Explore 62 selected studies across 27 peptide profiles. See what was tested, what the reports found, and what the findings can explain.
Each card follows one registered study. Published findings and registry plans are shown separately; a combination or follow-up study keeps that context visible. This is a selected, manually linked collection rather than a complete list of human studies.
Alendronate after prior abaloparatide or placebo treatment in eligible ACTIVE completers. ↗
Registered primary question: New vertebral fractures measured from the parent-study baseline through the first six extension months. ↗
What the reviewed report found
Journal year 2018 · Article summary reviewed 2026-09-14
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.↗
Keep in context: The registry primary window ends at cumulative month 25; this later report follows the treatment sequence through month 43. Both extension groups received alendronate. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Who entered the extension
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. Full text ↗ · Indexed abstract ↗
Sections: ACTIVExtend inclusion and exclusion criteria.
Which follow-up is being counted
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. Full text ↗ · Indexed abstract ↗
Registry source ↗ · Updated 2020-12-11; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
ACTIVExtend: follow-up of ACTIVE participants
Design in the report
An extension followed eligible ACTIVE completers, with both groups subsequently receiving alendronate. It did not randomly assign a new independent cohort.↗
Participants in the report
The extension enrolled 558 women from the former abaloparatide group and 581 from the former placebo group.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 51fc75294fea4226f28c808cc56c3c080dd2f93566024ac54781a310f76855d7. Section identifiers and hashes are included in the cited study data.
Abaloparatide versus placebo in men with osteoporosis. ↗
Registered primary question: Percentage change in lumbar-spine bone mineral density at month 12. ↗
What the reviewed report found
Journal year 2022 · Article summary reviewed 2026-09-14
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.↗
Keep in context: The primary outcome was bone density. The selected report does not establish a reduction in fractures in this population. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
What the study could measure
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. Full text ↗ · Indexed abstract ↗
Registry source ↗ · Updated 2023-04-07; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
ATOM: bone-density outcomes in men
Design in the report
A 12-month randomized placebo-controlled trial used change in lumbar-spine bone mineral density as its primary endpoint.↗
Participants in the report
A total of 228 men with osteoporosis were randomized: 149 to abaloparatide and 79 to placebo.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in the article abstract indexed in PubMed. No matching reference is declared in this registry snapshot. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 7e13c964871e3a13603c3b5add661d412019f247a8c703963f3645554c7d12fa. Section identifiers and hashes are included in the cited study data.
Lixisenatide versus placebo added to usual care after a recent acute coronary event in people with type 2 diabetes. ↗
Registered primary question: Time to cardiovascular death, nonfatal heart attack, nonfatal stroke or hospitalization for unstable angina. ↗
What the reviewed report found
Journal year 2015 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
6,068 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Triple
Design
Parallel
Eligible ages
30 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2016-12-20; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
ELIXA: cardiovascular outcomes
Design in the report
Randomized placebo-controlled trial added lixisenatide or placebo to usual care.↗
Participants in the report
6,068 people with type 2 diabetes and a recent acute coronary event were followed for a median of 25 months.↗
Limitations
The result is a cardiovascular safety comparison in a high-risk population, not evidence of cardiovascular benefit or the entire glycemic-efficacy program.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Extended-release exenatide versus placebo alongside usual care in people with type 2 diabetes. ↗
Registered primary question: Time to the first major cardiovascular event, tested for both safety noninferiority and efficacy superiority. ↗
What the reviewed report found
Journal year 2017 · Article summary reviewed 2026-08-19
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.↗
Keep in context: The safety noninferiority criterion was met, but the superiority criterion for reducing cardiovascular events was not. Those are different questions. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
14,752 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Triple
Design
Parallel
Eligible ages
18 Years to 130 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2018-08-08; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
EXSCEL cardiovascular-outcomes trial
Design in the report
A sponsor-funded randomized placebo-controlled cardiovascular-outcomes trial followed participants for a median of 3.2 years alongside usual care.↗
Participants in the report
The trial randomized 14,752 adults with type 2 diabetes; 73.1% had previous cardiovascular disease.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Liraglutide versus placebo added to standard care in people with type 2 diabetes and high cardiovascular risk. ↗
Registered primary question: Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke. ↗
What the reviewed report found
Journal year 2016 · Article summary reviewed 2026-08-19
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
9,341 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
50 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2019-07-17; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
LEADER cardiovascular-outcomes trial
Design in the report
A double-blind, randomized, placebo-controlled cardiovascular-outcomes trial followed participants for a median of 3.8 years.↗
Participants in the report
The trial randomized 9,340 adults with type 2 diabetes and high cardiovascular risk in addition to standard care.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Dulaglutide versus placebo in people with type 2 diabetes and cardiovascular disease or risk factors. ↗
Registered primary question: Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke. ↗
What the reviewed report found
Journal year 2019 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Related analyses from this study (1)
These publications examine participants from the study above. They do not add independent trials.
