sec-0013"]}}],"studies":[{"nctId":"NCT03548935","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"STEP 1: weight change without diabetes","topic":"Weight management","treatmentKind":"single","peptideSlugs":["semaglutide"],"registrySourceId":"registry-NCT03548935-20260920","treatmentContext":"Subcutaneous semaglutide versus placebo, alongside lifestyle intervention.","primaryQuestion":"Percentage weight change and the proportion losing at least 5% of baseline weight at week 68.","interpretation":"The study had two primary weight endpoints. Its results do not describe what happens after treatment is stopped.","evidenceState":"reviewed-results","anchor":"study-nct03548935","versionPath":"/studies/nct03548935/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"semaglutide","reviewVersion":1,"studyHeading":"STEP 1 weight-management trial","studySha256":"5d5ea897d0ebc882d9e3bebdddcb308270e5ee9be012e950e9e1a0011618d18b","pmid":"33567185","reviewedAt":"2026-08-18","reviewVersionReviewedAt":"2026-08-18","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/semaglutide/synthesis/versions/1/","identityKey":"registry-NCT03548935-20260920:33567185","study":{"heading":"STEP 1 weight-management trial","sourceIds":["synthesis-pubmed-33567185-v1"],"design":{"text":"A double-blind, randomized, placebo-controlled trial followed participants for 68 weeks alongside a lifestyle intervention.","sourceIds":["synthesis-pubmed-33567185-v1"]},"population":{"text":"The trial enrolled 1,961 adults with obesity, or overweight plus at least one weight-related condition, who did not have diabetes.","sourceIds":["synthesis-pubmed-33567185-v1"]},"outcomes":{"text":"Mean body-weight change at 68 weeks was -14.9% in the semaglutide group and -2.4% with placebo. Gastrointestinal events were common, and treatment discontinuation for gastrointestinal events was more frequent with semaglutide.","sourceIds":["synthesis-pubmed-33567185-v1"]},"limitations":{"text":"The sponsor-funded trial combined treatment with lifestyle intervention, excluded people with diabetes, and does not by itself establish outcomes after treatment stops.","sourceIds":["synthesis-pubmed-33567185-v1"]}}}]},{"nctId":"NCT03574597","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"SELECT: cardiovascular outcomes","topic":"Cardiovascular outcomes","treatmentKind":"single","peptideSlugs":["semaglutide"],"registrySourceId":"registry-NCT03574597-20260920","treatmentContext":"Subcutaneous semaglutide versus placebo in people with established cardiovascular disease.","primaryQuestion":"Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke; the registry observation window extended to 240 weeks.","interpretation":"The report gives a mean follow-up of 39.8 months. That observed follow-up differs from the maximum registry observation window.","evidenceState":"reviewed-results","anchor":"study-nct03574597","versionPath":"/studies/nct03574597/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"semaglutide","reviewVersion":1,"studyHeading":"SELECT cardiovascular-outcomes trial","studySha256":"32be3a2ef12e5a3805516178d4e5ea6c973185f72d368b555e532d78c7c212b5","pmid":"37952131","reviewedAt":"2026-08-18","reviewVersionReviewedAt":"2026-08-18","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/semaglutide/synthesis/versions/1/","identityKey":"registry-NCT03574597-20260920:37952131","study":{"heading":"SELECT cardiovascular-outcomes trial","sourceIds":["synthesis-pubmed-37952131-v1"],"design":{"text":"A multicenter, double-blind, randomized, placebo-controlled, event-driven superiority trial assessed a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.","sourceIds":["synthesis-pubmed-37952131-v1"]},"population":{"text":"The trial enrolled 17,604 adults age 45 or older with established cardiovascular disease and overweight or obesity, but no history of diabetes.","sourceIds":["synthesis-pubmed-37952131-v1"]},"outcomes":{"text":"A primary cardiovascular event occurred in 6.5% of the semaglutide group and 8.0% of the placebo group; the reported hazard ratio was 0.80. Permanent discontinuation because of adverse events occurred in 16.6% and 8.2%, respectively.","sourceIds":["synthesis-pubmed-37952131-v1"]},"limitations":{"text":"The sponsor-funded findings apply to people with preexisting cardiovascular disease and without diabetes; they do not answer primary prevention for lower-risk populations.","sourceIds":["synthesis-pubmed-37952131-v1"]}}}]},{"nctId":"NCT04184622","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"SURMOUNT-1: weight change without diabetes","topic":"Weight management","treatmentKind":"single","peptideSlugs":["tirzepatide"],"registrySourceId":"registry-NCT04184622-20260920","treatmentContext":"Tirzepatide versus placebo in adults with overweight or obesity, excluding diabetes.","primaryQuestion":"Percentage weight change and the proportion losing at least 5% of baseline weight at week 72.","interpretation":"The selected report concerns the 72-week weight endpoints. Later follow-up reports require their own appraisal.","evidenceState":"reviewed-results","anchor":"study-nct04184622","versionPath":"/studies/nct04184622/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"tirzepatide","reviewVersion":1,"studyHeading":"SURMOUNT-1 obesity trial","studySha256":"966c32f6ed353c6dc0a143a932ceeda578ef6707cad5098d9adc6df7365485a0","pmid":"35658024","reviewedAt":"2026-08-19","reviewVersionReviewedAt":"2026-08-19","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/tirzepatide/synthesis/versions/1/","identityKey":"registry-NCT04184622-20260920:35658024","study":{"heading":"SURMOUNT-1 obesity trial","sourceIds":["synthesis-pubmed-35658024-v1"],"design":{"text":"A double-blind, randomized, placebo-controlled Phase 3 trial assessed body-weight change over 72 weeks.","sourceIds":["synthesis-pubmed-35658024-v1"]},"population":{"text":"The trial randomized 2,539 adults with obesity, or overweight plus at least one weight-related complication, and excluded people with diabetes.","sourceIds":["synthesis-pubmed-35658024-v1"]},"outcomes":{"text":"Reported mean body-weight change at week 72 ranged from -15.0% to -20.9% across tirzepatide groups and was -3.1% with placebo. Gastrointestinal events were the most common adverse events, and discontinuation for adverse events was more frequent in the tirzepatide groups.","sourceIds":["synthesis-pubmed-35658024-v1"]},"limitations":{"text":"The sponsor-funded trial used a dose-escalation period, excluded diabetes, and does not by itself establish outcomes after treatment stops or uncommon harms over longer periods.","sourceIds":["synthesis-pubmed-35658024-v1"]}}}]},{"nctId":"NCT04881760","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Retatrutide: phase 2 obesity study","topic":"Weight management","treatmentKind":"single","peptideSlugs":["retatrutide"],"registrySourceId":"registry-NCT04881760-20260920","treatmentContext":"Retatrutide versus placebo in adults with overweight or obesity.","primaryQuestion":"Percentage change in body weight at week 24.","interpretation":"The often-cited 48-week weight results are secondary outcomes; the primary endpoint was measured at week 24.","evidenceState":"reviewed-results","anchor":"study-nct04881760","versionPath":"/studies/nct04881760/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"retatrutide","reviewVersion":2,"studyHeading":"Phase 2 obesity trial","studySha256":"ce9999a3c4d535cd60a5033baa71a7991433eb84d3332248b7b692cef029617f","pmid":"37366315","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/retatrutide/synthesis/versions/2/","identityKey":"registry-NCT04881760-20260920:37366315","study":{"heading":"Phase 2 obesity trial","sourceIds":["synthesis-pubmed-37366315-v2"],"design":{"text":"A double-blind, randomized, placebo-controlled Phase 2 trial followed participants for 48 weeks and assessed body-weight change and safety.","sourceIds":["synthesis-pubmed-37366315-v2"]},"population":{"text":"The trial enrolled 338 adults with obesity, or overweight plus at least one weight-related condition.","sourceIds":["synthesis-pubmed-37366315-v2"]},"outcomes":{"text":"At 48 weeks, reported mean body-weight change ranged from -8.7% to -24.2% across retatrutide groups, compared with -2.1% for placebo. Gastrointestinal events were the most common adverse events, and heart-rate increases peaked at 24 weeks before declining.","sourceIds":["synthesis-pubmed-37366315-v2"]},"limitations":{"text":"This was a sponsor-funded Phase 2 trial with 48-week follow-up; it was not a long-term cardiovascular-outcomes or rare-harms study.","sourceIds":["synthesis-pubmed-37366315-v2"]}}}]},{"nctId":"NCT04867785","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Retatrutide: phase 2 diabetes study","topic":"Diabetes","treatmentKind":"single","peptideSlugs":["retatrutide"],"registrySourceId":"registry-NCT04867785-20260920","treatmentContext":"Retatrutide compared with placebo and dulaglutide in adults with type 2 diabetes.","primaryQuestion":"Change in HbA1c at week 24.","interpretation":"The report distinguishes 281 randomized participants from 275 included in efficacy analyses. Weight change at week 36 was a secondary endpoint.","evidenceState":"reviewed-results","anchor":"study-nct04867785","versionPath":"/studies/nct04867785/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"retatrutide","reviewVersion":2,"studyHeading":"Phase 2 type 2 diabetes trial","studySha256":"986e2ca109a8c6935132099594bb1673afe89db7c45c3197229b4b9d7968522f","pmid":"37385280","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/retatrutide/synthesis/versions/2/","identityKey":"registry-NCT04867785-20260920:37385280","study":{"heading":"Phase 2 type 2 diabetes trial","sourceIds":["synthesis-pubmed-37385280-v2"],"design":{"text":"A randomized, double-blind, placebo- and active-comparator-controlled Phase 2 trial evaluated glycated hemoglobin at 24 weeks and body weight at 36 weeks.","sourceIds":["synthesis-pubmed-37385280-v2"]},"population":{"text":"The trial randomized 281 adults with type 2 diabetes and elevated body-mass index at 42 U.S. centers; 275 were included in efficacy analyses.","sourceIds":["synthesis-pubmed-37385280-v2"]},"outcomes":{"text":"At 24 weeks, reported glycated-hemoglobin changes ranged from -0.43 to -2.02 percentage points across retatrutide groups, compared with -0.01 for placebo and -1.41 for the active comparator. Reported body-weight change at 36 weeks ranged from -3.19% to -16.94% across retatrutide groups.","sourceIds":["synthesis-pubmed-37385280-v2"]},"limitations":{"text":"The sponsor-funded trial had 36-week follow-up, 79% completed treatment, and 84% of participants were White; those features limit conclusions about durability and generalizability.","sourceIds":["synthesis-pubmed-37385280-v2"]}}}]},{"nctId":"NCT03512262","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"ATOM: bone density in men","topic":"Bone health","treatmentKind":"single","peptideSlugs":["abaloparatide"],"registrySourceId":"registry-NCT03512262-20260920","treatmentContext":"Abaloparatide versus placebo in men with osteoporosis.","primaryQuestion":"Percentage change in lumbar-spine bone mineral density at month 12.","interpretation":"The primary outcome was bone density. The selected report does not establish a reduction in fractures in this population.","evidenceState":"reviewed-results","anchor":"study-nct03512262","versionPath":"/studies/nct03512262/versions/1/","readingNotes":[{"heading":"What the study could measure","text":"The sample-size calculation targeted a difference in bone density. Only one clinical fracture in the abaloparatide group and three in the placebo group were reported; the authors say those few events do not permit a meaningful fracture-incidence comparison.","sourceId":"fulltext-PMC10091818-20260920","sectionIds":["jbmr4719-sec-0006","jbmr4719-sec-0009","jbmr4719-sec-0012"]}],"reports":[{"peptideSlug":"abaloparatide","reviewVersion":1,"studyHeading":"ATOM: bone-density outcomes in men","studySha256":"c3ccbc2739cf52ca6982a497587b55e428d8be060d8112a1d2b06b0c3344d45f","pmid":"36190391","reviewedAt":"2026-09-14","reviewVersionReviewedAt":"2026-09-14","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/abaloparatide/synthesis/versions/1/","identityKey":"registry-NCT03512262-20260920:36190391","study":{"heading":"ATOM: bone-density outcomes in men","sourceIds":["synthesis-pubmed-36190391-v1"],"design":{"text":"A 12-month randomized placebo-controlled trial used change in lumbar-spine bone mineral density as its primary endpoint.","sourceIds":["synthesis-pubmed-36190391-v1"]},"population":{"text":"A total of 228 men with osteoporosis were randomized: 149 to abaloparatide and 79 to placebo.","sourceIds":["synthesis-pubmed-36190391-v1"]},"outcomes":{"text":"Reported lumbar-spine bone-density gains were 8.48% with abaloparatide versus 1.17% with placebo. Common reported adverse events included injection-site reactions and dizziness.","sourceIds":["synthesis-pubmed-36190391-v1"]},"limitations":{"text":"Bone density was the primary endpoint; the reported gains should not be presented as demonstrated fracture reduction. The sample and duration limit conclusions about uncommon or longer-term harms.","sourceIds":["synthesis-pubmed-36190391-v1"]}}}]},{"nctId":"NCT01657162","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"ACTIVExtend: outcomes after ACTIVE","topic":"Bone health","treatmentKind":"follow-up","peptideSlugs":["abaloparatide"],"registrySourceId":"registry-NCT01657162-20260920","treatmentContext":"Alendronate after prior abaloparatide or placebo treatment in eligible ACTIVE completers.","primaryQuestion":"New vertebral fractures measured from the parent-study baseline through the first six extension months.","interpretation":"The registry primary window ends at cumulative month 25; this later report follows the treatment sequence through month 43. Both extension groups received alendronate.","evidenceState":"reviewed-results","anchor":"study-nct01657162","versionPath":"/studies/nct01657162/versions/1/","readingNotes":[{"heading":"Who entered the extension","text":"Extension eligibility required completion and adherence in the parent trial. People who stopped treatment, withdrew, or had a treatment-related serious adverse event in ACTIVE were excluded. The extension therefore describes selected completers.","sourceId":"fulltext-PMC6097601-20260920","sectionIds":["s7"]},{"heading":"Which follow-up is being counted","text":"The published primary fracture analysis compares the original ACTIVE baseline with cumulative month 43. Separate extension-only analyses begin at the later extension baseline. Those are different observation windows, not independent replications.","sourceId":"fulltext-PMC6097601-20260920","sectionIds":["s8","s13"]}],"reports":[{"peptideSlug":"abaloparatide","reviewVersion":1,"studyHeading":"ACTIVExtend: follow-up of ACTIVE participants","studySha256":"fda9582b59734c3fd2084a19c30373539ebcef9c6d258b6055550d34502abdae","pmid":"29800372","reviewedAt":"2026-09-14","reviewVersionReviewedAt":"2026-09-14","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/abaloparatide/synthesis/versions/1/","identityKey":"registry-NCT01657162-20260920:29800372","study":{"heading":"ACTIVExtend: follow-up of ACTIVE participants","sourceIds":["synthesis-pubmed-29800372-v1"],"design":{"text":"An extension followed eligible ACTIVE completers, with both groups subsequently receiving alendronate. It did not randomly assign a new independent cohort.","sourceIds":["synthesis-pubmed-29800372-v1"]},"population":{"text":"The extension enrolled 558 women from the former abaloparatide group and 581 from the former placebo group.","sourceIds":["synthesis-pubmed-29800372-v1"]},"outcomes":{"text":"Across the integrated 43-month period, the authors reported new radiographic vertebral fractures in 0.9% of evaluable women in the abaloparatide/alendronate group versus 5.6% in the placebo/alendronate group.","sourceIds":["synthesis-pubmed-29800372-v1"]},"limitations":{"text":"The findings describe a treatment sequence among participants who entered the extension. They cannot isolate ongoing abaloparatide effects or establish outcomes after stopping all treatment.","sourceIds":["synthesis-pubmed-29800372-v1"]}}}]},{"nctId":"NCT03323749","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"MMPOWER-3: mitochondrial myopathy","topic":"Rare disease","treatmentKind":"single","peptideSlugs":["elamipretide"],"registrySourceId":"registry-NCT03323749-20260920","treatmentContext":"Elamipretide versus placebo in people with primary mitochondrial myopathy.","primaryQuestion":"Change in six-minute walking distance and symptom-assessment total fatigue score at week 24.","interpretation":"Neither primary endpoint was met. Findings in primary mitochondrial myopathy should not be substituted for evidence in Barth syndrome.","evidenceState":"reviewed-results","anchor":"study-nct03323749","versionPath":"/studies/nct03323749/versions/1/","readingNotes":[{"heading":"Overall result versus exploratory subgroup","text":"The full text reports neither primary endpoint was met in the overall population. Its genetic subgroup analyses are exploratory, and the nuclear-DNA subgroup result is identified as post hoc; it cannot replace the overall primary result.","sourceId":"fulltext-PMC10382259-20260920","sectionIds":["s1-5-1","s2-2-1","s2-2-2","s3"]},{"heading":"An abstract and full-text discrepancy","text":"The indexed abstract and the full-text primary-results section give different confidence intervals and p values for the fatigue comparison. Both describe a nonsignificant result. We retain that shared conclusion without selecting one conflicting numerical estimate as definitive.","sourceId":"fulltext-PMC10382259-20260920","sectionIds":["s2-2-1"]}],"reports":[{"peptideSlug":"elamipretide","reviewVersion":1,"studyHeading":"MMPOWER-3: primary mitochondrial myopathy","studySha256":"2de652c40b1ee4c2c3460db3932fbf57d1d3f89056ef15f51e4d2087b3d09307","pmid":"37268435","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/elamipretide/synthesis/versions/1/","identityKey":"registry-NCT03323749-20260920:37268435","study":{"heading":"MMPOWER-3: primary mitochondrial myopathy","sourceIds":["synthesis-pubmed-37268435-v1"],"design":{"text":"A randomized, blinded, placebo-controlled phase 3 trial assessed 24-week outcomes.","sourceIds":["synthesis-pubmed-37268435-v1"]},"population":{"text":"The study randomized 218 participants with genetically confirmed primary mitochondrial myopathy.","sourceIds":["synthesis-pubmed-37268435-v1"]},"outcomes":{"text":"Neither walking distance nor fatigue met the primary efficacy endpoint. Most reported adverse events were mild or moderate.","sourceIds":["synthesis-pubmed-37268435-v1"]},"limitations":{"text":"This is a different disease population from Barth syndrome. Overall null results cannot be replaced by favorable exploratory subgroup findings.","sourceIds":["synthesis-pubmed-37268435-v1"]}}}]},{"nctId":"NCT00690898","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"PRIMARYS: acromegaly and tumor volume","topic":"Endocrinology","treatmentKind":"single","peptideSlugs":["lanreotide"],"registrySourceId":"registry-NCT00690898-20260920","treatmentContext":"Open-label lanreotide treatment without a comparison group in acromegaly with pituitary macroadenoma.","primaryQuestion":"The proportion with a relevant reduction in pituitary tumor volume on MRI at week 48.","interpretation":"The report describes 90 entrants and 89 in the primary analysis; the registry lists 108 enrolled. These are source-specific counts, not an interchangeable analyzed population.","evidenceState":"reviewed-results","anchor":"study-nct00690898","versionPath":"/studies/nct00690898/versions/1/","readingNotes":[{"heading":"Why the favorable percentage was not a positive primary test","text":"The primary analysis tested whether the response proportion exceeded a prespecified threshold. Although 62.9% met the tumor-shrinkage definition, the primary confidence interval did not clear that threshold. Sensitivity analyses used other readers and do not replace the primary analysis.","sourceId":"fulltext-PMC4009579-20260920","sectionIds":["sec14","sec18"]},{"heading":"Completion and adverse-event withdrawals","text":"The full text reports 90 treated participants and 64 completers. Five participants withdrew