Post hoc analysis · Journal year 2026 · Full-text reading reviewed 2026-09-20
REWIND: exploratory neurodegeneration biomarkers
How it relates: This post hoc biomarker analysis reuses REWIND participants; it is not a separate dementia-treatment trial. ↗
Question: Did dulaglutide affect two-year blood biomarker changes, and did baseline biomarker groups differ in subsequent cognitive-test outcomes? ↗
Participants: 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. ↗
Reported findings: 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. ↗
Limits of this analysis: 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. ↗
Registry source ↗ · Updated 2019-10-08; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
REWIND: cardiovascular outcomes
Design in the report
A blinded randomized placebo-controlled trial followed participants for a median of 5.4 years.↗
Participants in the report
The trial enrolled 9,901 adults aged at least 50 with type 2 diabetes and cardiovascular disease or risk factors.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Subcutaneous semaglutide versus placebo in people with established cardiovascular disease. ↗
Registered primary question: Time to the first cardiovascular death, nonfatal heart attack or nonfatal stroke; the registry observation window extended to 240 weeks. ↗
What the reviewed report found
Journal year 2023 · Article summary reviewed 2026-08-18
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.↗
Keep in context: The report gives a mean follow-up of 39.8 months. That observed follow-up differs from the maximum registry observation window. ↗↗
Related analyses from this study (2)
These publications examine participants from the study above. They do not add independent trials.
How it relates: A prespecified secondary analysis of the SELECT cardiovascular-outcomes trial, using the same randomized participants. ↗
Question: Did semaglutide affect a five-component kidney endpoint, including kidney death, replacement therapy, sustained filtration decline and persistent macroalbuminuria? ↗
Participants: SELECT randomized 17,604 adults with overweight or obesity and established cardiovascular disease, without diabetes. This publication does not add another independent study population. ↗
Reported findings: 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. ↗
Limits of this analysis: 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. ↗
How it relates: A secondary report of weight and body measurements from the SELECT cardiovascular-outcomes trial, using the same randomized population. ↗
Question: How did weight and waist measurements change during trial follow-up, including observations through week 208? ↗
Participants: 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. ↗
Reported findings: 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. ↗
Limits of this analysis: 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. ↗
Registry source ↗ · Updated 2024-08-30; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
SELECT cardiovascular-outcomes trial
Design in the report
A multicenter, double-blind, randomized, placebo-controlled, event-driven superiority trial assessed a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.↗
Participants in the report
The trial enrolled 17,604 adults age 45 or older with established cardiovascular disease and overweight or obesity, but no history of diabetes.↗
Limitations
The sponsor-funded findings apply to people with preexisting cardiovascular disease and without diabetes; they do not answer primary prevention for lower-risk populations.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
A single subcutaneous exposure to zenagamtide, formerly amycretin, in groups with differing renal function; no placebo group. ↗
Registered primary question: Total drug exposure, measured as area under the concentration-time curve from time zero to infinity, using samples collected through day 28. ↗
What the reviewed report found
Journal year 2026 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Exposure differences need interpretation
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. Full text ↗ · Indexed abstract ↗
Sections: Endpoints and Statistical Analysis; Pharmacokinetics; Discussion.
A short observation in small groups
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. Full text ↗ · Indexed abstract ↗
Sections: Results; Safety; Discussion.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
42 · reported actual
Registry status
Completed
Allocation and masking
Non randomized · Open label
Design
Parallel
Eligible ages
18 Years to 80 Years
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2025-03-30; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Renal-function pharmacokinetic study
Design in the report
A single-exposure study compared pharmacokinetics across renal-function groups with four weeks of follow-up, registered as NCT06559527.↗
Participants in the report
Forty-two adults participated: 14 with normal renal function and seven each with mild, moderate or severe impairment or end-stage renal disease.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 846ff8cc4fd376b6c09ad3bdbd69c7749f60d40fecc9caababfff8f7d1dce76f. Section identifiers and hashes are included in the cited study data.
Dulaglutide versus insulin glargine as basal therapy, with insulin lispro in all groups. ↗
Registered primary question: Change in HbA1c at week 26. ↗
What the reviewed report found
Journal year 2018 · Article summary reviewed 2026-09-15
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.↗
Keep in context: The study continued for 52 weeks, but the primary comparison was glycemic control at week 26. Kidney measurements were secondary outcomes. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
577 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Open label
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2019-09-19; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
AWARD-7: diabetes with chronic kidney disease
Design in the report
An open-label randomized trial compared dulaglutide with insulin glargine, with insulin lispro in all groups, over 52 weeks.↗
Participants in the report
The study randomized 577 adults with type 2 diabetes and stage 3–4 chronic kidney disease.↗
Limitations
Kidney measures were secondary outcomes. This trial cannot establish a general prevention claim for kidney failure or isolate the effects of background insulin treatment.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Dulaglutide versus placebo in youths with type 2 diabetes, followed by an open-label extension. ↗
Registered primary question: Change in HbA1c at week 26, pooling the dulaglutide groups. ↗
What the reviewed report found
Journal year 2022 · Article summary reviewed 2026-09-15
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.↗
Keep in context: The placebo-controlled comparison lasted 26 weeks; participants originally receiving placebo then received dulaglutide. The later extension is not another concurrent placebo comparison. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
154 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
10 Years to 17 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2022-07-01; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
AWARD-PEDS: glycemic control in youths
Design in the report
A blinded randomized placebo-controlled study evaluated a 26-week primary endpoint, followed by an open-label extension.↗
Participants in the report
The trial randomized 154 participants aged 10 to under 18 with type 2 diabetes.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Nasal versus intramuscular glucagon during controlled insulin-induced hypoglycemia in adults with type 1 diabetes. ↗
Registered primary question: The proportion meeting the prespecified glucose-recovery criterion within 30 minutes after administration, without additional intervention. ↗
What the reviewed report found
Journal year 2020 · Article summary reviewed 2026-09-20
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.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
The success rate uses an evaluable subset
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. Full text ↗ · Indexed abstract ↗
Sections: Demographics and Disposition; Efficacy.
Laboratory timing is not emergency performance
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. Full text ↗ · Indexed abstract ↗
Sections: Discussion.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
70 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Open label
Design
Crossover
Eligible ages
18 Years to 64 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2019-09-23; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Nasal versus intramuscular glucagon
Design in the report
Randomized crossover noninferiority study after experimentally induced hypoglycemia.↗
Participants in the report
The primary efficacy analysis included 66 adults with type 1 diabetes who received both formulations.↗
Limitations
The induced-hypoglycemia setting and controlled administration differ from an unplanned emergency. Recovery speed is distinct from preparation time and caregiver usability.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 613f1e42568902583950d2c770c4f35e0aadad13e63a1a2dd7aa1aa631f7575b. Section identifiers and hashes are included in the cited study data.