with treatment-emergent adverse events; three events were considered treatment related. Absence of withdrawal for gastrointestinal intolerance is narrower than absence of adverse events.","sourceId":"fulltext-PMC4009579-20260920","sectionIds":["sec16"]}],"reports":[{"peptideSlug":"lanreotide","reviewVersion":1,"studyHeading":"PRIMARYS: acromegaly","studySha256":"f3877a4f23a1c6ea964c820785974f76cfe8bc573d45a1aed0c3b0ab2af42a14","pmid":"24423301","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/lanreotide/synthesis/versions/1/","identityKey":"registry-NCT00690898-20260920:24423301","study":{"heading":"PRIMARYS: acromegaly","sourceIds":["synthesis-pubmed-24423301-v1"],"design":{"text":"48-week open-label, single-arm study with centrally assessed tumor volume.","sourceIds":["synthesis-pubmed-24423301-v1"]},"population":{"text":"90 treatment-naïve people with acromegaly and growth-hormone-secreting macroadenomas entered; 64 completed.","sourceIds":["synthesis-pubmed-24423301-v1"]},"outcomes":{"text":"The primary analysis found at least 20% tumor-volume reduction in 62.9% of 89 participants, but the prespecified null hypothesis was not rejected. Hormonal and symptom measures also improved.","sourceIds":["synthesis-pubmed-24423301-v1"]},"limitations":{"text":"No control group, attrition and differences between primary and sensitivity analyses limit causal interpretation. No gastrointestinal-intolerance withdrawals does not mean no adverse events.","sourceIds":["synthesis-pubmed-24423301-v1"]}}}]},{"nctId":"NCT00353496","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"CLARINET: neuroendocrine tumor progression","topic":"Oncology","treatmentKind":"single","peptideSlugs":["lanreotide"],"registrySourceId":"registry-NCT00353496-20260920","treatmentContext":"Lanreotide versus placebo in people with nonfunctioning enteropancreatic neuroendocrine tumors.","primaryQuestion":"Time to tumor progression or death, with assessments scheduled through week 96.","interpretation":"The report describes 204 randomized participants; the registry lists 264 enrolled. Improved progression-free survival in this report did not demonstrate improved overall survival.","evidenceState":"reviewed-results","anchor":"study-nct00353496","versionPath":"/studies/nct00353496/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"lanreotide","reviewVersion":1,"studyHeading":"CLARINET: neuroendocrine tumors","studySha256":"c3caffb901d13f1640e6e059be85a259cec7574e869717ab53b029dd79776574","pmid":"25014687","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/lanreotide/synthesis/versions/1/","identityKey":"registry-NCT00353496-20260920:25014687","study":{"heading":"CLARINET: neuroendocrine tumors","sourceIds":["synthesis-pubmed-25014687-v1"],"design":{"text":"Randomized, double-blind, placebo-controlled trial over 96 weeks.","sourceIds":["synthesis-pubmed-25014687-v1"]},"population":{"text":"204 people with advanced nonfunctioning, somatostatin-receptor-positive grade 1 or 2 neuroendocrine tumors; most had stable disease before enrollment.","sourceIds":["synthesis-pubmed-25014687-v1"]},"outcomes":{"text":"The hazard ratio for progression or death was 0.47 (95% CI 0.30–0.73). Overall survival and quality of life did not differ significantly. Treatment-related diarrhea occurred in 26% versus 9%.","sourceIds":["synthesis-pubmed-25014687-v1"]},"limitations":{"text":"The selected tumor grades, receptor status and largely stable baseline disease limit generalization. Progression-free survival is distinct from longer overall survival.","sourceIds":["synthesis-pubmed-25014687-v1"]}}}]},{"nctId":"NCT04962503","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Afamelanotide: early stroke feasibility","topic":"Neurology","treatmentKind":"single","peptideSlugs":["afamelanotide"],"registrySourceId":"registry-NCT04962503-20260920","treatmentContext":"Open-label afamelanotide in six patients with acute ischemic stroke who could not receive the specified revascularization treatments.","primaryQuestion":"Change in infarct volume from day 0 to days 3 and 9.","interpretation":"The registry lists imaging as the primary outcome; the article emphasizes feasibility and safety. Six uncontrolled observations cannot establish treatment efficacy or safety.","evidenceState":"reviewed-results","anchor":"study-nct04962503","versionPath":"/studies/nct04962503/versions/1/","readingNotes":[{"heading":"Outcome emphasis differs between sources","text":"The article methods identify adverse-event monitoring through day 42 as the primary outcome and imaging as secondary. The retrieved registry lists infarct-volume change as primary. This is a source discrepancy, not proof of why the designation changed.","sourceId":"fulltext-PMC10373257-20260920","sectionIds":["Sec6"]},{"heading":"What uncontrolled recovery can show","text":"The study was open label and nonrandomized. The authors acknowledge the small sample and that neurological improvement could reflect natural recovery. A larger randomized comparison is needed to attribute recovery to treatment.","sourceId":"fulltext-PMC10373257-20260920","sectionIds":["Sec3","Sec11"]}],"reports":[{"peptideSlug":"afamelanotide","reviewVersion":1,"studyHeading":"Acute stroke: early feasibility study","studySha256":"4c64d42c380e4ff9d3fa53ef9585603abc88247506839103f6ff77d455ae44dc","pmid":"37496004","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/afamelanotide/synthesis/versions/1/","identityKey":"registry-NCT04962503-20260920:37496004","study":{"heading":"Acute stroke: early feasibility study","sourceIds":["synthesis-pubmed-37496004-v1"],"design":{"text":"An open-label Phase 2a study assessed safety and exploratory recovery measures without a control group.","sourceIds":["synthesis-pubmed-37496004-v1"]},"population":{"text":"Six patients with acute ischemic stroke who were ineligible for revascularization therapies were enrolled.","sourceIds":["synthesis-pubmed-37496004-v1"]},"outcomes":{"text":"The surviving patients showed neurological improvement. One patient died after a recurrent stroke, which investigators assessed as unrelated to the study drug.","sourceIds":["synthesis-pubmed-37496004-v1"]},"limitations":{"text":"Six uncontrolled observations cannot distinguish drug effects from natural recovery or establish safety. The authors called for randomized studies.","sourceIds":["synthesis-pubmed-37496004-v1"]}}}]},{"nctId":"NCT04478708","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"AMG 133: first human study","topic":"Weight management","treatmentKind":"single","peptideSlugs":["maridebart-cafraglutide"],"registrySourceId":"registry-NCT04478708-20260920","treatmentContext":"Maridebart cafraglutide, also called AMG 133, versus placebo in an ascending-dose study in people with obesity.","primaryQuestion":"The number of participants with treatment-emergent adverse events, with observation windows varying by study part.","interpretation":"The paper contains both animal experiments and human observations. Only the human study belongs to this trial card; weight change was not the registered primary safety endpoint.","evidenceState":"reviewed-results","anchor":"study-nct04478708","versionPath":"/studies/nct04478708/versions/1/","readingNotes":[{"heading":"Which participants are in this report","text":"The full text describes a reported dataset of 75 participants within a registered study enrolling 110. Additional bioavailability, digital-tool and titration cohorts were outside that dataset. The registry total should not be used as the denominator for every published result.","sourceId":"fulltext-PMC10896721-20260920","sectionIds":["Sec24"]},{"heading":"Exploratory weight findings","text":"Safety and tolerability were primary; body weight was exploratory. The sample size followed early-phase conventions rather than a formal efficacy calculation, and the paper describes post hoc tests. This context matters when interpreting its weight-loss signal.","sourceId":"fulltext-PMC10896721-20260920","sectionIds":["Sec6","Sec25","Sec27"]}],"reports":[{"peptideSlug":"maridebart-cafraglutide","reviewVersion":1,"studyHeading":"Early translational and human program","studySha256":"d4ff14d53e66688fedf60e4d633e6e2f601b09e9ab025dcb725ca10b4d1fe374","pmid":"38316982","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/maridebart-cafraglutide/synthesis/versions/1/","identityKey":"registry-NCT04478708-20260920:38316982","study":{"heading":"Early translational and human program","sourceIds":["synthesis-pubmed-38316982-v1"],"design":{"text":"The publication combines preclinical experiments with an early randomized clinical trial.","sourceIds":["synthesis-pubmed-38316982-v1"]},"population":{"text":"The human trial enrolled people with obesity; animal findings in the same report are not human outcomes.","sourceIds":["synthesis-pubmed-38316982-v1"]},"outcomes":{"text":"The authors reported weight reductions in the early human program alongside pharmacologic and preclinical findings.","sourceIds":["synthesis-pubmed-38316982-v1"]},"limitations":{"text":"The abstract does not support a complete participant-flow or harms appraisal. Early exploratory findings cannot establish durable clinical benefit, and the conjugate is not interchangeable with other peptides.","sourceIds":["synthesis-pubmed-38316982-v1"]}}}]},{"nctId":"NCT05292911","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Pemvidutide: MASLD extension","topic":"Liver disease","treatmentKind":"follow-up","peptideSlugs":["pemvidutide"],"registrySourceId":"registry-NCT05292911-20260920","treatmentContext":"Continued pemvidutide or placebo in eligible completers of a preceding 12-week MASLD trial.","primaryQuestion":"The number of participants with treatment-emergent adverse events through day 110.","interpretation":"The registry primary outcome concerns adverse events; the publication calls liver-fat change its primary efficacy outcome. This is an extension cohort, and MRI liver fat is not a biopsy-based fibrosis outcome.","evidenceState":"reviewed-results","anchor":"study-nct05292911","versionPath":"/studies/nct05292911/versions/1/","readingNotes":[{"heading":"How the extension population was selected","text":"Of 94 people treated in the parent study, 83 completed treatment, 66 consented to continue, and 64 entered the extension. Participants with more advanced liver disease were excluded, limiting extrapolation to that population.","sourceId":"fulltext-PMC12529369-20260920","sectionIds":["sec2.1","sec3.1","sec4"]},{"heading":"What the measurements can establish","text":"The paper describes imaging and blood-marker outcomes. Its discussion says the suggested tissue-level improvements require confirmation in a biopsy-driven trial; this reading does not convert liver-fat changes into proven fibrosis improvement.","sourceId":"fulltext-PMC12529369-20260920","sectionIds":["sec2.3","sec4"]}],"reports":[{"peptideSlug":"pemvidutide","reviewVersion":1,"studyHeading":"MASLD extension","studySha256":"12959ad5573c24093e2fdc50fd239c67107d3c0009f60aa0698e2b8e9e33a11f","pmid":"41113119","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/pemvidutide/synthesis/versions/1/","identityKey":"registry-NCT05292911-20260920:41113119","study":{"heading":"MASLD extension","sourceIds":["synthesis-pubmed-41113119-v1"],"design":{"text":"Double-blind extension of a preceding randomized trial; NCT05292911.","sourceIds":["synthesis-pubmed-41113119-v1"]},"population":{"text":"64 participants from the earlier 94-participant study continued; this is not a new independently randomized cohort.","sourceIds":["synthesis-pubmed-41113119-v1"]},"outcomes":{"text":"At 24 weeks, reported relative liver-fat reductions were 56.3%, 75.2% and 76.4% in active groups versus 14.0% with placebo.","sourceIds":["synthesis-pubmed-41113119-v1"]},"limitations":{"text":"Selective extension participation can bias interpretation. MRI liver fat is not the same as histologic fibrosis improvement or patient-important liver outcomes.","sourceIds":["synthesis-pubmed-41113119-v1"]}}}]},{"nctId":"NCT01179048","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"LEADER: cardiovascular outcomes","topic":"Cardiovascular outcomes","treatmentKind":"single","peptideSlugs":["liraglutide"],"registrySourceId":"registry-NCT01179048-20260920","treatmentContext":"Liraglutide versus placebo added to standard care in people with type 2 diabetes and high cardiovascular risk.","primaryQuestion":"Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke.","interpretation":"The reported median follow-up was 3.8 years. The study population had type 2 diabetes and high cardiovascular risk; it does not establish the same result in lower-risk populations.","evidenceState":"reviewed-results","anchor":"study-nct01179048","versionPath":"/studies/nct01179048/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"liraglutide","reviewVersion":1,"studyHeading":"LEADER cardiovascular-outcomes trial","studySha256":"4657b6a983eb07857878b2629b4e5c0575e891db8a61caa428c2c3b212d10d9a","pmid":"27295427","reviewedAt":"2026-08-19","reviewVersionReviewedAt":"2026-08-19","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/liraglutide/synthesis/versions/1/","identityKey":"registry-NCT01179048-20260920:27295427","study":{"heading":"LEADER cardiovascular-outcomes trial","sourceIds":["synthesis-pubmed-27295427-v1"],"design":{"text":"A double-blind, randomized, placebo-controlled cardiovascular-outcomes trial followed participants for a median of 3.8 years.","sourceIds":["synthesis-pubmed-27295427-v1"]},"population":{"text":"The trial randomized 9,340 adults with type 2 diabetes and high cardiovascular risk in addition to standard care.","sourceIds":["synthesis-pubmed-27295427-v1"]},"outcomes":{"text":"The primary composite cardiovascular outcome occurred in 13.0% of the liraglutide group and 14.9% of the placebo group, with a reported hazard ratio of 0.87. Gastrointestinal events were the most common events leading to discontinuation.","sourceIds":["synthesis-pubmed-27295427-v1"]},"limitations":{"text":"The sponsor-funded findings apply to a high-cardiovascular-risk type 2 diabetes population receiving standard care and do not establish the same effect in lower-risk populations.","sourceIds":["synthesis-pubmed-27295427-v1"]}}}]},{"nctId":"NCT01144338","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"EXSCEL: cardiovascular safety and efficacy","topic":"Cardiovascular outcomes","treatmentKind":"single","peptideSlugs":["exenatide"],"registrySourceId":"registry-NCT01144338-20260920","treatmentContext":"Extended-release exenatide versus placebo alongside usual care in people with type 2 diabetes.","primaryQuestion":"Time to the first major cardiovascular event, tested for both safety noninferiority and efficacy superiority.","interpretation":"The safety noninferiority criterion was met, but the superiority criterion for reducing cardiovascular events was not. Those are different questions.","evidenceState":"reviewed-results","anchor":"study-nct01144338","versionPath":"/studies/nct01144338/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"exenatide","reviewVersion":1,"studyHeading":"EXSCEL cardiovascular-outcomes trial","studySha256":"7b995df5dd6eab664425600ab933d7a70be828d307f7363871f6d63d4d26e58e","pmid":"28910237","reviewedAt":"2026-08-19","reviewVersionReviewedAt":"2026-08-19","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/exenatide/synthesis/versions/1/","identityKey":"registry-NCT01144338-20260920:28910237","study":{"heading":"EXSCEL cardiovascular-outcomes trial","sourceIds":["synthesis-pubmed-28910237-v1"],"design":{"text":"A sponsor-funded randomized placebo-controlled cardiovascular-outcomes trial followed participants for a median of 3.2 years alongside usual care.","sourceIds":["synthesis-pubmed-28910237-v1"]},"population":{"text":"The trial randomized 14,752 adults with type 2 diabetes; 73.1% had previous cardiovascular disease.","sourceIds":["synthesis-pubmed-28910237-v1"]},"outcomes":{"text":"The primary cardiovascular outcome occurred in 11.4% of the exenatide group and 12.2% of the placebo group. The comparison met noninferiority for safety but not superiority for efficacy.","sourceIds":["synthesis-pubmed-28910237-v1"]},"limitations":{"text":"The pragmatic trial included participants with and without prior cardiovascular disease, and its borderline superiority result should not be reframed as proof of cardiovascular benefit.","sourceIds":["synthesis-pubmed-28910237-v1"]}}}]},{"nctId":"NCT01394952","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"REWIND: cardiovascular outcomes","topic":"Cardiovascular outcomes","treatmentKind":"single","peptideSlugs":["dulaglutide"],"registrySourceId":"registry-NCT01394952-20260920","treatmentContext":"Dulaglutide versus placebo in people with type 2 diabetes and cardiovascular disease or risk factors.","primaryQuestion":"Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke.","interpretation":"The reported median follow-up was 5.4 years. The composite result does not establish benefit for every component, and all-cause mortality did not differ significantly.","evidenceState":"reviewed-results","anchor":"study-nct01394952","versionPath":"/studies/nct01394952/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"dulaglutide","reviewVersion":1,"studyHeading":"REWIND: cardiovascular outcomes","studySha256":"6c12501b39e471fc8cfd5c4c9b0c57fce9b6d1206d75480fb2ba6b8f07a9e7b7","pmid":"31189511","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/dulaglutide/synthesis/versions/1/","identityKey":"registry-NCT01394952-20260920:31189511","study":{"heading":"REWIND: cardiovascular outcomes","sourceIds":["synthesis-pubmed-31189511-v1"],"design":{"text":"A blinded randomized placebo-controlled trial followed participants for a median of 5.4 years.","sourceIds":["synthesis-pubmed-31189511-v1"]},"population":{"text":"The trial enrolled 9,901 adults aged at least 50 with type 2 diabetes and cardiovascular disease or risk factors.","sourceIds":["synthesis-pubmed-31189511-v1"]},"outcomes":{"text":"The primary cardiovascular composite occurred in 12.0% with dulaglutide versus 13.4% with placebo (hazard ratio 0.88; 95% CI 0.79–0.99). Gastrointestinal adverse events were more frequent with dulaglutide.","sourceIds":["synthesis-pubmed-31189511-v1"]},"limitations":{"text":"The composite combines different outcomes and does not imply improvement in every component. All-cause mortality was not significantly different; these results do not establish effects in people without type 2 diabetes.","sourceIds":["synthesis-pubmed-31189511-v1"]}}}]},{"nctId":"NCT01147250","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"ELIXA: outcomes after an acute coronary event","topic":"Cardiovascular outcomes","treatmentKind":"single","peptideSlugs":["lixisenatide"],"registrySourceId":"registry-NCT01147250-20260920","treatmentContext":"Lixisenatide versus placebo added to usual care after a recent acute coronary event in people with type 2 diabetes.","primaryQuestion":"Time to cardiovascular death, nonfatal heart attack, nonfatal stroke or hospitalization for unstable angina.","interpretation":"The trial met its noninferiority criterion but did not show superiority. Its cardiovascular composite includes unstable-angina hospitalization, unlike some other trials in this collection.","evidenceState":"reviewed-results","anchor":"study-nct01147250","versionPath":"/studies/nct01147250/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"lixisenatide","reviewVersion":1,"studyHeading":"ELIXA: cardiovascular outcomes","studySha256":"489a452ff608585bb02cc8e69cc379d5a863039abc58e0f3f34fe37bcb5d8d1d","pmid":"26630143","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/lixisenatide/synthesis/versions/1/","identityKey":"registry-NCT01147250-20260920:26630143","study":{"heading":"ELIXA: cardiovascular outcomes","sourceIds":["synthesis-pubmed-26630143-v1"],"design":{"text":"Randomized placebo-controlled trial added lixisenatide or placebo to usual care.","sourceIds":["synthesis-pubmed-26630143-v1"]},"population":{"text":"6,068 people with type 2 diabetes and a recent acute coronary event were followed for a median of 25 months.","sourceIds":["synthesis-pubmed-26630143-v1"]},"outcomes":{"text":"The primary cardiovascular composite occurred in 13.4% versus 13.2%; hazard ratio 1.02 (95% CI 0.89–1.17). Noninferiority was