Mazdutide compared with dulaglutide in Chinese adults with type 2 diabetes inadequately controlled on oral glucose-lowering medicines. ↗
Registered primary question: Change in HbA1c from baseline to week 28. ↗
What the reviewed report found
Journal year 2026 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
731 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2024-08-23; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Type 2 diabetes: active comparator
Design in the report
Randomized phase 3 comparison with a specified dulaglutide regimen over 28 weeks.↗
Participants in the report
731 adults in China with type 2 diabetes participated.↗
Limitations
The comparison is specific to the tested regimens and population, not a ranking against all uses of the comparator or other medicines.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
A Study of IBI362 in Participants With Type 2 Diabetes ↗ Protocol identifier: CIBI362A302. Sponsor: Innovent Biologics (Suzhou) Co. Ltd.. Retrieved 2026-09-20; SHA-256 dd46d03b252f91f335957eb43059b48d1ef1417ba193870ccb86760106aec69b.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
A single-group study of nasal glucagon administered by trained caregivers during moderate or severe hypoglycemic episodes in adults with type 1 diabetes. ↗
Registered primary question: The proportion of participants awakening or returning to their normal status within 30 minutes, assessed by their caregivers. ↗
What the reviewed report found
Journal year 2018 · Article summary reviewed 2026-09-15
Caregivers reported resolution within 30 minutes in 95.7% of patients. All 12 severe episodes resolved within 15 minutes.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Repeated events are not additional people
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. Full text ↗ · Indexed abstract ↗
Sections: MATERIALS AND METHODS; RESULTS.
Keep the outcome denominator visible
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. Full text ↗ · Indexed abstract ↗
Sections: MATERIALS AND METHODS; Efficacy results.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
129 · reported actual
Registry status
Completed
Allocation and masking
Na · Open label
Design
Single group
Eligible ages
18 Years to 75 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2019-10-15; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Nasal glucagon during spontaneous episodes
Design in the report
Prospective open-label real-world study with trained caregivers and no randomized comparator.↗
Participants in the report
69 adults experienced 157 evaluable moderate or severe hypoglycemia episodes.↗
Limitations
Repeated episodes within people are not independent participants. Caregiver assessment, training and lack of a comparator limit causal and comparative conclusions.↗
Trial identity checked in the full text on 2026-09-20: The methods identify this registered study explicitly; the identifier is not taken from a background citation or ethics approval. Identity source ↗
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in the inspected full-text section. No matching reference is declared in this registry snapshot. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. PubmedArticle[MedlineCitation/PMID=29504662] in the retained EFetch batch. SHA-256 1daf97e8d64d2f5e340838019b187447a2f71a074328ec52b3b722653e07bd1b.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 cdfec7c7ffcb3fe58014d74d781cc1ec070e5afa82732ebc049204945b455e92.
Retrieved 2026-09-20; SHA-256 9bc4b6f5f310ef2f8f286885a580facd851d4902b5af129812693ce23553894f. Section identifiers and hashes are included in the cited study data.