met, superiority was not. Serious adverse events were not more frequent with lixisenatide.","sourceIds":["synthesis-pubmed-26630143-v1"]},"limitations":{"text":"The result is a cardiovascular safety comparison in a high-risk population, not evidence of cardiovascular benefit or the entire glycemic-efficacy program.","sourceIds":["synthesis-pubmed-26630143-v1"]}}}]},{"nctId":"NCT03439943","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"LIXIPARK: early Parkinson disease","topic":"Neurology","treatmentKind":"single","peptideSlugs":["lixisenatide"],"registrySourceId":"registry-NCT03439943-20260920","treatmentContext":"Lixisenatide versus placebo alongside stable treatment for Parkinson symptoms.","primaryQuestion":"Change in the MDS-UPDRS part III motor score at month 12.","interpretation":"The primary assessment was performed while participants were taking their Parkinson medication. The two-month washout assessment is a different time point and does not establish durable disease modification.","evidenceState":"reviewed-results","anchor":"study-nct03439943","versionPath":"/studies/nct03439943/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"lixisenatide","reviewVersion":1,"studyHeading":"LIXIPARK: exploratory Parkinson trial","studySha256":"81a57b51b8323060651f2731357fe3816b168b433670dcdb7214cbb212fc16da","pmid":"38598572","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/lixisenatide/synthesis/versions/1/","identityKey":"registry-NCT03439943-20260920:38598572","study":{"heading":"LIXIPARK: exploratory Parkinson trial","sourceIds":["synthesis-pubmed-38598572-v1"],"design":{"text":"Randomized, double-blind, placebo-controlled phase 2 trial with 12 months of treatment and a two-month washout.","sourceIds":["synthesis-pubmed-38598572-v1"]},"population":{"text":"156 people with early Parkinson disease were randomized while receiving stable symptomatic therapy.","sourceIds":["synthesis-pubmed-38598572-v1"]},"outcomes":{"text":"The between-group difference in motor-score change at 12 months was 3.08 points favoring lixisenatide. Nausea occurred in 46% and vomiting in 13% of active-group participants.","sourceIds":["synthesis-pubmed-38598572-v1"]},"limitations":{"text":"The primary assessment was in the on-medication state. A small phase 2 study cannot establish disease modification, long-term benefit or safety; larger trials are required.","sourceIds":["synthesis-pubmed-38598572-v1"]}}}]},{"nctId":"NCT05394519","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"REDEFINE 2: combination treatment with diabetes","topic":"Weight management","treatmentKind":"combination","peptideSlugs":["cagrilintide","semaglutide"],"registrySourceId":"registry-NCT05394519-20260920","treatmentContext":"Cagrilintide plus semaglutide versus placebo, with lifestyle intervention, in adults with type 2 diabetes and excess body weight.","primaryQuestion":"Percentage weight change and the proportion losing at least 5% of baseline weight at week 68.","interpretation":"These are combination-treatment results. The paper identifies a treatment-policy analysis; its estimates should not be mixed with a different estimand without checking the analysis definition.","evidenceState":"reviewed-results","anchor":"study-nct05394519","versionPath":"/studies/nct05394519/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"cagrilintide","reviewVersion":3,"studyHeading":"REDEFINE 2: combination treatment with diabetes","studySha256":"af1e4dbfb885c542ca4b26f21deef71326458b7521a9dbbcb30d01695f615d47","pmid":"40544432","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/cagrilintide/synthesis/versions/3/","identityKey":"registry-NCT05394519-20260920:40544432","study":{"heading":"REDEFINE 2: combination treatment with diabetes","sourceIds":["synthesis-pubmed-40544432-v3"],"design":{"text":"A blinded randomized placebo-controlled phase 3a trial assessed weight endpoints at 68 weeks under NCT05394519.","sourceIds":["synthesis-pubmed-40544432-v3"]},"population":{"text":"The study randomized 1,206 adults with type 2 diabetes and overweight or obesity.","sourceIds":["synthesis-pubmed-40544432-v3"]},"outcomes":{"text":"The treatment-policy analysis reported mean weight changes of −13.7% with cagrilintide-semaglutide versus −3.4% with placebo. Gastrointestinal adverse events occurred in 72.5% and 34.4%, respectively.","sourceIds":["synthesis-pubmed-40544432-v3"]},"limitations":{"text":"This comparison evaluates the combination against placebo, not either component alone. Weight and glycemic outcomes do not establish prevention of long-term complications.","sourceIds":["synthesis-pubmed-40544432-v3"]}}}]},{"nctId":"NCT05567796","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"REDEFINE 1: combination treatment without diabetes","topic":"Weight management","treatmentKind":"combination","peptideSlugs":["cagrilintide","semaglutide"],"registrySourceId":"registry-NCT05567796-20260920","treatmentContext":"Cagrilintide plus semaglutide, either component alone, or placebo alongside lifestyle intervention.","primaryQuestion":"Percentage weight change and the proportion losing at least 5% of baseline weight at week 68, comparing the combination with placebo.","interpretation":"The registry still lists estimated enrollment of 3,400; the report describes 3,417 randomized participants. Its headline combination-versus-placebo result is not a cagrilintide-alone result.","evidenceState":"reviewed-results","anchor":"study-nct05567796","versionPath":"/studies/nct05567796/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"cagrilintide","reviewVersion":3,"studyHeading":"REDEFINE 1: combination treatment without diabetes","studySha256":"096e9a1a8482c6fd4e247d93d3a979906a7e410cdea48c99485bd7a51b24fed1","pmid":"40544433","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/cagrilintide/synthesis/versions/3/","identityKey":"registry-NCT05567796-20260920:40544433","study":{"heading":"REDEFINE 1: combination treatment without diabetes","sourceIds":["synthesis-pubmed-40544433-v3"],"design":{"text":"A blinded randomized phase 3a trial compared combination treatment, either component alone and placebo over 68 weeks under NCT05567796.","sourceIds":["synthesis-pubmed-40544433-v3"]},"population":{"text":"The trial randomized 3,417 adults with overweight or obesity without diabetes across four groups.","sourceIds":["synthesis-pubmed-40544433-v3"]},"outcomes":{"text":"The treatment-policy analysis reported mean weight changes of −20.4% with cagrilintide-semaglutide versus −3.0% with placebo. Gastrointestinal adverse events occurred in 79.6% and 39.9%, respectively.","sourceIds":["synthesis-pubmed-40544433-v3"]},"limitations":{"text":"These estimates concern the combination and cannot be attributed to cagrilintide alone. The abstract does not give the component-alone outcome estimates needed to assess each component’s contribution.","sourceIds":["synthesis-pubmed-40544433-v3"]}}}]},{"nctId":"NCT06323161","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"REIMAGINE 3: combination added to basal insulin","topic":"Diabetes","treatmentKind":"combination","peptideSlugs":["cagrilintide","semaglutide"],"registrySourceId":"registry-NCT06323161-20260920","treatmentContext":"Cagrilintide plus semaglutide versus placebo added to basal insulin, with or without metformin.","primaryQuestion":"Change in HbA1c at week 40.","interpretation":"This report uses an efficacy estimand and a population already receiving basal insulin. Its estimates answer a different question from the REDEFINE weight-management trials.","evidenceState":"reviewed-results","anchor":"study-nct06323161","versionPath":"/studies/nct06323161/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"cagrilintide","reviewVersion":3,"studyHeading":"REIMAGINE 3: combination treatment alongside basal insulin","studySha256":"0fd0970795b8bd777673dba0427373575d9a54b007c2aaa8085c7884ffa15883","pmid":"42251856","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/cagrilintide/synthesis/versions/3/","identityKey":"registry-NCT06323161-20260920:42251856","study":{"heading":"REIMAGINE 3: combination treatment alongside basal insulin","sourceIds":["synthesis-pubmed-42251856-v3"],"design":{"text":"A blinded randomized placebo-controlled phase 3a trial assessed 40-week HbA1c change under NCT06323161.","sourceIds":["synthesis-pubmed-42251856-v3"]},"population":{"text":"The study randomized 274 adults with type 2 diabetes receiving basal insulin, with or without metformin.","sourceIds":["synthesis-pubmed-42251856-v3"]},"outcomes":{"text":"Under the efficacy analysis, HbA1c fell by 2.33 and 2.10 percentage points in the combination groups versus 0.66 with placebo. Gastrointestinal events were common; no severe hypoglycemia was reported.","sourceIds":["synthesis-pubmed-42251856-v3"]},"limitations":{"text":"The report recorded one death due to malignancy in an active group, considered unrelated to treatment. Absence of severe hypoglycemia in this study does not establish absence of risk, and the findings are not an individualized treatment recommendation.","sourceIds":["synthesis-pubmed-42251856-v3"]}}}]},{"nctId":"NCT06323174","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"REIMAGINE 1: combination in early diabetes","topic":"Diabetes","treatmentKind":"combination","peptideSlugs":["cagrilintide","semaglutide"],"registrySourceId":"registry-NCT06323174-20260920","treatmentContext":"Cagrilintide plus semaglutide versus placebo in adults whose type 2 diabetes was inadequately controlled with diet and exercise.","primaryQuestion":"Change in HbA1c at week 40.","interpretation":"The primary outcome concerns blood glucose; weight change was secondary. These efficacy-estimand results should not be ranked directly against treatment-policy estimates from other populations.","evidenceState":"reviewed-results","anchor":"study-nct06323174","versionPath":"/studies/nct06323174/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"cagrilintide","reviewVersion":3,"studyHeading":"REIMAGINE 1: early type 2 diabetes","studySha256":"b98bb44c14b5ddc5f8034b2a76e69d4bf6f1223321834df8214c61f5d53c6cf4","pmid":"42251860","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/cagrilintide/synthesis/versions/3/","identityKey":"registry-NCT06323174-20260920:42251860","study":{"heading":"REIMAGINE 1: early type 2 diabetes","sourceIds":["synthesis-pubmed-42251860-v3"],"design":{"text":"A blinded randomized placebo-controlled phase 3a trial assessed 40-week HbA1c change under NCT06323174.","sourceIds":["synthesis-pubmed-42251860-v3"]},"population":{"text":"The trial randomized 189 adults whose type 2 diabetes was inadequately controlled with diet and exercise.","sourceIds":["synthesis-pubmed-42251860-v3"]},"outcomes":{"text":"Under the efficacy analysis, HbA1c fell by 1.8 and 1.5 percentage points in the combination groups versus 0.1 with placebo. Adverse events occurred in 79%, 75% and 66%, respectively, and were predominantly mild or moderate gastrointestinal events.","sourceIds":["synthesis-pubmed-42251860-v3"]},"limitations":{"text":"The efficacy estimand differs from the treatment-policy analyses in the REDEFINE reports. These populations, endpoints and analyses should not be combined into a simple treatment ranking.","sourceIds":["synthesis-pubmed-42251860-v3"]}}}]},{"nctId":"NCT05369390","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Oral amycretin: first human study","topic":"Weight management","treatmentKind":"single","peptideSlugs":["amycretin"],"registrySourceId":"registry-NCT05369390-20260920","treatmentContext":"Oral amycretin versus placebo in several early ascending-exposure cohorts.","primaryQuestion":"The number of treatment-emergent adverse events, with follow-up windows of 22, 31 or 105 days depending on study part.","interpretation":"The 144 participants were spread across different study parts. Weight-related outcomes were exploratory, and the parts did not all share the same treatment duration.","evidenceState":"reviewed-results","anchor":"study-nct05369390","versionPath":"/studies/nct05369390/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"amycretin","reviewVersion":2,"studyHeading":"Oral amycretin: first-in-human study","studySha256":"6c7caf04c2624551df7b3b3de130512379bdd6171b1e38d8288d80268b24abd6","pmid":"40550229","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/amycretin/synthesis/versions/2/","identityKey":"registry-NCT05369390-20260920:40550229","study":{"heading":"Oral amycretin: first-in-human study","sourceIds":["synthesis-pubmed-40550229-v2"],"design":{"text":"A blinded randomized placebo-controlled phase 1 study contained several escalating-exposure parts.","sourceIds":["synthesis-pubmed-40550229-v2"]},"population":{"text":"The study enrolled 144 adults with overweight or obesity across its parts.","sourceIds":["synthesis-pubmed-40550229-v2"]},"outcomes":{"text":"Treatment-emergent adverse events were reported in 89 participants and were mild or moderate; gastrointestinal events were common.","sourceIds":["synthesis-pubmed-40550229-v2"]},"limitations":{"text":"Safety was the primary endpoint; weight-related measures were exploratory. Small cohorts and short follow-up do not establish long-term clinical benefit or safety.","sourceIds":["synthesis-pubmed-40550229-v2"]}}}]},{"nctId":"NCT06064006","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Subcutaneous amycretin: early human study","topic":"Weight management","treatmentKind":"single","peptideSlugs":["amycretin"],"registrySourceId":"registry-NCT06064006-20260920","treatmentContext":"Subcutaneous amycretin versus placebo across several cohorts with different treatment durations.","primaryQuestion":"The number of treatment-emergent adverse events, assessed through the end of each study part.","interpretation":"Weight findings came from small cohorts followed for different lengths of time. The authors reported substantial withdrawal, which limits interpretation of the estimates.","evidenceState":"reviewed-results","anchor":"study-nct06064006","versionPath":"/studies/nct06064006/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"amycretin","reviewVersion":2,"studyHeading":"Subcutaneous amycretin: phase 1b/2a study","studySha256":"8690f3faee5193d0995a9e0ce4667640de1cb2ed89895364c1de36ff3bd3b4a7","pmid":"40550231","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/amycretin/synthesis/versions/2/","identityKey":"registry-NCT06064006-20260920:40550231","study":{"heading":"Subcutaneous amycretin: phase 1b/2a study","sourceIds":["synthesis-pubmed-40550231-v2"],"design":{"text":"A randomized placebo-controlled multipart study assessed safety and secondary body-weight changes over up to 36 weeks.","sourceIds":["synthesis-pubmed-40550231-v2"]},"population":{"text":"The study randomized 125 adults with overweight or obesity at one research center.","sourceIds":["synthesis-pubmed-40550231-v2"]},"outcomes":{"text":"Estimated weight reductions were greater with amycretin. Gastrointestinal events were common, and the authors reported many study withdrawals.","sourceIds":["synthesis-pubmed-40550231-v2"]},"limitations":{"text":"Primary endpoints concerned adverse events. Small cohorts, different observation lengths and substantial attrition limit comparisons and interpretation of weight estimates.","sourceIds":["synthesis-pubmed-40550231-v2"]}}}]},{"nctId":"NCT06542874","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Zenagamtide: oral and subcutaneous diabetes cohorts","topic":"Diabetes","treatmentKind":"single","peptideSlugs":["amycretin"],"registrySourceId":"registry-NCT06542874-20260920","treatmentContext":"Oral or subcutaneous zenagamtide, formerly amycretin, compared with matching placebo within route cohorts.","primaryQuestion":"Change in HbA1c from baseline to week 36.","interpretation":"Both reports share NCT06542874: 186 participants in the oral cohort and 262 in the subcutaneous cohort. They are two route reports within one registered study, not independent trial replications.","evidenceState":"reviewed-results","anchor":"study-nct06542874","versionPath":"/studies/nct06542874/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"amycretin","reviewVersion":2,"studyHeading":"Oral zenagamtide: phase 2 diabetes cohort","studySha256":"b76f359f2056b39ea885639132874f9e3be9361b60e0e466dc2d880839f90605","pmid":"42532079","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/amycretin/synthesis/versions/2/","identityKey":"registry-NCT06542874-20260920:42532079","study":{"heading":"Oral zenagamtide: phase 2 diabetes cohort","sourceIds":["synthesis-pubmed-42532079-v2"],"design":{"text":"A blinded randomized placebo-controlled study assessed 36-week glycated hemoglobin change under NCT06542874.","sourceIds":["synthesis-pubmed-42532079-v2"]},"population":{"text":"This report included 186 adults with type 2 diabetes receiving metformin with or without an SGLT2 inhibitor.","sourceIds":["synthesis-pubmed-42532079-v2"]},"outcomes":{"text":"All three active groups improved glycated hemoglobin compared with placebo. Gastrointestinal events were common; seven participants in active groups had serious adverse events.","sourceIds":["synthesis-pubmed-42532079-v2"]},"limitations":{"text":"The primary analysis used on-treatment data without rescue medication. Glycemic improvement does not establish reduction in long-term complications; this cohort shares a protocol with the subcutaneous report.","sourceIds":["synthesis-pubmed-42532079-v2"]}}},{"peptideSlug":"amycretin","reviewVersion":2,"studyHeading":"Subcutaneous zenagamtide: phase 2 diabetes cohort","studySha256":"078c3e3e7d90a0c80752150234f4818ca85380c4760abed3db8998e2c60aaa8c","pmid":"42532080","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/amycretin/synthesis/versions/2/","identityKey":"registry-NCT06542874-20260920:42532080","study":{"heading":"Subcutaneous zenagamtide: phase 2 diabetes cohort","sourceIds":["synthesis-pubmed-42532080-v2"],"design":{"text":"A blinded randomized placebo-controlled study assessed 36-week glycated hemoglobin change under NCT06542874.","sourceIds":["synthesis-pubmed-42532080-v2"]},"population":{"text":"This route cohort randomized 262 adults with type 2 diabetes; 261 received treatment.","sourceIds":["synthesis-pubmed-42532080-v2"]},"outcomes":{"text":"Active groups improved glycated hemoglobin compared with placebo. Gastrointestinal adverse events were common; serious adverse events were reported in active and placebo groups.","sourceIds":["synthesis-pubmed-42532080-v2"]},"limitations":{"text":"This is a route cohort within the same protocol as the oral report, not evidence from an unrelated replication. Follow-up and surrogate endpoints limit conclusions about long-term outcomes.","sourceIds":["synthesis-pubmed-42532080-v2"]}}}]},{"nctId":"NCT04026113","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Linaclotide: pediatric functional constipation","topic":"Gastroenterology","treatmentKind":"single","peptideSlugs":["linaclotide"],"registrySourceId":"registry-NCT04026113-20260920","treatmentContext":"Linaclotide versus placebo in the functional-constipation cohort of a pediatric trial.","primaryQuestion":"For functional constipation, change in weekly spontaneous bowel-movement frequency over 12 weeks; the registry has a separate primary endpoint for its IBS-C cohort.","interpretation":"The registry covers 438 participants across two conditions. This report concerns 330 randomized children with functional constipation, of whom 328 received treatment.","evidenceState":"reviewed-results","anchor":"study-nct04026113","versionPath":"/studies/nct04026113/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"linaclotide","reviewVersion":1,"studyHeading":"Pediatric functional constipation","studySha256":"cc2b8e139045f1a14098da63d83d679f44a3c42ffc575bacb45b46e4b0712e81","pmid":"38211604","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/linaclotide/synthesis/versions/1/","identityKey":"registry-NCT04026113-20260920:38211604","study":{"heading":"Pediatric functional constipation","sourceIds":["synthesis-pubmed-38211604-v1"],"design":{"text":"Randomized, double-blind, placebo-controlled phase 3 trial lasting 12 weeks.","sourceIds":["synthesis-pubmed-38211604-v1"]},"population":{"text":"330 children aged 6–17 years were randomized; 328 received treatment and 293 completed.","sourceIds":["synthesis-pubmed-38211604-v1"]},"outcomes":{"text":"The adjusted between-group difference was 1.17 additional spontaneous bowel movements per week. Diarrhea occurred in seven of 164 active-group and three of 164 placebo participants; one active-group participant required hospitalization for dehydration.","sourceIds":["synthesis-pubmed-38211604-v1"]},"limitations":{"text":"The trial addresses functional constipation in the enrolled age range. Its findings cannot establish safety in younger children or replace age-specific label warnings.","sourceIds":["synthesis-pubmed-38211604-v1"]}}}]},{"nctId":"NCT01621178","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"AWARD-7: diabetes with chronic kidney disease","topic":"Diabetes","treatmentKind":"single","peptideSlugs":["dulaglutide"],"registrySourceId":"registry-NCT01621178-20260920","treatmentContext":"Dulaglutide versus insulin glargine as basal therapy, with insulin lispro in all groups.","primaryQuestion":"Change in HbA1c at week 26.","interpretation":"The study continued for 52 weeks, but the primary comparison was glycemic control at week 26. Kidney measurements were secondary outcomes.","evidenceState":"reviewed-results","anchor":"study-nct01621178","versionPath":"/studies/nct01621178/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"dulaglutide","reviewVersion":1,"studyHeading":"AWARD-7: diabetes with chronic kidney disease","studySha256":"0521428f3e6f21c4093a37a0d8dff08781fdc8f05ffbb56c1f0af457933e88f0","pmid":"29910024","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/dulaglutide/synthesis/versions/1/","identityKey":"registry-NCT01621178-20260920:29910024","study":{"heading":"AWARD-7: diabetes with chronic kidney disease","sourceIds":["synthesis-pubmed-29910024-v1"],"design":{"text":"An open-label randomized trial compared dulaglutide with insulin glargine, with insulin lispro in all groups, over 52 weeks.","sourceIds":["synthesis-pubmed-29910024-v1"]},"population":{"text":"The study randomized 577 adults with type 2 diabetes and stage 3–4 chronic kidney disease.","sourceIds":["synthesis-pubmed-29910024-v1"]},"outcomes":{"text":"Dulaglutide met the prespecified noninferiority criterion for glycated hemoglobin change at 26 weeks. At 52 weeks, estimated filtration rates were higher with dulaglutide; nausea and diarrhea were more frequent.","sourceIds":["synthesis-pubmed-29910024-v1"]},"limitations":{"text":"Kidney measures were secondary outcomes. This trial cannot establish a general prevention claim for kidney failure or isolate the effects of background insulin treatment.","sourceIds":["synthesis-pubmed-29910024-v1"]}}}]},{"nctId":"NCT02963766","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"AWARD-PEDS: diabetes in youths","topic":"Diabetes","treatmentKind":"single","peptideSlugs":["dulaglutide"],"registrySourceId":"registry-NCT02963766-20260920","treatmentContext":"Dulaglutide versus placebo in youths with type 2 diabetes, followed by an open-label extension.","primaryQuestion":"Change in HbA1c at week 26, pooling the dulaglutide groups.","interpretation":"The placebo-controlled comparison lasted 26 weeks; participants originally receiving placebo then received dulaglutide. The later extension is not another concurrent placebo comparison.","evidenceState":"reviewed-results","anchor":"study-nct02963766","versionPath":"/studies/nct02963766/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"dulaglutide","reviewVersion":1,"studyHeading":"AWARD-PEDS: glycemic control in youths","studySha256":"2c28562d483b061a8ca09a0caabeb48970d40b8b1da9f39c8866c5bcd5feaab2","pmid":"35658022","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/dulaglutide/synthesis/versions/1/","identityKey":"registry-NCT02963766-20260920:35658022","study":{"heading":"AWARD-PEDS: glycemic control in youths","sourceIds":["synthesis-pubmed-35658022-v1"],"design":{"text":"A blinded randomized placebo-controlled study evaluated a 26-week primary endpoint, followed by an open-label extension.","sourceIds":["synthesis-pubmed-35658022-v1"]},"population":{"text":"The trial randomized 154 participants aged 10 to under 18 with type 2 diabetes.","sourceIds":["synthesis-pubmed-35658022-v1"]},"outcomes":{"text":"Glycated hemoglobin decreased in the dulaglutide groups and increased with placebo. BMI change did not differ between groups; gastrointestinal adverse events were more frequent with dulaglutide.","sourceIds":["synthesis-pubmed-35658022-v1"]},"limitations":{"text":"The primary outcome was glycemic control, not cardiovascular events or long-term complications. The short blinded period limits longer-term conclusions; PubMed links subsequent correspondence.","sourceIds":["synthesis-pubmed-35658022-v1"]}}}]},{"nctId":"NCT05607680","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"GLORY-1: weight management in China","topic":"Weight management","treatmentKind":"single","peptideSlugs":["mazdutide"],"registrySourceId":"registry-NCT05607680-20260920","treatmentContext":"Mazdutide versus placebo in Chinese adults with overweight or obesity.","primaryQuestion":"Percentage weight change and the proportion losing at least 5% of baseline weight at week 32.","interpretation":"The study continued to week 48, but the coprimary endpoints were assessed at week 32. Its population and analysis definition should accompany any quoted weight result.","evidenceState":"reviewed-results","anchor":"study-nct05607680","versionPath":"/studies/nct05607680/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"mazdutide","reviewVersion":1,"studyHeading":"GLORY-1: obesity in China","studySha256":"f341004289dbcce0a6c6ce380234977c165c8a8e7c89e14c3caa800667ca78cf","pmid":"40421736","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/mazdutide/synthesis/versions/1/","identityKey":"registry-NCT05607680-20260920:40421736","study":{"heading":"GLORY-1: obesity in China","sourceIds":["synthesis-pubmed-40421736-v1"],"design":{"text":"Randomized, double-blind, placebo-controlled phase 3 trial; NCT05607680.","sourceIds":["synthesis-pubmed-40421736-v1"]},"population":{"text":"610 adults with overweight or obesity participated.","sourceIds":["synthesis-pubmed-40421736-v1"]},"outcomes":{"text":"At week 32, intention-to-treat weight changes were −10.09% and −12.55% in active groups versus +0.45% with placebo. Gastrointestinal adverse events were common; adverse-event discontinuation occurred in 1.5%, 0.5% and 1.0%, respectively.","sourceIds":["synthesis-pubmed-40421736-v1"]},"limitations":{"text":"The study concerns its enrolled population and prespecified follow-up. Weight change alone cannot establish cardiovascular benefit or longer-term safety.","sourceIds":["synthesis-pubmed-40421736-v1"]}}}]},{"nctId":"NCT04771273","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Survodutide: MASH and fibrosis","topic":"Liver disease","treatmentKind":"single","peptideSlugs":["survodutide"],"registrySourceId":"registry-NCT04771273-20260920","treatmentContext":"Survodutide versus placebo in adults with biopsy-confirmed steatohepatitis and fibrosis.","primaryQuestion":"Improvement in liver histology after 48 weeks, with analyses by planned and actual maintenance treatment.","interpretation":"The reported primary result was improvement in steatohepatitis without worsening fibrosis. Improvement in fibrosis itself was a separate secondary outcome.","evidenceState":"reviewed-results","anchor":"study-nct04771273","versionPath":"/studies/nct04771273/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"survodutide","reviewVersion":2,"studyHeading":"Phase 2 MASH and fibrosis trial","studySha256":"be4c714dfb0124043d288e61d70365b7a98d474c07e82298f1543ee6ea56a212","pmid":"38847460","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/survodutide/synthesis/versions/2/","identityKey":"registry-NCT04771273-20260920:38847460","study":{"heading":"Phase 2 MASH and fibrosis trial","sourceIds":["synthesis-pubmed-38847460-v2"],"design":{"text":"A randomized, placebo-controlled Phase 2 trial assessed histologic improvement in steatohepatitis without worsening fibrosis over 48 weeks.","sourceIds":["synthesis-pubmed-38847460-v2"]},"population":{"text":"The trial treated 293 adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis and fibrosis stages F1 through F3.","sourceIds":["synthesis-pubmed-38847460-v2"]},"outcomes":{"text":"Improvement in steatohepatitis without worsening fibrosis was reported in 43% to 62% across survodutide groups and 14% with placebo. Improvement in fibrosis by at least one stage was reported in 34% to 36% and 22%, respectively.","sourceIds":["synthesis-pubmed-38847460-v2"]},"limitations":{"text":"The sponsor-funded, 48-week Phase 2 trial was not designed to establish long-term liver-related clinical outcomes or uncommon harms, and the fibrosis result was a secondary endpoint.","sourceIds":["synthesis-pubmed-38847460-v2"]}}}]},{"nctId":"NCT05989711","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"IMPACT: biopsy-confirmed MASH","topic":"Liver disease","treatmentKind":"single","peptideSlugs":["pemvidutide"],"registrySourceId":"registry-NCT05989711-20260920","treatmentContext":"Pemvidutide versus placebo in adults with biopsy-confirmed steatohepatitis and stage F2 or F3 fibrosis.","primaryQuestion":"Two histology outcomes at week 24: disease resolution without worsening fibrosis, and fibrosis improvement without worsening disease; the registry also lists adverse events through week 52.","interpretation":"The selected publication reports the 24-week analysis. One histology endpoint was met and the other was not; this should not be summarized as demonstrated fibrosis benefit.","evidenceState":"reviewed-results","anchor":"study-nct05989711","versionPath":"/studies/nct05989711/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"pemvidutide","reviewVersion":1,"studyHeading":"IMPACT: biopsy-confirmed MASH","studySha256":"328514ff8a1dfb45dace3b561568ba441fd0f17995b232653fc62212761b9b35","pmid":"41237796","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/pemvidutide/synthesis/versions/1/","identityKey":"registry-NCT05989711-20260920:41237796","study":{"heading":"IMPACT: biopsy-confirmed MASH","sourceIds":["synthesis-pubmed-41237796-v1"],"design":{"text":"Randomized, double-blind, placebo-controlled phase 2 trial; NCT05989711; two coprimary histology endpoints at week 24.","sourceIds":["synthesis-pubmed-41237796-v1"]},"population":{"text":"212 participants with MASH and stage F2 or F3 fibrosis participated.","sourceIds":["synthesis-pubmed-41237796-v1"]},"outcomes":{"text":"The study met the endpoint of MASH resolution without worsening fibrosis, but did not meet the fibrosis-improvement endpoint without worsening MASH. Adverse events were reported in 78% and 81% of active groups versus 67% with placebo.","sourceIds":["synthesis-pubmed-41237796-v1"]},"limitations":{"text":"The abstract does not fully describe handling of missing biopsy outcomes. Longer follow-up was ongoing; a favorable disease-activity endpoint does not establish fibrosis benefit or fewer clinical events.","sourceIds":["synthesis-pubmed-41237796-v1"]}}}]},{"nctId":"NCT00123253","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Tesamorelin: visceral fat in HIV","topic":"Endocrinology","treatmentKind":"single","peptideSlugs":["tesamorelin"],"registrySourceId":"registry-NCT00123253-20260920","treatmentContext":"Tesamorelin versus placebo in people with HIV-associated abdominal fat accumulation.","primaryQuestion":"Visceral adipose tissue; the retrieved primary-outcome field does not specify a time frame.","interpretation":"The publication reports a 26-week comparison using imaging of abdominal fat. That result is not a cardiovascular-outcome trial or a general-obesity result.","evidenceState":"reviewed-results","anchor":"study-nct00123253","versionPath":"/studies/nct00123253/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"tesamorelin","reviewVersion":1,"studyHeading":"Twenty-six-week visceral-fat trial","studySha256":"98b13c7d4a22134a72adb487d931446f8c39b9c9f1512a79deebcdfbbef3a5f3","pmid":"18057338","reviewedAt":"2026-08-19","reviewVersionReviewedAt":"2026-08-19","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/tesamorelin/synthesis/versions/1/","identityKey":"registry-NCT00123253-20260920:18057338","study":{"heading":"Twenty-six-week visceral-fat trial","sourceIds":["synthesis-pubmed-18057338-v1"],"design":{"text":"A randomized, placebo-controlled trial assessed computed-tomography visceral adipose tissue and metabolic measures over 26 weeks.","sourceIds":["synthesis-pubmed-18057338-v1"]},"population":{"text":"The trial randomized 412 adults living with HIV who had abdominal fat accumulation during antiretroviral therapy; 86% were men.","sourceIds":["synthesis-pubmed-18057338-v1"]},"outcomes":{"text":"Visceral adipose tissue reportedly decreased by 15.2% with tesamorelin and increased by 5.0% with placebo. More participants receiving tesamorelin withdrew because of an adverse event, while the groups did not differ significantly in the reported glycemic measures.","sourceIds":["synthesis-pubmed-18057338-v1"]},"limitations":{"text":"The 26-week trial was limited to adults living with HIV and treatment-associated abdominal fat accumulation and did not establish longer-term clinical outcomes.","sourceIds":["synthesis-pubmed-18057338-v1"]}}}]},{"nctId":"NCT01263717","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Tesamorelin: abdominal and liver fat in HIV","topic":"Liver disease","treatmentKind":"single","peptideSlugs":["tesamorelin"],"registrySourceId":"registry-NCT01263717-20260920","treatmentContext":"Tesamorelin versus placebo in antiretroviral-treated patients with HIV and abdominal fat accumulation.","primaryQuestion":"Change in visceral adipose tissue and liver fat at six months.","interpretation":"The registry lists 54 enrolled; the paper describes 50 randomized and 48 treated. This small, single-center study measured fat changes rather than long-term clinical outcomes.","evidenceState":"reviewed-results","anchor":"study-nct01263717","versionPath":"/studies/nct01263717/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"tesamorelin","reviewVersion":1,"studyHeading":"Six-month visceral- and liver-fat trial","studySha256":"a4452df6efaf6064c4593d717d3924e00b2cafe30776c79d8d447df0811aeb4c","pmid":"25038357","reviewedAt":"2026-08-19","reviewVersionReviewedAt":"2026-08-19","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/tesamorelin/synthesis/versions/1/","identityKey":"registry-NCT01263717-20260920:25038357","study":{"heading":"Six-month visceral- and liver-fat trial","sourceIds":["synthesis-pubmed-25038357-v1"],"design":{"text":"A double-blind, randomized, placebo-controlled preliminary trial assessed visceral adipose tissue, liver fat, and metabolic measures over six months.","sourceIds":["synthesis-pubmed-25038357-v1"]},"population":{"text":"The single-center trial enrolled 50 antiretroviral-treated adults living with HIV and abdominal fat accumulation; 48 received study treatment.","sourceIds":["synthesis-pubmed-25038357-v1"]},"outcomes":{"text":"The reported treatment difference was -42 square centimeters for visceral adipose tissue and -2.9 percentage points for liver fat. The six-month glucose changes were not statistically significant.","sourceIds":["synthesis-pubmed-25038357-v1"]},"limitations":{"text":"The preliminary study was small, single-center, and six months long; the authors stated that further study was needed to determine clinical importance and long-term consequences.","sourceIds":["synthesis-pubmed-25038357-v1"]}}}]},{"nctId":"NCT00672074","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Ipamorelin: gastrointestinal recovery after surgery","topic":"Gastroenterology","treatmentKind":"single","peptideSlugs":["ipamorelin"],"registrySourceId":"registry-NCT00672074-20260920","treatmentContext":"Intravenous ipamorelin versus placebo after bowel-resection surgery.","primaryQuestion":"Recovery of gastrointestinal function, assessed daily until hospital discharge.","interpretation":"The report describes 117 enrolled and 114 in safety and modified intention-to-treat analyses. The primary efficacy difference was not statistically significant; this route and setting do not establish effects for other proposed uses.","evidenceState":"reviewed-results","anchor":"study-nct00672074","versionPath":"/studies/nct00672074/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"ipamorelin","reviewVersion":2,"studyHeading":"Postoperative ileus: a placebo-controlled phase 2 trial","studySha256":"c546460b73071cdf394556915da903f9f7d4871f101f76393fc4ec9cc6041411","pmid":"25331030","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/ipamorelin/synthesis/versions/2/","identityKey":"registry-NCT00672074-20260920:25331030","study":{"heading":"Postoperative ileus: a placebo-controlled phase 2 trial","sourceIds":["synthesis-pubmed-25331030-v2"],"design":{"text":"A multicenter blinded randomized placebo-controlled study assessed recovery after bowel resection.","sourceIds":["synthesis-pubmed-25331030-v2"]},"population":{"text":"The trial enrolled 117 adults; 114 were included in its safety and modified intent-to-treat populations.","sourceIds":["synthesis-pubmed-25331030-v2"]},"outcomes":{"text":"Time to a tolerated solid meal was not significantly different between groups. Treatment-emergent adverse events occurred in 87.5% with ipamorelin and 94.8% with placebo.","sourceIds":["synthesis-pubmed-25331030-v2"]},"limitations":{"text":"The study was small and included varied underlying conditions. A nonsignificant result does not prove equivalence, and these postoperative findings do not establish safety for other uses or routes.","sourceIds":["synthesis-pubmed-25331030-v2"]}}}]},{"nctId":"NCT04163874","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Pramlintide: automated delivery and meal announcements","topic":"Diabetes","treatmentKind":"combination","peptideSlugs":["pramlintide"],"registrySourceId":"registry-NCT04163874-20260920","treatmentContext":"Automated insulin plus pramlintide with simpler meal announcements compared with automated insulin plus placebo and carbohydrate counting in a crossover study.","primaryQuestion":"Two primary comparisons over 12-day assessment periods: time with glucose in the target range and the Emotional Burden score from the Diabetes Distress Scale.","interpretation":"The comparison changes both the drug combination and the meal-announcement approach. The publication describes 32 enrolled and 30 completing analysis; the registry lists 36 enrolled. Glucose noninferiority does not establish reduced emotional burden.","evidenceState":"reviewed-results","anchor":"study-nct04163874","versionPath":"/studies/nct04163874/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"pramlintide","reviewVersion":1,"studyHeading":"Experimental automated delivery","studySha256":"c7c45abb494694dea81f2a992a7d6819aa24e7b70823b2a55291b9ecffd0f5a1","pmid":"38906614","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/pramlintide/synthesis/versions/1/","identityKey":"registry-NCT04163874-20260920:38906614","study":{"heading":"Experimental automated delivery","sourceIds":["synthesis-pubmed-38906614-v1"],"design":{"text":"Randomized crossover comparison of three automated-delivery approaches, each studied for 14 days.","sourceIds":["synthesis-pubmed-38906614-v1"]},"population":{"text":"32 participants enrolled; 30 completing all interventions were analyzed, including 15 adults and 15 adolescents.","sourceIds":["synthesis-pubmed-38906614-v1"]},"outcomes":{"text":"The insulin-and-pramlintide system with simple meal announcements met the prespecified glucose-control noninferiority comparison but did not improve emotional burden. Gastrointestinal symptoms occurred more often with pramlintide; no serious adverse events occurred.","sourceIds":["synthesis-pubmed-38906614-v1"]},"limitations":{"text":"The small, short crossover trial excluded noncompleters from the primary analysis. It evaluates a combined device-and-drug approach and cannot establish longer-term safety or a broader approved indication.","sourceIds":["synthesis-pubmed-38906614-v1"]}}}]},{"nctId":"NCT01382719","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Bremelanotide: phase 2 sexual-function study","topic":"Sexual health","treatmentKind":"single","peptideSlugs":["bremelanotide"],"registrySourceId":"registry-NCT01382719-20260920","treatmentContext":"Bremelanotide