Diabetes · Not applicable
Pramlintide: automated delivery and meal announcements
Automated insulin plus pramlintide with simpler meal announcements compared with automated insulin plus placebo and carbohydrate counting in a crossover study. ↗
Registered primary question: 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. ↗
What the reviewed report found
Journal year 2024 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
36 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Triple
Design
Crossover
Eligible ages
12 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2022-10-10; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Experimental automated delivery
Design in the report
Randomized crossover comparison of three automated-delivery approaches, each studied for 14 days.↗
Participants in the report
32 participants enrolled; 30 completing all interventions were analyzed, including 15 adults and 15 adolescents.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Cagrilintide plus semaglutide versus placebo in adults whose type 2 diabetes was inadequately controlled with diet and exercise. ↗
Registered primary question: Change in HbA1c at week 40. ↗
What the reviewed report found
Journal year 2026 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
189 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-04-02; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
REIMAGINE 1: early type 2 diabetes
Design in the report
A blinded randomized placebo-controlled phase 3a trial assessed 40-week HbA1c change under NCT06323174.↗
Participants in the report
The trial randomized 189 adults whose type 2 diabetes was inadequately controlled with diet and exercise.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Cagrilintide plus semaglutide versus placebo added to basal insulin, with or without metformin. ↗
Registered primary question: Change in HbA1c at week 40. ↗
What the reviewed report found
Journal year 2026 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
274 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-09-09; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
A blinded randomized placebo-controlled phase 3a trial assessed 40-week HbA1c change under NCT06323161.↗
Participants in the report
The study randomized 274 adults with type 2 diabetes receiving basal insulin, with or without metformin.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Retatrutide compared with placebo and dulaglutide in adults with type 2 diabetes. ↗
Registered primary question: Change in HbA1c at week 24. ↗
What the reviewed report found
Journal year 2023 · Article summary reviewed 2026-09-15
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.↗
Keep in context: The report distinguishes 281 randomized participants from 275 included in efficacy analyses. Weight change at week 36 was a secondary endpoint. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
281 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
18 Years to 75 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2023-07-03; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Phase 2 type 2 diabetes trial
Design in the report
A randomized, double-blind, placebo- and active-comparator-controlled Phase 2 trial evaluated glycated hemoglobin at 24 weeks and body weight at 36 weeks.↗
Participants in the report
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.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Retatrutide versus placebo in adults with type 2 diabetes managed with diet and exercise. ↗
Registered primary question: Change in HbA1c from baseline to week 40. ↗
What the reviewed report found
Journal year 2026 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
537 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-03-05; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
TRANSCEND-T2D-1: phase 3 diabetes study
Design in the report
A blinded randomized placebo-controlled trial assessed 40-week glycated hemoglobin change under NCT06354660.↗
Participants in the report
The trial randomized 537 adults with type 2 diabetes inadequately controlled with diet and exercise alone.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
All three active groups improved glycated hemoglobin compared with placebo. Gastrointestinal events were common; seven participants in active groups had serious adverse events.↗
Active groups improved glycated hemoglobin compared with placebo. Gastrointestinal adverse events were common; serious adverse events were reported in active and placebo groups.↗
Keep in context: 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. ↗↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
448 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years to 75 Years
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-08-13; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Oral zenagamtide: phase 2 diabetes cohort
Design in the report
A blinded randomized placebo-controlled study assessed 36-week glycated hemoglobin change under NCT06542874.↗
Participants in the report
This report included 186 adults with type 2 diabetes receiving metformin with or without an SGLT2 inhibitor.↗
Limitations
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.↗
A blinded randomized placebo-controlled study assessed 36-week glycated hemoglobin change under NCT06542874.↗
Participants in the report
This route cohort randomized 262 adults with type 2 diabetes; 261 received treatment.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Open-label lanreotide treatment without a comparison group in acromegaly with pituitary macroadenoma. ↗
Registered primary question: The proportion with a relevant reduction in pituitary tumor volume on MRI at week 48. ↗
What the reviewed report found
Journal year 2014 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Why the favorable percentage was not a positive primary test
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. Full text ↗ · Indexed abstract ↗
Sections: Statistical analyses; Primary endpoint: proportions of patients with ≥ 20% reduction in tumor volume at week 48/LVA.
Completion and adverse-event withdrawals
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. Full text ↗ · Indexed abstract ↗
Sections: Patient disposition and baseline characteristics.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
108 · reported actual
Registry status
Completed
Allocation and masking
Na · Open label
Design
Single group
Eligible ages
18 Years to 75 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2022-10-14; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
PRIMARYS: acromegaly
Design in the report
48-week open-label, single-arm study with centrally assessed tumor volume.↗
Participants in the report
90 treatment-naïve people with acromegaly and growth-hormone-secreting macroadenomas entered; 64 completed.↗
Limitations
No control group, attrition and differences between primary and sensitivity analyses limit causal interpretation. No gastrointestinal-intolerance withdrawals does not mean no adverse events.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 8aedba94eb8490af07f6c229618fa55608624f08d137e1600fb71c413f5ce257. Section identifiers and hashes are included in the cited study data.