versus placebo in premenopausal women with selected sexual-function disorders.","primaryQuestion":"Change in the number of satisfying sexual events per month during 12 weeks of randomized treatment.","interpretation":"The registry lists 612 enrolled while the report describes 327 in its efficacy population. The positive result pools selected treatment groups; this phase 2 endpoint should not be substituted for the endpoints of later trials.","evidenceState":"reviewed-results","anchor":"study-nct01382719","versionPath":"/studies/nct01382719/versions/1/","readingNotes":[{"heading":"Why the participant counts differ","text":"The full text reports 612 enrolled, 397 randomized, 394 in the safety population, 327 with the follow-up needed for efficacy analysis, and 293 completers. These counts describe different stages, not conflicting estimates of the same population.","sourceId":"fulltext-PMC5384512-20260920","sectionIds":["section10-whe-2016-0018"]},{"heading":"Primary result versus exploratory secondary findings","text":"The primary comparison pooled two treatment groups. The first secondary endpoint in the prespecified testing sequence was not significant, so the paper treats all secondary endpoints as exploratory, with nominal p values. Favorable secondary results do not override that testing hierarchy.","sourceId":"fulltext-PMC5384512-20260920","sectionIds":["section7-whe-2016-0018","section12-whe-2016-0018"]}],"reports":[{"peptideSlug":"bremelanotide","reviewVersion":1,"studyHeading":"Phase 2 dose-finding study","studySha256":"610e7732c2b5fa8274d61ca0ac2f547429db39f47d6d54f71833ac9691c0216d","pmid":"27181790","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/bremelanotide/synthesis/versions/1/","identityKey":"registry-NCT01382719-20260920:27181790","study":{"heading":"Phase 2 dose-finding study","sourceIds":["synthesis-pubmed-27181790-v1"],"design":{"text":"A randomized placebo-controlled study assessed outcomes over 12 weeks.","sourceIds":["synthesis-pubmed-27181790-v1"]},"population":{"text":"The efficacy analysis included 327 premenopausal women with female sexual dysfunction.","sourceIds":["synthesis-pubmed-27181790-v1"]},"outcomes":{"text":"The pooled active groups improved reported satisfying sexual events and questionnaire measures compared with placebo; nausea, flushing and headache were reported.","sourceIds":["synthesis-pubmed-27181790-v1"]},"limitations":{"text":"Pooled exposure groups, a different primary endpoint and short follow-up limit comparison with phase 3 results. This report is not a head-to-head comparison with another medicine.","sourceIds":["synthesis-pubmed-27181790-v1"]}}}]},{"nctId":"NCT03085095","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"HERO: androgen suppression in prostate cancer","topic":"Oncology","treatmentKind":"single","peptideSlugs":["leuprolide"],"registrySourceId":"registry-NCT03085095-20260920","treatmentContext":"Relugolix versus leuprolide in men with advanced prostate cancer; leuprolide was the active comparator.","primaryQuestion":"Sustained testosterone suppression from day 29 through day 337.","interpretation":"The paper describes 930 treated participants, while the registry lists 1,134 enrolled across the registered study. The primary endpoint concerns testosterone suppression rather than cancer survival.","evidenceState":"reviewed-results","anchor":"study-nct03085095","versionPath":"/studies/nct03085095/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"leuprolide","reviewVersion":2,"studyHeading":"HERO androgen-deprivation trial","studySha256":"491cbe9c809edef770cf4f624e8a8daa54ff653e569c183600ea7f9eaba4fc98","pmid":"32469183","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/leuprolide/synthesis/versions/2/","identityKey":"registry-NCT03085095-20260920:32469183","study":{"heading":"HERO androgen-deprivation trial","sourceIds":["synthesis-pubmed-32469183-v2"],"design":{"text":"A sponsor-funded, randomized Phase 3 trial compared oral relugolix with leuprolide for 48 weeks; sustained testosterone suppression was the primary endpoint.","sourceIds":["synthesis-pubmed-32469183-v2"]},"population":{"text":"The report describes 930 men with advanced prostate cancer who received treatment: 622 received relugolix and 308 received leuprolide. These are treated-participant counts, not a stated count of everyone randomized.","sourceIds":["synthesis-pubmed-32469183-v2"]},"outcomes":{"text":"Sustained testosterone suppression was reported for 96.7% of the relugolix group and 88.8% of the leuprolide group, meeting the trial's noninferiority and superiority criteria for that endpoint.","sourceIds":["synthesis-pubmed-32469183-v2"]},"limitations":{"text":"Leuprolide was the comparator, not the experimental treatment, and the primary result concerned testosterone suppression rather than cancer progression or survival.","sourceIds":["synthesis-pubmed-32469183-v2"]}}}]},{"nctId":"NCT01430195","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Afamelanotide with phototherapy: vitiligo","topic":"Skin and wound research","treatmentKind":"combination","peptideSlugs":["afamelanotide"],"registrySourceId":"registry-NCT01430195-20260920","treatmentContext":"Afamelanotide plus narrowband UV-B phototherapy compared with phototherapy alone in adults with nonsegmental vitiligo.","primaryQuestion":"Changes in pigmentation assessed with VASI and VETF measures across specified body regions over six months.","interpretation":"The report describes 55 randomized participants with skin phototypes III to VI; the registry lists 56 enrolled. This combination comparison does not isolate the effect of afamelanotide used alone.","evidenceState":"reviewed-results","anchor":"study-nct01430195","versionPath":"/studies/nct01430195/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"afamelanotide","reviewVersion":1,"studyHeading":"Vitiligo: afamelanotide plus phototherapy","studySha256":"77497637b6527718cc173833903608743bd3a4153311516776ae49a232909a94","pmid":"25230094","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/afamelanotide/synthesis/versions/1/","identityKey":"registry-NCT01430195-20260920:25230094","study":{"heading":"Vitiligo: afamelanotide plus phototherapy","sourceIds":["synthesis-pubmed-25230094-v1"],"design":{"text":"A randomized multicenter study compared afamelanotide plus narrowband UV-B with phototherapy alone.","sourceIds":["synthesis-pubmed-25230094-v1"]},"population":{"text":"The study enrolled 55 adults with nonsegmental vitiligo and Fitzpatrick skin phototypes III–VI.","sourceIds":["synthesis-pubmed-25230094-v1"]},"outcomes":{"text":"The combination group had greater reported repigmentation at day 168. Erythema occurred in both groups; nausea and minor infections were reported in the combination group.","sourceIds":["synthesis-pubmed-25230094-v1"]},"limitations":{"text":"The study does not isolate afamelanotide without phototherapy or establish results in all skin phototypes. PubMed links subsequent correspondence about the study.","sourceIds":["synthesis-pubmed-25230094-v1"]}}}]},{"nctId":"NCT01272219","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"SCALE: weight management without diabetes","topic":"Weight management","treatmentKind":"single","peptideSlugs":["liraglutide"],"registrySourceId":"registry-NCT01272219-20260920","treatmentContext":"Liraglutide versus placebo alongside lifestyle intervention in adults with overweight or obesity, excluding diabetes.","primaryQuestion":"Weight change and the proportions losing at least 5% or more than 10% of baseline weight at week 56; the registry also includes a later diabetes-onset endpoint.","interpretation":"This paper reports the 56-week comparison. The registered 160-week diabetes-onset endpoint belongs to a longer follow-up question and should not be inferred from this report.","evidenceState":"reviewed-results","anchor":"study-nct01272219","versionPath":"/studies/nct01272219/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"liraglutide","reviewVersion":1,"studyHeading":"SCALE weight-management trial","studySha256":"0ebdb176b8a79bc3f6d47ede7e6d24b822f94c290bd2fe681cee9592afd2bf74","pmid":"26132939","reviewedAt":"2026-08-19","reviewVersionReviewedAt":"2026-08-19","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/liraglutide/synthesis/versions/1/","identityKey":"registry-NCT01272219-20260920:26132939","study":{"heading":"SCALE weight-management trial","sourceIds":["synthesis-pubmed-26132939-v1"],"design":{"text":"A double-blind, randomized, placebo-controlled trial assessed body-weight change over 56 weeks alongside lifestyle counseling.","sourceIds":["synthesis-pubmed-26132939-v1"]},"population":{"text":"The trial randomized 3,731 adults without type 2 diabetes who had obesity, or overweight with dyslipidemia or hypertension.","sourceIds":["synthesis-pubmed-26132939-v1"]},"outcomes":{"text":"Reported mean weight loss was 8.4 kilograms with liraglutide and 2.8 kilograms with placebo. At least 5% weight loss was reported for 63.2% and 27.1%, respectively, and gastrointestinal events were common.","sourceIds":["synthesis-pubmed-26132939-v1"]},"limitations":{"text":"The sponsor-funded trial combined treatment with lifestyle counseling, excluded type 2 diabetes, and used imputation for the reported mean weight-change analysis.","sourceIds":["synthesis-pubmed-26132939-v1"]}}}]},{"nctId":"NCT03856047","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Cagrilintide: phase 2 weight management","topic":"Weight management","treatmentKind":"single","peptideSlugs":["cagrilintide","liraglutide"],"registrySourceId":"registry-NCT03856047-20260920","treatmentContext":"Cagrilintide compared with placebo and liraglutide in adults with overweight or obesity, excluding diabetes.","primaryQuestion":"Percentage change in body weight at week 26.","interpretation":"The trial included 706 randomized participants in total. The active groups were not masked from one another; the masking concerned active treatment versus placebo. The report distinguishes trial-product and treatment-policy analyses.","evidenceState":"reviewed-results","anchor":"study-nct03856047","versionPath":"/studies/nct03856047/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"cagrilintide","reviewVersion":3,"studyHeading":"Phase 2 weight-management trial","studySha256":"266cadf90ad07c34b9ac4cba747f934f418061562d5a195c1fff61e1a9aa79e4","pmid":"34798060","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/cagrilintide/synthesis/versions/3/","identityKey":"registry-NCT03856047-20260920:34798060","study":{"heading":"Phase 2 weight-management trial","sourceIds":["synthesis-pubmed-34798060-v3"],"design":{"text":"A multicenter, randomized, placebo-controlled and active-controlled dose-finding trial assessed body-weight change over 26 weeks. Participants and investigators were masked to active treatment versus placebo, but not to the different active treatments.","sourceIds":["synthesis-pubmed-34798060-v3"]},"population":{"text":"The trial randomized 706 adults without diabetes across 57 sites in ten countries, including 99 assigned to liraglutide and 101 to pooled placebo. Participants had obesity, or overweight with hypertension or dyslipidemia.","sourceIds":["synthesis-pubmed-34798060-v3"]},"outcomes":{"text":"Reported mean body-weight reduction ranged from 6.0% to 10.8% across cagrilintide groups and was 3.0% with placebo. Gastrointestinal events occurred more often across cagrilintide groups than with placebo.","sourceIds":["synthesis-pubmed-34798060-v3"]},"limitations":{"text":"This was a sponsor-funded, 26-week Phase 2 dose-finding study in adults without diabetes, with a short off-treatment follow-up and no long-term clinical-outcomes assessment.","sourceIds":["synthesis-pubmed-34798060-v3"]}}}]},{"nctId":"NCT05669599","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"MariTide: phase 2 obesity and diabetes cohorts","topic":"Weight management","treatmentKind":"single","peptideSlugs":["maridebart-cafraglutide"],"registrySourceId":"registry-NCT05669599-20260920","treatmentContext":"Maridebart cafraglutide versus placebo in separate cohorts with obesity, with or without type 2 diabetes.","primaryQuestion":"Percentage change in body weight at week 52.","interpretation":"The 592 randomized participants included 465 without diabetes and 127 with type 2 diabetes. These cohorts and the treatment-policy and efficacy estimates should remain separate.","evidenceState":"reviewed-results","anchor":"study-nct05669599","versionPath":"/studies/nct05669599/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"maridebart-cafraglutide","reviewVersion":1,"studyHeading":"Phase 2 obesity trial","studySha256":"cc6b3fe9e239b2ad3071c29985665c9bb45f61314c52d622d9129ce5f8fe544e","pmid":"40549887","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/maridebart-cafraglutide/synthesis/versions/1/","identityKey":"registry-NCT05669599-20260920:40549887","study":{"heading":"Phase 2 obesity trial","sourceIds":["synthesis-pubmed-40549887-v1"],"design":{"text":"Randomized, placebo-controlled 52-week trial with multiple active groups; NCT05669599.","sourceIds":["synthesis-pubmed-40549887-v1"]},"population":{"text":"592 participants: 465 with obesity without diabetes and 127 with obesity and type 2 diabetes.","sourceIds":["synthesis-pubmed-40549887-v1"]},"outcomes":{"text":"In the intention-to-treat analysis, weight changes ranged from −12.3% to −16.2% versus −2.5% without diabetes, and −8.4% to −12.3% versus −1.7% with diabetes. Gastrointestinal events were common.","sourceIds":["synthesis-pubmed-40549887-v1"]},"limitations":{"text":"Multiple groups and two populations should not be pooled into a single effect. Weight is not a direct measure of cardiovascular outcomes, and longer-term safety remains unresolved.","sourceIds":["synthesis-pubmed-40549887-v1"]}}}]},{"nctId":"NCT05606913","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Mazdutide versus dulaglutide: diabetes in China","topic":"Diabetes","treatmentKind":"single","peptideSlugs":["mazdutide","dulaglutide"],"registrySourceId":"registry-NCT05606913-20260920","treatmentContext":"Mazdutide compared with dulaglutide in Chinese adults with type 2 diabetes inadequately controlled on oral glucose-lowering medicines.","primaryQuestion":"Change in HbA1c from baseline to week 28.","interpretation":"This active-comparator trial concerns selected treatment groups in a specified diabetes population. It does not rank the drugs across other conditions, treatment settings or long-term outcomes.","evidenceState":"reviewed-results","anchor":"study-nct05606913","versionPath":"/studies/nct05606913/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"mazdutide","reviewVersion":1,"studyHeading":"Type 2 diabetes: active comparator","studySha256":"c7dcbc2ba26b459d7c6078e1a1f9d97887c2bfc2a3bbaea664910a1723adde84","pmid":"41407860","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/mazdutide/synthesis/versions/1/","identityKey":"registry-NCT05606913-20260920:41407860","study":{"heading":"Type 2 diabetes: active comparator","sourceIds":["synthesis-pubmed-41407860-v1"],"design":{"text":"Randomized phase 3 comparison with a specified dulaglutide regimen over 28 weeks.","sourceIds":["synthesis-pubmed-41407860-v1"]},"population":{"text":"731 adults in China with type 2 diabetes participated.","sourceIds":["synthesis-pubmed-41407860-v1"]},"outcomes":{"text":"Between-group HbA1c differences favored the two mazdutide groups by 0.24 and 0.30 percentage points; reductions in percentage body-weight change were 3.78 and 5.76 percentage points greater than with dulaglutide. Gastrointestinal events were more frequent with mazdutide.","sourceIds":["synthesis-pubmed-41407860-v1"]},"limitations":{"text":"The comparison is specific to the tested regimens and population, not a ranking against all uses of the comparator or other medicines.","sourceIds":["synthesis-pubmed-41407860-v1"]}}}]},{"nctId":"NCT06354660","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"TRANSCEND-T2D-1: retatrutide in early diabetes","topic":"Diabetes","treatmentKind":"single","peptideSlugs":["retatrutide"],"registrySourceId":"registry-NCT06354660-20260920","treatmentContext":"Retatrutide versus placebo in adults with type 2 diabetes managed with diet and exercise.","primaryQuestion":"Change in HbA1c from baseline to week 40.","interpretation":"The trial randomized 537 of 930 screened participants. Weight change was secondary to the primary glycemic endpoint; this 40-week study does not establish long-term cardiovascular outcomes.","evidenceState":"reviewed-results","anchor":"study-nct06354660","versionPath":"/studies/nct06354660/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"retatrutide","reviewVersion":2,"studyHeading":"TRANSCEND-T2D-1: phase 3 diabetes study","studySha256":"38a0fc80556a2b3a02f7a6061f67df6a569e51be1ae1fcc2ac048bafc5993d00","pmid":"42250575","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/retatrutide/synthesis/versions/2/","identityKey":"registry-NCT06354660-20260920:42250575","study":{"heading":"TRANSCEND-T2D-1: phase 3 diabetes study","sourceIds":["synthesis-pubmed-42250575-v2"],"design":{"text":"A blinded randomized placebo-controlled trial assessed 40-week glycated hemoglobin change under NCT06354660.","sourceIds":["synthesis-pubmed-42250575-v2"]},"population":{"text":"The trial randomized 537 adults with type 2 diabetes inadequately controlled with diet and exercise alone.","sourceIds":["synthesis-pubmed-42250575-v2"]},"outcomes":{"text":"Under the treatment-regimen analysis, HbA1c decreased by 1.69–1.94 percentage points across active groups versus 0.81 with placebo. Gastrointestinal events were common; adverse-event discontinuations occurred in 2–5% of active groups and none of the placebo group.","sourceIds":["synthesis-pubmed-42250575-v2"]},"limitations":{"text":"HbA1c and weight changes do not establish prevention of long-term complications. The report recorded two deaths in one active group, which the authors considered unrelated to study treatment; it reported no severe hypoglycemia.","sourceIds":["synthesis-pubmed-42250575-v2"]}}}]},{"nctId":"NCT06066515","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"SYNCHRONIZE-1: survodutide weight management","topic":"Weight management","treatmentKind":"single","peptideSlugs":["survodutide"],"registrySourceId":"registry-NCT06066515-20260920","treatmentContext":"Survodutide versus placebo alongside lifestyle intervention in adults with overweight or obesity, excluding diabetes.","primaryQuestion":"Percentage weight change and the proportion losing at least 5% of baseline weight at week 76.","interpretation":"The paper describes 725 participants and the registry lists 726 enrolled. Its treatment-regimen estimates include treatment discontinuation and other specified intercurrent events; they should not be mixed with efficacy estimates from a different analysis.","evidenceState":"reviewed-results","anchor":"study-nct06066515","versionPath":"/studies/nct06066515/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"survodutide","reviewVersion":2,"studyHeading":"SYNCHRONIZE-1: phase 3 obesity study","studySha256":"058871eda2c32d9dde713483ea1d03ee61ad2474d5e99d692c83c3b138041317","pmid":"42253238","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/survodutide/synthesis/versions/2/","identityKey":"registry-NCT06066515-20260920:42253238","study":{"heading":"SYNCHRONIZE-1: phase 3 obesity study","sourceIds":["synthesis-pubmed-42253238-v2"],"design":{"text":"A blinded randomized placebo-controlled trial assessed percentage weight change and at least 5% weight reduction at 76 weeks, under NCT06066515.","sourceIds":["synthesis-pubmed-42253238-v2"]},"population":{"text":"The report describes 725 adults with obesity or overweight with a related complication, excluding diabetes.","sourceIds":["synthesis-pubmed-42253238-v2"]},"outcomes":{"text":"The treatment-regimen analysis reported mean weight changes of −12.2% and −13.0% in the active groups versus −5.4% with placebo. Gastrointestinal events occurred in 80.9% and 89.7% of active groups versus 47.9% with placebo.","sourceIds":["synthesis-pubmed-42253238-v2"]},"limitations":{"text":"The analysis includes treatment discontinuation and other specified intercurrent events. Weight reduction does not itself establish fewer cardiovascular events or other long-term complications. No deaths were reported.","sourceIds":["synthesis-pubmed-42253238-v2"]}}}]},{"nctId":"NCT06559527","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Zenagamtide: renal function and drug exposure","topic":"Clinical pharmacology","treatmentKind":"single","peptideSlugs":["amycretin"],"registrySourceId":"registry-NCT06559527-20260920","treatmentContext":"A single subcutaneous exposure to zenagamtide, formerly amycretin, in groups with differing renal function; no placebo group.","primaryQuestion":"Total drug exposure, measured as area under the concentration-time curve from time zero to infinity, using samples collected through day 28.","interpretation":"The 42 participants were divided among five renal-function groups. This short pharmacokinetic study does not establish treatment benefit, long-term safety or a dosing recommendation.","evidenceState":"reviewed-results","anchor":"study-nct06559527","versionPath":"/studies/nct06559527/versions/1/","readingNotes":[{"heading":"Exposure differences need interpretation","text":"Adjusted total-exposure estimates were higher in the renal-impairment groups. The authors judged those differences not clinically relevant, but the study was not powered for a statistical comparison of pharmacokinetic parameters. Their interpretation should not be read as proof of identical exposure.","sourceId":"fulltext-PMC13538736-20260920","sectionIds":["dom71096-sec-0009","dom71096-sec-0012","dom71096-sec-0014"]},{"heading":"A short observation in small groups","text":"All 42 participants completed follow-up, with 14 in the normal-function group and seven in each renal-impairment group. No serious treatment-emergent events were reported through day 28. The small sample, single exposure and predominantly White population limit conclusions about longer-term use and broader populations.","sourceId":"fulltext-PMC13538736-20260920","sectionIds":["dom71096-sec-0011","dom71096-sec-0013","dom71096-sec-0014"]}],"reports":[{"peptideSlug":"amycretin","reviewVersion":2,"studyHeading":"Renal-function pharmacokinetic study","studySha256":"813c2db7b5814ed159fa1e10d13e4d103182079ffc67e7cf4b6b1d6a82206f9f","pmid":"42443140","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/amycretin/synthesis/versions/2/","identityKey":"registry-NCT06559527-20260920:42443140","study":{"heading":"Renal-function pharmacokinetic study","sourceIds":["synthesis-pubmed-42443140-v2"],"design":{"text":"A single-exposure study compared pharmacokinetics across renal-function groups with four weeks of follow-up, registered as NCT06559527.","sourceIds":["synthesis-pubmed-42443140-v2"]},"population":{"text":"Forty-two adults participated: 14 with normal renal function and seven each with mild, moderate or severe impairment or end-stage renal disease.","sourceIds":["synthesis-pubmed-42443140-v2"]},"outcomes":{"text":"The authors reported broadly comparable exposure measurements across groups. Treatment-emergent adverse events occurred in 30 of 42 participants; none were serious or severe, and most were mild gastrointestinal events.","sourceIds":["synthesis-pubmed-42443140-v2"]},"limitations":{"text":"Small groups, one exposure and short follow-up do not establish long-term safety or therapeutic benefit in people with kidney disease. The report does not support individualized treatment recommendations.","sourceIds":["synthesis-pubmed-42443140-v2"]}}}]},{"nctId":"NCT06124807","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Mazdutide: US phase 2 weight study","topic":"Weight management","treatmentKind":"single","peptideSlugs":["mazdutide"],"registrySourceId":"registry-NCT06124807-20260920","treatmentContext":"Mazdutide versus placebo in US adults with overweight or obesity, excluding diabetes.","primaryQuestion":"Percentage change in body weight at week 32.","interpretation":"The trial continued to week 48, but its primary weight endpoint was at week 32. Its hypothetical efficacy estimand and US population should remain distinct from the GLORY-1 report.","evidenceState":"reviewed-results","anchor":"study-nct06124807","versionPath":"/studies/nct06124807/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"mazdutide","reviewVersion":1,"studyHeading":"US phase 2 obesity trial","studySha256":"2825586c62858aa50afe9d623ec8b093e9df2a446c920a8ce21a275585269873","pmid":"42628555","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/mazdutide/synthesis/versions/1/","identityKey":"registry-NCT06124807-20260920:42628555","study":{"heading":"US phase 2 obesity trial","sourceIds":["synthesis-pubmed-42628555-v1"],"design":{"text":"Randomized, placebo-controlled phase 2 trial with a week-32 primary endpoint and longer follow-up.","sourceIds":["synthesis-pubmed-42628555-v1"]},"population":{"text":"179 adults with overweight or obesity participated.","sourceIds":["synthesis-pubmed-42628555-v1"]},"outcomes":{"text":"The reported hypothetical-estimand weight changes at week 32 were −7.3%, −15.6% and −18.1% versus −0.9%. Adverse events led to discontinuation in 20% of the highest active group.","sourceIds":["synthesis-pubmed-42628555-v1"]},"limitations":{"text":"A hypothetical estimand is not the same as observed outcomes regardless of discontinuation. Population, follow-up and estimand differences prevent direct comparison with GLORY-1.","sourceIds":["synthesis-pubmed-42628555-v1"]}}}]},{"nctId":"NCT06662539","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"ZUPREME: petrelintide weight study","topic":"Weight management","treatmentKind":"single","peptideSlugs":["petrelintide"],"registrySourceId":"registry-NCT06662539-20260920","treatmentContext":"Petrelintide versus placebo in adults with obesity or overweight with weight-related conditions.","primaryQuestion":"Percentage change in body weight at week 28.","interpretation":"The retrieved registry marks the study completed and enrollment as actual, but contains no posted results. A completed registry status alone does not supply an effect estimate.","evidenceState":"protocol-context","anchor":"study-nct06662539","versionPath":"/studies/nct06662539/versions/1/","readingNotes":[],"reports":[]},{"nctId":"NCT06926842","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"ZUPREME 2: petrelintide with diabetes","topic":"Weight management","treatmentKind":"single","peptideSlugs":["petrelintide"],"registrySourceId":"registry-NCT06926842-20260920","treatmentContext":"Petrelintide versus placebo in adults with overweight or obesity and type 2 diabetes.","primaryQuestion":"Percentage change in body weight at week 28.","interpretation":"This registered population has type 2 diabetes. The retrieved record contains no posted results; this card does not substitute for a published results appraisal.","evidenceState":"protocol-context","anchor":"study-nct06926842","versionPath":"/studies/nct06926842/versions/1/","readingNotes":[],"reports":[]},{"nctId":"NCT01982240","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Plecanatide: first pivotal constipation trial","topic":"Gastroenterology","treatmentKind":"single","peptideSlugs":["plecanatide"],"registrySourceId":"registry-NCT01982240-20260920","treatmentContext":"Plecanatide versus placebo in adults with chronic idiopathic constipation.","primaryQuestion":"A sustained complete spontaneous bowel-movement response over 12 treatment weeks.","interpretation":"The registry distinguishes 1,394 randomizations from 1,346 unique patients in the intention-to-treat population, after excluding repeat enrollments. The abstract’s randomized count is not the efficacy-analysis denominator.","evidenceState":"reviewed-results","anchor":"study-nct01982240","versionPath":"/studies/nct01982240/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"plecanatide","reviewVersion":2,"studyHeading":"Chronic idiopathic constipation: first phase 3 trial","studySha256":"f5f66aa64775e4b5e5203d4f1757460f2923d0b74c00f3f38132fa1c500543f0","pmid":"28169285","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/plecanatide/synthesis/versions/2/","identityKey":"registry-NCT01982240-20260920:28169285","study":{"heading":"Chronic idiopathic constipation: first phase 3 trial","sourceIds":["synthesis-pubmed-28169285-v2"],"design":{"text":"Randomized, double-blind, placebo-controlled trial over 12 weeks with two active groups.","sourceIds":["synthesis-pubmed-28169285-v2"]},"population":{"text":"1,394 adults with chronic idiopathic constipation were randomized.","sourceIds":["synthesis-pubmed-28169285-v2"]},"outcomes":{"text":"Durable bowel-response rates were 21.0% and 19.5% in active groups versus 10.2% with placebo. Diarrhea occurred in 5.9% and 5.7% versus 1.3%.","sourceIds":["synthesis-pubmed-28169285-v2"]},"limitations":{"text":"The endpoint combines frequency and persistence of response. Results concern the enrolled adults and short follow-up, not all constipation causes.","sourceIds":["synthesis-pubmed-28169285-v2"]}}}]},{"nctId":"NCT02122471","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Plecanatide: second pivotal constipation trial","topic":"Gastroenterology","treatmentKind":"single","peptideSlugs":["plecanatide"],"registrySourceId":"registry-NCT02122471-20260920","treatmentContext":"Plecanatide versus placebo in adults with chronic idiopathic constipation.","primaryQuestion":"A sustained complete spontaneous bowel-movement response over 12 treatment weeks.","interpretation":"The registry reports 1,410 randomizations and an intention-to-treat population of 1,337 after excluding repeat enrollments. The closer-reading notes explain which populations support efficacy and safety results.","evidenceState":"reviewed-results","anchor":"study-nct02122471","versionPath":"/studies/nct02122471/versions/1/","readingNotes":[{"heading":"Participant counts describe different groups","text":"The full text reports 1,410 randomizations, 1,402 treated participants in the safety population and 1,337 unique patients in the intention-to-treat analysis. The abstract’s group counts sum to the analysis population. Those denominators should not be interchanged.","sourceId":"fulltext-PMC5673020-20260920","sectionIds":["section15-1756283X17734697","section16-1756283X17734697"]},{"heading":"A sustained response, not a single improved week","text":"The primary responder definition required at least three complete spontaneous bowel movements in a week, with at least one more than baseline, in nine of twelve treatment weeks including three of the final four. Weeks with fewer than four complete diary days counted as nonresponse.","sourceId":"fulltext-PMC5673020-20260920","sectionIds":["section12-1756283X17734697","section15-1756283X17734697"]}],"reports":[{"peptideSlug":"plecanatide","reviewVersion":2,"studyHeading":"Chronic idiopathic constipation: second phase 3 trial","studySha256":"d21bbb5212ec5da2affb0bd6d32ad1cf4caf93be2d864b6fe6d06254d6e7eaf0","pmid":"29147135","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/plecanatide/synthesis/versions/2/","identityKey":"registry-NCT02122471-20260920:29147135","study":{"heading":"Chronic idiopathic constipation: second phase 3 trial","sourceIds":["synthesis-pubmed-29147135-v2"],"design":{"text":"Randomized, double-blind, placebo-controlled 12-week trial.","sourceIds":["synthesis-pubmed-29147135-v2"]},"population":{"text":"The abstract reports groups totaling 1,337 adults with chronic idiopathic constipation.","sourceIds":["synthesis-pubmed-29147135-v2"]},"outcomes":{"text":"Durable responder rates were 20.1% and 20.0% versus 12.8%. Diarrhea occurred in 3.2% and 4.5% versus 1.3%.","sourceIds":["synthesis-pubmed-29147135-v2"]},"limitations":{"text":"This is a separate trial from the first constipation report. Patient diaries and the defined responder threshold need full-report appraisal.","sourceIds":["synthesis-pubmed-29147135-v2"]}}}]},{"nctId":"NCT03339453","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Glucagon: nasal and injected formulations","topic":"Diabetes","treatmentKind":"single","peptideSlugs":["glucagon"],"registrySourceId":"registry-NCT03339453-20260920","treatmentContext":"Nasal versus intramuscular glucagon during controlled insulin-induced hypoglycemia in adults with type 1 diabetes.","primaryQuestion":"The proportion meeting the prespecified glucose-recovery criterion within 30 minutes after administration, without additional intervention.","interpretation":"This was a crossover comparison under controlled clinical conditions. Its primary efficacy analysis and safety population differ, and it did not test caregiver performance in an emergency.","evidenceState":"reviewed-results","anchor":"study-nct03339453","versionPath":"/studies/nct03339453/versions/1/","readingNotes":[{"heading":"The success rate uses an evaluable subset","text":"The full text reports 70 treated participants and 69 who completed both periods. The primary efficacy analysis included 66: three did not meet the low-glucose criterion at one visit, and one withdrew after a single visit. The reported complete success rate refers to the evaluable analysis.","sourceId":"fulltext-PMC7324463-20260920","sectionIds":["Sec13","Sec14"]},{"heading":"Laboratory timing is not emergency performance","text":"The authors note that time to glucose recovery excluded preparation of the injected comparator. Treatment was evaluated in a controlled clinical setting, and the study did not measure ease of use. Its timing results cannot establish performance during an emergency managed by a non-clinician.","sourceId":"fulltext-PMC7324463-20260920","sectionIds":["Sec20"]}],"reports":[{"peptideSlug":"glucagon","reviewVersion":2,"studyHeading":"Nasal versus intramuscular glucagon","studySha256":"a7539fc956b47294bbd92518c498a4c425001d775afeb0d129709783931a078c","pmid":"32514794","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/glucagon/synthesis/versions/2/","identityKey":"registry-NCT03339453-20260920:32514794","study":{"heading":"Nasal versus intramuscular glucagon","sourceIds":["synthesis-pubmed-32514794-v2"],"design":{"text":"Randomized crossover noninferiority study after experimentally induced hypoglycemia.","sourceIds":["synthesis-pubmed-32514794-v2"]},"population":{"text":"The primary efficacy analysis included 66 adults with type 1 diabetes who received both formulations.","sourceIds":["synthesis-pubmed-32514794-v2"]},"outcomes":{"text":"Both formulations achieved treatment success in all 66 evaluable participants within 25 minutes. Mean time to success was 11.4 minutes with nasal and 9.9 minutes with intramuscular glucagon.","sourceIds":["synthesis-pubmed-32514794-v2"]},"limitations":{"text":"The induced-hypoglycemia setting and controlled administration differ from an unplanned emergency. Recovery speed is distinct from preparation time and caregiver usability.","sourceIds":["synthesis-pubmed-32514794-v2"]}}}]},{"nctId":"NCT00730015","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Linaclotide: constipation Trial 303","topic":"Gastroenterology","treatmentKind":"single","peptideSlugs":["linaclotide"],"registrySourceId":"registry-NCT00730015-20260920","treatmentContext":"Linaclotide versus placebo in adults with chronic constipation.","primaryQuestion":"The proportion with at least three complete spontaneous bowel movements per week and at least one more than baseline, for at least nine of twelve weeks.","interpretation":"The registry identifies protocol MCP-103-303 and 643 enrolled participants. Only Trial 303 outcomes from the two-trial paper are shown here; the paper’s total of 1,276 covers both trials.","evidenceState":"reviewed-results","anchor":"study-nct00730015","versionPath":"/studies/nct00730015/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"linaclotide","reviewVersion":2,"studyHeading":"Adult chronic constipation: Trial 303","studySha256":"39973ac36f48be6b5dac64daa248262010b790b370a651dd2bd50cde52633f4a","pmid":"21830967","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/linaclotide/synthesis/versions/2/","identityKey":"registry-NCT00730015-20260920:21830967","study":{"heading":"Adult chronic constipation: Trial 303","sourceIds":["synthesis-pubmed-21830967-v2"],"design":{"text":"A randomized, double-blind, placebo-controlled 12-week trial tested two active groups.","sourceIds":["synthesis-pubmed-21830967-v2"]},"population":{"text":"Adults with chronic constipation participated; the abstract reports 1,276 participants across Trials 303 and 01 together, without a separate Trial 303 count.","sourceIds":["synthesis-pubmed-21830967-v2"]},"outcomes":{"text":"The primary bowel-response endpoint was reached by 21.2% and 19.4% in the two active groups, compared with 3.3% with placebo.","sourceIds":["synthesis-pubmed-21830967-v2"]},"limitations":{"text":"These are the Trial 303 efficacy results. The abstract’s 4.2% diarrhea-related discontinuation figure is reported across active groups in the two-trial publication and is not a separately appraised Trial 303 safety estimate. Follow-up was 12 weeks.","sourceIds":["synthesis-pubmed-21830967-v2"]}}}]},{"nctId":"NCT00765882","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Linaclotide: constipation Trial 01","topic":"Gastroenterology","treatmentKind":"single","peptideSlugs":["linaclotide"],"registrySourceId":"registry-NCT00765882-20260920","treatmentContext":"Linaclotide versus placebo in adults with chronic constipation.","primaryQuestion":"The proportion with at least three complete spontaneous bowel movements per week and at least one more than baseline, for at least nine of twelve weeks.","interpretation":"The registry identifies protocol LIN-MD-01 and 633 enrolled participants. Only Trial 01 outcomes from the two-trial paper are shown here; combined safety reporting should not be assigned to either trial alone.","evidenceState":"reviewed-results","anchor":"study-nct00765882","versionPath":"/studies/nct00765882/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"linaclotide","reviewVersion":2,"studyHeading":"Adult chronic constipation: Trial 01","studySha256":"21d360dbcb18748cf64fdf6574d7e5aa6bd6245a5fd785f00121c6970a29c382","pmid":"21830967","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/linaclotide/synthesis/versions/2/","identityKey":"registry-NCT00765882-20260920:21830967","study":{"heading":"Adult chronic constipation: Trial 01","sourceIds":["synthesis-pubmed-21830967-v2"],"design":{"text":"A randomized, double-blind, placebo-controlled 12-week trial tested two active groups.","sourceIds":["synthesis-pubmed-21830967-v2"]},"population":{"text":"Adults with chronic constipation participated; the abstract reports 1,276 participants across Trials 303 and 01 together, without a separate Trial 01 count.","sourceIds":["synthesis-pubmed-21830967-v2"]},"outcomes":{"text":"The primary bowel-response endpoint was reached by 16.0% and 21.3% in the two active groups, compared with 6.0% with placebo.","sourceIds":["synthesis-pubmed-21830967-v2"]},"limitations":{"text":"These are the Trial 01 efficacy results. The abstract’s combined participant count and diarrhea-related discontinuation figure should not be assigned to Trial 01 alone. Follow-up was 12 weeks.","sourceIds":["synthesis-pubmed-21830967-v2"]}}}]},{"nctId":"NCT00979745","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Afamelanotide: European EPP trial","topic":"Rare disease","treatmentKind":"single","peptideSlugs":["afamelanotide"],"registrySourceId":"registry-NCT00979745-20260920","treatmentContext":"Afamelanotide versus placebo in people with erythropoietic protoporphyria.","primaryQuestion":"Direct sunlight exposure without phototoxicity-related pain between 10:00 and 15:00, from baseline through day 270.","interpretation":"This European protocol used a different daily sunlight window and follow-up period from the US trial in the same paper. The exposure-hour totals are not directly comparable across studies.","evidenceState":"reviewed-results","anchor":"study-nct00979745","versionPath":"/studies/nct00979745/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"afamelanotide","reviewVersion":2,"studyHeading":"EPP: European placebo-controlled trial","studySha256":"ac12986ac8e6f248b13e1deaeb80ab7d9b46d92d367c091578e9ed86176fe732","pmid":"26132941","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/afamelanotide/synthesis/versions/2/","identityKey":"registry-NCT00979745-20260920:26132941","study":{"heading":"EPP: European placebo-controlled trial","sourceIds":["synthesis-pubmed-26132941-v2"],"design":{"text":"A randomized, double-blind, placebo-controlled trial followed pain-free sunlight exposure over nine months.","sourceIds":["synthesis-pubmed-26132941-v2"]},"population":{"text":"The abstract reports 74 participants with erythropoietic protoporphyria in the European trial.","sourceIds":["synthesis-pubmed-26132941-v2"]},"outcomes":{"text":"Median pain-free sunlight exposure was 6.0 hours with afamelanotide versus 0.8 hours with placebo over nine months. The report also counted 77 versus 146 phototoxic reactions.","sourceIds":["synthesis-pubmed-26132941-v2"]},"limitations":{"text":"Exposure measurements and follow-up differ from the US trial. The abstract summarizes safety across both trials, so its overall safety statement is not a separate European-trial estimate or proof about uncommon long-term harms.","sourceIds":["synthesis-pubmed-26132941-v2"]}}}]},{"nctId":"NCT01605136","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Afamelanotide: US EPP trial","topic":"Rare disease","treatmentKind":"single","peptideSlugs":["afamelanotide"],"registrySourceId":"registry-NCT01605136-20260920","treatmentContext":"Afamelanotide versus placebo in people with erythropoietic protoporphyria.","primaryQuestion":"Direct sunlight exposure without pain between 10:00 and 18:00, recorded daily for six months.","interpretation":"The registry reports 93 enrolled participants while the abstract reports 94. That discrepancy remains explicit. The US and European protocols used different daily sunlight windows and follow-up periods.","evidenceState":"reviewed-results","anchor":"study-nct01605136","versionPath":"/studies/nct01605136/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"afamelanotide","reviewVersion":2,"studyHeading":"EPP: US placebo-controlled trial","studySha256":"3a382761563128a8efb081b0c9469dcbf3c82811b04f9f7fed808ba9823e55e9","pmid":"26132941","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/afamelanotide/synthesis/versions/2/","identityKey":"registry-NCT01605136-20260920:26132941","study":{"heading":"EPP: US placebo-controlled trial","sourceIds":["synthesis-pubmed-26132941-v2"],"design":{"text":"A randomized, double-blind, placebo-controlled trial followed pain-free sunlight exposure over six months.","sourceIds":["synthesis-pubmed-26132941-v2"]},"population":{"text":"The abstract reports 94 participants with erythropoietic protoporphyria in the US trial.","sourceIds":["synthesis-pubmed-26132941-v2"]},"outcomes":{"text":"Median pain-free sunlight exposure was 69.4 hours with afamelanotide versus 40.8 hours with placebo over six months.","sourceIds":["synthesis-pubmed-26132941-v2"]},"limitations":{"text":"Exposure measurements and follow-up differ from the European trial. The numeric exposure results should not be directly compared across trials. The abstract’s overall safety statement covers both studies.","sourceIds":["synthesis-pubmed-26132941-v2"]}}}]},{"nctId":"NCT02896192","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Setmelanotide: POMC-deficiency pivotal cohort","topic":"Rare disease","treatmentKind":"single","peptideSlugs":["setmelanotide"],"registrySourceId":"registry-NCT02896192-20260920","treatmentContext":"Setmelanotide in a genetically defined obesity cohort, including response-selected blinded withdrawal.","primaryQuestion":"The proportion of the pivotal cohort reaching at least 10% weight loss after approximately one year.","interpretation":"The registry’s total enrollment is 15; the selected paper reports the ten-person pivotal POMC cohort. The primary one-year result is not a parallel placebo comparison, and the hunger analysis selects initial responders.","evidenceState":"reviewed-results","anchor":"study-nct02896192","versionPath":"/studies/nct02896192/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"setmelanotide","reviewVersion":2,"studyHeading":"POMC-deficiency obesity trial","studySha256":"bd4200e93e062ec966d94a34e9584e5a9e2df232f5253b16cb43658d16763af0","pmid":"33137293","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/setmelanotide/synthesis/versions/2/","identityKey":"registry-NCT02896192-20260920:33137293","study":{"heading":"POMC-deficiency obesity trial","sourceIds":["synthesis-pubmed-33137293-v2"],"design":{"text":"A sponsor-funded, single-arm, open-label phase 3 trial included a blinded placebo-withdrawal sequence for participants who first met a weight-loss threshold.","sourceIds":["synthesis-pubmed-33137293-v2"]},"population":{"text":"Ten participants aged at least six years with POMC-deficiency obesity were included in the full analysis and safety sets.","sourceIds":["synthesis-pubmed-33137293-v2"]},"outcomes":{"text":"Eight of ten participants achieved at least 10% weight loss at approximately one year. The hunger-score analysis involved a selected subset of seven participants aged at least 12 years who had first met the weight-loss threshold.","sourceIds":["synthesis-pubmed-33137293-v2"]},"limitations":{"text":"The primary one-year endpoint lacked a parallel control group. The small cohort and response-selected withdrawal and hunger analyses limit interpretation and do not establish outcomes in other causes of obesity.","sourceIds":["synthesis-pubmed-33137293-v2"]}}}]},{"nctId":"NCT03287960","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Setmelanotide: LEPR-deficiency pivotal cohort","topic":"Rare disease","treatmentKind":"single","peptideSlugs":["setmelanotide"],"registrySourceId":"registry-NCT03287960-20260920","treatmentContext":"Setmelanotide in a genetically defined obesity cohort, including response-selected blinded withdrawal.","primaryQuestion":"The proportion of the pivotal cohort reaching at least 10% weight loss after approximately one year.","interpretation":"The registry’s total enrollment is 15; the selected paper reports the eleven-person pivotal LEPR cohort. The primary one-year result is not a parallel placebo comparison, and the hunger analysis selects initial responders.","evidenceState":"reviewed-results","anchor":"study-nct03287960","versionPath":"/studies/nct03287960/versions/1/","readingNotes":[],"reports":[{"peptideSlug":"setmelanotide","reviewVersion":2,"studyHeading":"LEPR-deficiency obesity trial","studySha256":"1cb4833f40f8ee08d13f7a764340044d0f12be56e10480837c0519cfd63c7bd7","pmid":"33137293","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/setmelanotide/synthesis/versions/2/","identityKey":"registry-NCT03287960-20260920:33137293","study":{"heading":"LEPR-deficiency obesity trial","sourceIds":["synthesis-pubmed-33137293-v2"],"design":{"text":"A sponsor-funded, single-arm, open-label phase 3 trial included a blinded placebo-withdrawal sequence for participants who first met a weight-loss threshold.","sourceIds":["synthesis-pubmed-33137293-v2"]},"population":{"text":"Eleven participants aged at least six years with LEPR-deficiency obesity were included in the full analysis and safety sets.","sourceIds":["synthesis-pubmed-33137293-v2"]},"outcomes":{"text":"Five of eleven participants achieved at least 10% weight loss at approximately one year. The hunger-score analysis involved a selected subset of seven participants aged at least 12 years who had first met the weight-loss threshold.","sourceIds":["synthesis-pubmed-33137293-v2"]},"limitations":{"text":"The primary one-year endpoint lacked a parallel control group. The small cohort and response-selected withdrawal and hunger analyses limit interpretation and do not establish outcomes in other causes of obesity.","sourceIds":["synthesis-pubmed-33137293-v2"]}}}]},{"nctId":"NCT03548935","version":2,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"STEP 1: weight change without diabetes","topic":"Weight management","treatmentKind":"single","peptideSlugs":["semaglutide"],"registrySourceId":"registry-NCT03548935-20260920","treatmentContext":"Subcutaneous semaglutide versus placebo, alongside lifestyle intervention.","primaryQuestion":"Percentage weight change and the proportion losing at least 5% of baseline weight at week 68.","interpretation":"The main report describes treatment-period outcomes in adults without diabetes. A separately appraised extension below follows selected participants after medication and structured lifestyle support stopped; it does not provide a randomized comparison of continuing versus stopping treatment.","relatedAnalysisIds":["analysis-NCT03548935-35441470-v1"],"evidenceState":"reviewed-results","anchor":"study-nct03548935","versionPath":"/studies/nct03548935/versions/2/","readingNotes":[],"reports":[{"peptideSlug":"semaglutide","reviewVersion":1,"studyHeading":"STEP 1 weight-management trial","studySha256":"5d5ea897d0ebc882d9e3bebdddcb308270e5ee9be012e950e9e1a0011618d18b","pmid":"33567185","reviewedAt":"2026-08-18","reviewVersionReviewedAt":"2026-08-18","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/semaglutide/synthesis/versions/1/","identityKey":"registry-NCT03548935-20260920:33567185","study":{"heading":"STEP 1 weight-management trial","sourceIds":["synthesis-pubmed-33567185-v1"],"design":{"text":"A double-blind, randomized, placebo-controlled trial followed participants for 68 weeks alongside a lifestyle intervention.","sourceIds":["synthesis-pubmed-33567185-v1"]},"population":{"text":"The trial enrolled 1,961 adults with obesity, or overweight plus at least one weight-related condition, who did not have diabetes.","sourceIds":["synthesis-pubmed-33567185-v1"]},"outcomes":{"text":"Mean body-weight change at 68 weeks was -14.9% in the semaglutide group and -2.4% with placebo. Gastrointestinal events were common, and treatment discontinuation for gastrointestinal events was more frequent with semaglutide.","sourceIds":["synthesis-pubmed-33567185-v1"]},"limitations":{"text":"The sponsor-funded trial combined treatment with lifestyle intervention, excluded people with diabetes, and does not by itself establish outcomes after treatment stops.","sourceIds":["synthesis-pubmed-33567185-v1"]}}}]},{"nctId":"NCT03574597","version":2,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"SELECT: cardiovascular outcomes","topic":"Cardiovascular outcomes","treatmentKind":"single","peptideSlugs":["semaglutide"],"registrySourceId":"registry-NCT03574597-20260920","treatmentContext":"Subcutaneous semaglutide versus placebo in people with established cardiovascular disease.","primaryQuestion":"Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke; the registry observation window extended to 240 weeks.","interpretation":"The report gives a mean follow-up of 39.8 months. That observed follow-up differs from the maximum registry observation window.","relatedAnalysisIds":["analysis-NCT03574597-38796653-v1","analysis-NCT03574597-38740993-v1"],"evidenceState":"reviewed-results","anchor":"study-nct03574597","versionPath":"/studies/nct03574597/versions/2/","readingNotes":[],"reports":[{"peptideSlug":"semaglutide","reviewVersion":1,"studyHeading":"SELECT cardiovascular-outcomes trial","studySha256":"32be3a2ef12e5a3805516178d4e5ea6c973185f72d368b555e532d78c7c212b5","pmid":"37952131","reviewedAt":"2026-08-18","reviewVersionReviewedAt":"2026-08-18","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/semaglutide/synthesis/versions/1/","identityKey":"registry-NCT03574597-20260920:37952131","study":{"heading":"SELECT cardiovascular-outcomes trial","sourceIds":["synthesis-pubmed-37952131-v1"],"design":{"text":"A multicenter, double-blind, randomized, placebo-controlled, event-driven superiority trial assessed a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.","sourceIds":["synthesis-pubmed-37952131-v1"]},"population":{"text":"The trial enrolled 17,604 adults age 45 or older with established cardiovascular disease and overweight or obesity, but no history of diabetes.","sourceIds":["synthesis-pubmed-37952131-v1"]},"outcomes":{"text":"A primary cardiovascular event occurred in 6.5% of the semaglutide group and 8.0% of the placebo group; the reported hazard ratio was 0.80. Permanent discontinuation because of adverse events occurred in 16.6% and 8.2%, respectively.","sourceIds":["synthesis-pubmed-37952131-v1"]},"limitations":{"text":"The sponsor-funded findings apply to people with preexisting cardiovascular disease and without diabetes; they do not answer primary prevention for lower-risk populations.","sourceIds":["synthesis-pubmed-37952131-v1"]}}}]},{"nctId":"NCT04881760","version":2,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Retatrutide: phase 2 obesity study","topic":"Weight management","treatmentKind":"single","peptideSlugs":["retatrutide"],"registrySourceId":"registry-NCT04881760-20260920","treatmentContext":"Retatrutide versus placebo in adults with overweight or obesity.","primaryQuestion":"Percentage change in body weight at week 24.","interpretation":"The often-cited 48-week weight results are secondary outcomes; the primary endpoint was measured at week 24.","relatedAnalysisIds":["analysis-NCT04881760-38858523-v1"],"evidenceState":"reviewed-results","anchor":"study-nct04881760","versionPath":"/studies/nct04881760/versions/2/","readingNotes":[],"reports":[{"peptideSlug":"retatrutide","reviewVersion":2,"studyHeading":"Phase 2 obesity trial","studySha256":"ce9999a3c4d535cd60a5033baa71a7991433eb84d3332248b7b692cef029617f","pmid":"37366315","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/retatrutide/synthesis/versions/2/","identityKey":"registry-NCT04881760-20260920:37366315","study":{"heading":"Phase 2 obesity trial","sourceIds":["synthesis-pubmed-37366315-v2"],"design":{"text":"A double-blind, randomized, placebo-controlled Phase 2 trial followed participants for 48 weeks and assessed body-weight change and safety.","sourceIds":["synthesis-pubmed-37366315-v2"]},"population":{"text":"The trial enrolled 338 adults with obesity, or overweight plus at least one weight-related condition.","sourceIds":["synthesis-pubmed-37366315-v2"]},"outcomes":{"text":"At 48 weeks, reported mean body-weight change ranged from -8.7% to -24.2% across retatrutide groups, compared with -2.1% for placebo. Gastrointestinal events were the most common adverse events, and heart-rate increases peaked at 24 weeks before declining.","sourceIds":["synthesis-pubmed-37366315-v2"]},"limitations":{"text":"This was a sponsor-funded Phase 2 trial with 48-week follow-up; it was not a long-term cardiovascular-outcomes or rare-harms study.","sourceIds":["synthesis-pubmed-37366315-v2"]}}}]},{"nctId":"NCT03323749","version":2,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"MMPOWER-3: mitochondrial myopathy","topic":"Rare disease","treatmentKind":"single","peptideSlugs":["elamipretide"],"registrySourceId":"registry-NCT03323749-20260920","treatmentContext":"Elamipretide versus placebo in people with primary mitochondrial myopathy.","primaryQuestion":"Change in six-minute walking distance and symptom-assessment total fatigue score at week 24.","interpretation":"Neither primary endpoint was met. Findings in primary mitochondrial myopathy should not be substituted for evidence in Barth syndrome.","relatedAnalysisIds":["analysis-NCT03323749-39574155-v1"],"evidenceState":"reviewed-results","anchor":"study-nct03323749","versionPath":"/studies/nct03323749/versions/2/","readingNotes":[{"heading":"Overall result versus exploratory subgroup","text":"The full text reports neither primary endpoint was met in the overall population. Its genetic subgroup analyses are exploratory, and the nuclear-DNA subgroup result is identified as post hoc; it cannot replace the overall primary result.","sourceId":"fulltext-PMC10382259-20260920","sectionIds":["s1-5-1","s2-2-1","s2-2-2","s3"]},{"heading":"An abstract and full-text discrepancy","text":"The indexed abstract and the full-text primary-results section give different confidence intervals and p values for the fatigue comparison. Both describe a nonsignificant result. We retain that shared conclusion without selecting one conflicting numerical estimate as definitive.","sourceId":"fulltext-PMC10382259-20260920","sectionIds":["s2-2-1"]}],"reports":[{"peptideSlug":"elamipretide","reviewVersion":1,"studyHeading":"MMPOWER-3: primary mitochondrial myopathy","studySha256":"2de652c40b1ee4c2c3460db3932fbf57d1d3f89056ef15f51e4d2087b3d09307","pmid":"37268435","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/elamipretide/synthesis/versions/1/","identityKey":"registry-NCT03323749-20260920:37268435","study":{"heading":"MMPOWER-3: primary mitochondrial myopathy","sourceIds":["synthesis-pubmed-37268435-v1"],"design":{"text":"A randomized, blinded, placebo-controlled phase 3 trial assessed 24-week outcomes.","sourceIds":["synthesis-pubmed-37268435-v1"]},"population":{"text":"The study randomized 218 participants with genetically confirmed primary mitochondrial myopathy.","sourceIds":["synthesis-pubmed-37268435-v1"]},"outcomes":{"text":"Neither walking distance nor fatigue met the primary efficacy endpoint. Most reported adverse events were mild or moderate.","sourceIds":["synthesis-pubmed-37268435-v1"]},"limitations":{"text":"This is a different disease population from Barth syndrome. Overall null results cannot be replaced by favorable exploratory subgroup findings.","sourceIds":["synthesis-pubmed-37268435-v1"]}}}]},{"nctId":"NCT04026113","version":2,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Linaclotide: pediatric functional constipation","topic":"Gastroenterology","treatmentKind":"single","peptideSlugs":["linaclotide"],"registrySourceId":"registry-NCT04026113-20260920","treatmentContext":"Linaclotide versus placebo in the functional-constipation cohort of a pediatric trial.","primaryQuestion":"For functional constipation, change in weekly spontaneous bowel-movement frequency over 12 weeks; the registry has a separate primary endpoint for its IBS-C cohort.","interpretation":"The registry covers 438 participants across two conditions. This report concerns 330 randomized children with functional constipation, of whom 328 received treatment.","relatedAnalysisIds":["analysis-NCT04026113-41913506-v1"],"evidenceState":"reviewed-results","anchor":"study-nct04026113","versionPath":"/studies/nct04026113/versions/2/","readingNotes":[],"reports":[{"peptideSlug":"linaclotide","reviewVersion":1,"studyHeading":"Pediatric functional constipation","studySha256":"cc2b8e139045f1a14098da63d83d679f44a3c42ffc575bacb45b46e4b0712e81","pmid":"38211604","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/linaclotide/synthesis/versions/1/","identityKey":"registry-NCT04026113-20260920:38211604","study":{"heading":"Pediatric functional constipation","sourceIds":["synthesis-pubmed-38211604-v1"],"design":{"text":"Randomized, double-blind, placebo-controlled phase 3 trial lasting 12 weeks.","sourceIds":["synthesis-pubmed-38211604-v1"]},"population":{"text":"330 children aged 6–17 years were randomized; 328 received treatment and 293 completed.","sourceIds":["synthesis-pubmed-38211604-v1"]},"outcomes":{"text":"The adjusted between-group difference was 1.17 additional spontaneous bowel movements per week. Diarrhea occurred in seven of 164 active-group and three of 164 placebo participants; one active-group participant required hospitalization for dehydration.","sourceIds":["synthesis-pubmed-38211604-v1"]},"limitations":{"text":"The trial addresses functional constipation in the enrolled age range. Its findings cannot establish safety in younger children or replace age-specific label warnings.","sourceIds":["synthesis-pubmed-38211604-v1"]}}}]},{"nctId":"NCT04184622","version":2,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"SURMOUNT-1: weight change without diabetes","topic":"Weight management","treatmentKind":"single","peptideSlugs":["tirzepatide"],"registrySourceId":"registry-NCT04184622-20260920","treatmentContext":"Tirzepatide versus placebo in adults with overweight or obesity, excluding diabetes.","primaryQuestion":"Percentage weight change and the proportion losing at least 5% of baseline weight at week 72.","interpretation":"The main report concerns adults without diabetes and its 72-week weight endpoints. Separately appraised publications below examine patient-reported outcomes and exploratory physical-function subgroups from the same trial.","relatedAnalysisIds":["analysis-NCT04184622-39497468-v1","analysis-NCT04184622-41187013-v1","analysis-NCT04184622-39800653-v1","analysis-NCT04184622-40677091-v1"],"evidenceState":"reviewed-results","anchor":"study-nct04184622","versionPath":"/studies/nct04184622/versions/2/","readingNotes":[],"reports":[{"peptideSlug":"tirzepatide","reviewVersion":1,"studyHeading":"SURMOUNT-1 obesity trial","studySha256":"966c32f6ed353c6dc0a143a932ceeda578ef6707cad5098d9adc6df7365485a0","pmid":"35658024","reviewedAt":"2026-08-19","reviewVersionReviewedAt":"2026-08-19","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/tirzepatide/synthesis/versions/1/","identityKey":"registry-NCT04184622-20260920:35658024","study":{"heading":"SURMOUNT-1 obesity trial","sourceIds":["synthesis-pubmed-35658024-v1"],"design":{"text":"A double-blind, randomized, placebo-controlled Phase 3 trial assessed body-weight change over 72 weeks.","sourceIds":["synthesis-pubmed-35658024-v1"]},"population":{"text":"The trial randomized 2,539 adults with obesity, or overweight plus at least one weight-related complication, and excluded people with diabetes.","sourceIds":["synthesis-pubmed-35658024-v1"]},"outcomes":{"text":"Reported mean body-weight change at week 72 ranged from -15.0% to -20.9% across tirzepatide groups and was -3.1% with placebo. Gastrointestinal events were the most common adverse events, and discontinuation for adverse events was more frequent in the tirzepatide groups.","sourceIds":["synthesis-pubmed-35658024-v1"]},"limitations":{"text":"The sponsor-funded trial used a dose-escalation period, excluded diabetes, and does not by itself establish outcomes after treatment stops or uncommon harms over longer periods.","sourceIds":["synthesis-pubmed-35658024-v1"]}}}]},{"nctId":"NCT03098797","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"TAZPOWER: controlled trial and open follow-up","topic":"Rare disease","treatmentKind":"single","peptideSlugs":["elamipretide"],"registrySourceId":"registry-NCT03098797-20260920","treatmentContext":"Elamipretide versus placebo in a crossover study of people with genetically confirmed Barth syndrome, followed by open-label treatment.","primaryQuestion":"Six-minute walking distance and total fatigue score during the controlled 12-week treatment periods.","interpretation":"The controlled phase did not meet either primary endpoint. Later open-label improvements come from a smaller group without a concurrent placebo comparison.","evidenceState":"reviewed-results","anchor":"study-nct03098797","versionPath":"/studies/nct03098797/versions/1/","readingNotes":[{"heading":"One cohort, two different phases","text":"Twelve participants completed both controlled treatment periods. Ten entered the open-label extension, and eight contributed measurements at extension week 36; two discontinued because of injection-site reactions. These are nested populations, not independent trials.","sourceId":"fulltext-PMC7935714-20260920","sectionIds":["Sec10","Sec11","Sec12"]},{"heading":"The extension changes the main question","text":"The full text identifies walking distance and fatigue as primary outcomes of the controlled phase. Long-term safety and tolerability were primary in the extension; functional measures were secondary. Open-label changes cannot replace the negative controlled comparison.","sourceId":"fulltext-PMC7935714-20260920","sectionIds":["Sec7","Sec11","Sec12","Sec16"]}],"reports":[{"peptideSlug":"elamipretide","reviewVersion":1,"studyHeading":"TAZPOWER: randomized and early extension results","studySha256":"446a22fc39bbbc338ce7da31c41c7c492bf411f73326ee3c949560a70f60d06e","pmid":"33077895","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/elamipretide/synthesis/versions/1/","identityKey":"registry-NCT03098797-20260920:33077895","study":{"heading":"TAZPOWER: randomized and early extension results","sourceIds":["synthesis-pubmed-33077895-v1"],"design":{"text":"A blinded placebo-controlled crossover trial was followed by an open-label extension.","sourceIds":["synthesis-pubmed-33077895-v1"]},"population":{"text":"Twelve participants with Barth syndrome entered the randomized study; ten entered the extension and eight reached 36 weeks.","sourceIds":["synthesis-pubmed-33077895-v1"]},"outcomes":{"text":"Neither primary endpoint was met in the randomized period. Walking distance and reported fatigue improved during the uncontrolled extension.","sourceIds":["synthesis-pubmed-33077895-v1"]},"limitations":{"text":"The extension lacks a concurrent placebo group and has attrition. Its changes cannot be interpreted as another randomized treatment effect; the abstract does not provide a detailed harms assessment.","sourceIds":["synthesis-pubmed-33077895-v1"]}}}]},{"nctId":"NCT02171130","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Nasal glucagon: caregiver use outside the clinic","topic":"Diabetes","treatmentKind":"single","peptideSlugs":["glucagon"],"registrySourceId":"registry-NCT02171130-20260920","treatmentContext":"A single-group study of nasal glucagon administered by trained caregivers during moderate or severe hypoglycemic episodes in adults with type 1 diabetes.","primaryQuestion":"The proportion of participants awakening or returning to their normal status within 30 minutes, assessed by their caregivers.","interpretation":"This uncontrolled study uses both patient-level and event-level outcomes. The efficacy analysis excluded events requiring other treatment before a response; its response percentage is not an all-treated success rate.","evidenceState":"reviewed-results","anchor":"study-nct02171130","versionPath":"/studies/nct02171130/versions/1/","readingNotes":[{"heading":"Repeated events are not additional people","text":"Of 129 enrolled participants, 87 received treatment, 74 entered the main safety analysis and 69 entered the efficacy analysis. The latter contributed 157 evaluable events, including repeated events in the same people.","sourceId":"fulltext-PMC5947579-20260920","sectionIds":["dom13278-sec-0002","dom13278-sec-0003"]},{"heading":"Keep the outcome denominator visible","text":"The report describes recovery within 30 minutes in 151 of 157 evaluable events. At the patient level, 66 of 69 recovered in at least one evaluable event and 64 of 69 in every evaluable event. Events needing additional treatment before response were excluded from this analysis.","sourceId":"fulltext-PMC5947579-20260920","sectionIds":["dom13278-sec-0002","dom13278-sec-0004"]}],"reports":[{"peptideSlug":"glucagon","reviewVersion":2,"studyHeading":"Nasal glucagon during spontaneous episodes","studySha256":"2534d9f7b7fb6d6c111b40a9105229480fb0b0b6a7e7a1ba65aa2dea460ce2f9","pmid":"29504662","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/glucagon/synthesis/versions/2/","identityKey":"registry-NCT02171130-20260920:29504662","study":{"heading":"Nasal glucagon during spontaneous episodes","sourceIds":["synthesis-pubmed-29504662-v2"],"design":{"text":"Prospective open-label real-world study with trained caregivers and no randomized comparator.","sourceIds":["synthesis-pubmed-29504662-v2"]},"population":{"text":"69 adults experienced 157 evaluable moderate or severe hypoglycemia episodes.","sourceIds":["synthesis-pubmed-29504662-v2"]},"outcomes":{"text":"Caregivers reported resolution within 30 minutes in 95.7% of patients. All 12 severe episodes resolved within 15 minutes.","sourceIds":["synthesis-pubmed-29504662-v2"]},"limitations":{"text":"Repeated episodes within people are not independent participants. Caregiver assessment, training and lack of a comparator limit causal and comparative conclusions.","sourceIds":["synthesis-pubmed-29504662-v2"]}}}]},{"nctId":"NCT02333071","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Bremelanotide: RECONNECT study 301","topic":"Sexual health","treatmentKind":"single","peptideSlugs":["bremelanotide"],"registrySourceId":"registry-NCT02333071-20260920","treatmentContext":"Bremelanotide versus placebo in premenopausal women with acquired, generalized hypoactive sexual desire disorder.","primaryQuestion":"Changes in the Female Sexual Function Index desire score and the Female Sexual Distress Scale item concerning distress about low desire; the registry includes the core study and extension observation periods.","interpretation":"The selected report concerns the 24-week blinded core study. It reports improvement in both primary scales; the prespecified secondary count of satisfying sexual events did not differ significantly.","evidenceState":"reviewed-results","anchor":"study-nct02333071","versionPath":"/studies/nct02333071/versions/1/","readingNotes":[{"heading":"Use this trial’s analysis population","text":"Study 301 included 643 participants in its safety population and 630 in its modified intention-to-treat efficacy population. The paper’s 1,267 randomized participants combine both trials; registry enrollment is also a different denominator.","sourceId":"fulltext-PMC6819021-20260920","sectionIds":["s2","s3"]},{"heading":"A favorable post hoc measure does not replace the failed endpoint","text":"The prespecified count of satisfying sexual events did not differ significantly between groups. Subsequent ranked endpoints therefore became exploratory. The later favorable percentage of encounters that were satisfying was a separate post hoc analysis.","sourceId":"fulltext-PMC6819021-20260920","sectionIds":["s2","s3"]},{"heading":"Withdrawal and missing observations matter","text":"The primary analysis carried the last observation forward. Study 301 withdrawal was 41.9% versus 16.0% for bremelanotide and placebo. The paper’s predominantly white US population and its exclusions limit generalization.","sourceId":"fulltext-PMC6819021-20260920","sectionIds":["s2","s3","s4"]}],"reports":[{"peptideSlug":"bremelanotide","reviewVersion":2,"studyHeading":"RECONNECT: study 301","studySha256":"b1e0abd6ff4707bbb2bf1ee35c32245a2723cb072d801998f78e19e0beeff78b","pmid":"31599840","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/bremelanotide/synthesis/versions/2/","identityKey":"registry-NCT02333071-20260920:31599840","study":{"heading":"RECONNECT: study 301","sourceIds":["synthesis-pubmed-31599840-v2"],"design":{"text":"A randomized, double-blind, placebo-controlled trial assessed changes in desire and related distress during a 24-week treatment period.","sourceIds":["synthesis-pubmed-31599840-v2"]},"population":{"text":"Premenopausal women with hypoactive sexual desire disorder participated. The abstract reports 1,267 randomized participants across both RECONNECT trials, not a separate study 301 total.","sourceIds":["synthesis-pubmed-31599840-v2"]},"outcomes":{"text":"Compared with placebo, the reported treatment differences were +0.30 points on the desire measure and −0.37 points on the related-distress measure.","sourceIds":["synthesis-pubmed-31599840-v2"]},"limitations":{"text":"These are study 301 results from the selected abstract. Its combined trial totals and integrated effect estimates must not be assigned to this trial alone. Nausea, flushing and headache were more frequent with bremelanotide in both trials.","sourceIds":["synthesis-pubmed-31599840-v2"]}}}]},{"nctId":"NCT02338960","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Bremelanotide: RECONNECT study 302","topic":"Sexual health","treatmentKind":"single","peptideSlugs":["bremelanotide"],"registrySourceId":"registry-NCT02338960-20260920","treatmentContext":"Bremelanotide versus placebo in premenopausal women with acquired, generalized hypoactive sexual desire disorder.","primaryQuestion":"Changes in the Female Sexual Function Index desire score and the Female Sexual Distress Scale item concerning distress about low desire; the registry includes the core study and extension observation periods.","interpretation":"The selected report concerns the 24-week blinded core study. It reports improvement in both primary scales; the prespecified secondary count of satisfying sexual events did not differ significantly.","evidenceState":"reviewed-results","anchor":"study-nct02338960","versionPath":"/studies/nct02338960/versions/1/","readingNotes":[{"heading":"Use this trial’s analysis population","text":"Study 302 included 604 participants in its safety population and 572 in its modified intention-to-treat efficacy population. The paper’s 1,267 randomized participants combine both trials; registry enrollment is also a different denominator.","sourceId":"fulltext-PMC6819021-20260920","sectionIds":["s2","s3"]},{"heading":"A favorable post hoc measure does not replace the failed endpoint","text":"The prespecified count of satisfying sexual events did not differ significantly between groups. Subsequent ranked endpoints therefore became exploratory. The later favorable percentage of encounters that were satisfying was a separate post hoc analysis.","sourceId":"fulltext-PMC6819021-20260920","sectionIds":["s2","s3"]},{"heading":"Withdrawal and missing observations matter","text":"The primary analysis carried the last observation forward. Study 302 withdrawal was 43.8% versus 28.4% for bremelanotide and placebo. The paper’s predominantly white US population and its exclusions limit generalization.","sourceId":"fulltext-PMC6819021-20260920","sectionIds":["s2","s3","s4"]}],"reports":[{"peptideSlug":"bremelanotide","reviewVersion":2,"studyHeading":"RECONNECT: study 302","studySha256":"9d4146c1daf406e4aaf10364f1d1c9d5873ba51fcf769d32a3ee498659344499","pmid":"31599840","reviewedAt":"2026-09-20","reviewVersionReviewedAt":"2026-09-20","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/bremelanotide/synthesis/versions/2/","identityKey":"registry-NCT02338960-20260920:31599840","study":{"heading":"RECONNECT: study 302","sourceIds":["synthesis-pubmed-31599840-v2"],"design":{"text":"A randomized, double-blind, placebo-controlled trial assessed changes in desire and related distress during a 24-week treatment period.","sourceIds":["synthesis-pubmed-31599840-v2"]},"population":{"text":"Premenopausal women with hypoactive sexual desire disorder participated. The abstract reports 1,267 randomized participants across both RECONNECT trials, not a separate study 302 total.","sourceIds":["synthesis-pubmed-31599840-v2"]},"outcomes":{"text":"Compared with placebo, the reported treatment differences were +0.42 points on the desire measure and −0.29 points on the related-distress measure.","sourceIds":["synthesis-pubmed-31599840-v2"]},"limitations":{"text":"These are study 302 results from the selected abstract. Its combined trial totals and integrated effect estimates must not be assigned to this trial alone. Nausea, flushing and headache were more frequent with bremelanotide in both trials.","sourceIds":["synthesis-pubmed-31599840-v2"]}}}]},{"nctId":"NCT00842348","version":1,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"Lanreotide: CLARINET open-label extension","topic":"Oncology","treatmentKind":"follow-up","peptideSlugs":["lanreotide"],"registrySourceId":"registry-NCT00842348-20260920","treatmentContext":"Open-label lanreotide in eligible participants from the CLARINET core trial, including people previously assigned placebo.","primaryQuestion":"Adverse events throughout the extension; the registry identifies safety as the primary outcome.","interpretation":"The reported 38.5-month progression-free survival starts at core-trial randomization, not extension entry. Extension entrants were selected and all received active treatment, so this is not a new randomized long-term comparison.","extensionOf":{"nctId":"NCT00353496","version":1,"sourceId":"fulltext-PMC7881960-20260920","sectionIds":["Sec3","Sec4"],"text":"This extension follows eligible participants from the original CLARINET cohort. It has a separate registration but an overlapping population."},"evidenceState":"reviewed-results","anchor":"study-nct00842348","versionPath":"/studies/nct00842348/versions/1/","readingNotes":[{"heading":"Different questions use different populations","text":"The extension safety population contained 89 participants: 42 previously assigned lanreotide and 47 placebo. The efficacy analysis retained all participants randomized in the core trial, even if they did not enter the extension; its original groups were 101 and 103.","sourceId":"fulltext-PMC7881960-20260920","sectionIds":["Sec8","Sec11","Sec13"]},{"heading":"The survival clock starts in the core trial","text":"Progression-free survival used time from core randomization to progression or death, appending extension follow-up. The 38.5-month median is not an estimate beginning at extension entry. The paper approximates a month as four weeks.","sourceId":"fulltext-PMC7881960-20260920","sectionIds":["Sec6","Sec9","Sec13"]},{"heading":"Selection and source revisions remain relevant","text":"A post hoc sensitivity analysis addressed eligible core-study completers who did not enter the extension. The paper also states that one core placebo progression event had previously been misclassified and was included in this later analysis. Earlier source versions remain separately attributed.","sourceId":"fulltext-PMC7881960-20260920","sectionIds":["Sec9","Sec13"]}],"reports":[{"peptideSlug":"lanreotide","reviewVersion":1,"studyHeading":"CLARINET open-label extension","studySha256":"17c466bd5d609bdb1a76921da2ca2f4e8f59b6a4bf60a9c6efd734751d9558d7","pmid":"33052555","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/lanreotide/synthesis/versions/1/","identityKey":"registry-NCT00842348-20260920:33052555","study":{"heading":"CLARINET open-label extension","sourceIds":["synthesis-pubmed-33052555-v1"],"design":{"text":"Eligible original-trial participants entered an extension in which everyone received lanreotide.","sourceIds":["synthesis-pubmed-33052555-v1"]},"population":{"text":"89 participants entered: 42 previously assigned lanreotide and 47 previously assigned placebo.","sourceIds":["synthesis-pubmed-33052555-v1"]},"outcomes":{"text":"The continuous-treatment group had a reported median progression-free survival of 38.5 months. Adverse-event incidence was lower during extension than during the core study.","sourceIds":["synthesis-pubmed-33052555-v1"]},"limitations":{"text":"Selective extension enrollment, crossover and absence of a concurrent placebo group prevent an independent randomized long-term comparison.","sourceIds":["synthesis-pubmed-33052555-v1"]}}}]},{"nctId":"NCT01394952","version":2,"publishedAt":"2026-09-20","reviewedAt":"2026-09-20","title":"REWIND: cardiovascular outcomes","topic":"Cardiovascular outcomes","treatmentKind":"single","peptideSlugs":["dulaglutide"],"registrySourceId":"registry-NCT01394952-20260920","treatmentContext":"Dulaglutide versus placebo in people with type 2 diabetes and cardiovascular disease or risk factors.","primaryQuestion":"Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke.","interpretation":"The reported median follow-up was 5.4 years. The composite result does not establish benefit for every component, and all-cause mortality did not differ significantly.","relatedAnalysisIds":["analysis-NCT01394952-41988866-v1"],"evidenceState":"reviewed-results","anchor":"study-nct01394952","versionPath":"/studies/nct01394952/versions/2/","readingNotes":[],"reports":[{"peptideSlug":"dulaglutide","reviewVersion":1,"studyHeading":"REWIND: cardiovascular outcomes","studySha256":"6c12501b39e471fc8cfd5c4c9b0c57fce9b6d1206d75480fb2ba6b8f07a9e7b7","pmid":"31189511","reviewedAt":"2026-09-15","reviewVersionReviewedAt":"2026-09-15","reviewSurface":"abstract-and-record-metadata","reviewPath":"/peptides/dulaglutide/synthesis/versions/1/","identityKey":"registry-NCT01394952-20260920:31189511","study":{"heading":"REWIND: cardiovascular outcomes","sourceIds":["synthesis-pubmed-31189511-v1"],"design":{"text":"A blinded randomized placebo-controlled trial followed participants for a median of 5.4 years.","sourceIds":["synthesis-pubmed-31189511-v1"]},"population":{"text":"The trial enrolled 9,901 adults aged at least 50 with type 2 diabetes and cardiovascular disease or risk factors.","sourceIds":["synthesis-pubmed-31189511-v1"]},"outcomes":{"text":"The primary cardiovascular composite occurred in 12.0% with dulaglutide versus 13.4% with placebo (hazard ratio 0.88; 95% CI 0.79–0.99). Gastrointestinal adverse events were more frequent with dulaglutide.","sourceIds":["synthesis-pubmed-31189511-v1"]},"limitations":{"text":"The composite combines different outcomes and does not imply improvement in every component. All-cause mortality was not significantly different; these results do not establish effects in people without type 2 diabetes.","sourceIds":["synthesis-pubmed-31189511-v1"]}}}]}]}