Tesamorelin versus placebo in people with HIV-associated abdominal fat accumulation. ↗
Registered primary question: Visceral adipose tissue; the retrieved primary-outcome field does not specify a time frame. ↗
What the reviewed report found
Journal year 2007 · Article summary reviewed 2026-08-19
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
412 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
18 Years to 65 Years
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2013-11-27; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Twenty-six-week visceral-fat trial
Design in the report
A randomized, placebo-controlled trial assessed computed-tomography visceral adipose tissue and metabolic measures over 26 weeks.↗
Participants in the report
The trial randomized 412 adults living with HIV who had abdominal fat accumulation during antiretroviral therapy; 86% were men.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
TH9507 in Patients With HIV-Associated Lipodystrophy ↗ Protocol identifier: TH9507/III/LIPO/010. Sponsor: Theratechnologies. Retrieved 2026-09-20; SHA-256 cb0e4d9209873e96e5201e42be36d3a75d79295f21afeb36ec26b307790764d2.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Intravenous ipamorelin versus placebo after bowel-resection surgery. ↗
Registered primary question: Recovery of gastrointestinal function, assessed daily until hospital discharge. ↗
What the reviewed report found
Journal year 2014 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
117 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years to 85 Years
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2017-04-14; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Postoperative ileus: a placebo-controlled phase 2 trial
Design in the report
A multicenter blinded randomized placebo-controlled study assessed recovery after bowel resection.↗
Participants in the report
The trial enrolled 117 adults; 114 were included in its safety and modified intent-to-treat populations.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Linaclotide versus placebo in adults with chronic constipation. ↗
Registered primary question: 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. ↗
What the reviewed report found
Journal year 2011 · Article summary reviewed 2026-09-20
The primary bowel-response endpoint was reached by 16.0% and 21.3% in the two active groups, compared with 6.0% with placebo.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
633 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2013-01-30; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Adult chronic constipation: Trial 01
Design in the report
A randomized, double-blind, placebo-controlled 12-week trial tested two active groups.↗
Participants in the report
Adults with chronic constipation participated; the abstract reports 1,276 participants across Trials 303 and 01 together, without a separate Trial 01 count.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Linaclotide versus placebo in adults with chronic constipation. ↗
Registered primary question: 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. ↗
What the reviewed report found
Journal year 2011 · Article summary reviewed 2026-09-20
The primary bowel-response endpoint was reached by 21.2% and 19.4% in the two active groups, compared with 3.3% with placebo.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
643 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2013-01-30; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Adult chronic constipation: Trial 303
Design in the report
A randomized, double-blind, placebo-controlled 12-week trial tested two active groups.↗
Participants in the report
Adults with chronic constipation participated; the abstract reports 1,276 participants across Trials 303 and 01 together, without a separate Trial 303 count.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Linaclotide versus placebo in the functional-constipation cohort of a pediatric trial. ↗
Registered primary question: 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. ↗
What the reviewed report found
Journal year 2024 · Article summary reviewed 2026-09-15
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.↗
Keep in context: The registry covers 438 participants across two conditions. This report concerns 330 randomized children with functional constipation, of whom 328 received treatment. ↗↗
Related analyses from this study (1)
These publications examine participants from the study above. They do not add independent trials.
Post hoc analysis · Journal year 2026 · Full-text reading reviewed 2026-09-20
How it relates: A descriptive post hoc subgroup analysis of the pediatric functional-constipation trial. ↗
Question: How did weekly spontaneous bowel movements and tolerability compare over 12 weeks in children with recorded neurodevelopmental conditions? ↗
Participants: 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. ↗
Reported findings: 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. ↗
Limits of this analysis: 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. ↗
Registry source ↗ · Updated 2024-11-26; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
330 children aged 6–17 years were randomized; 328 received treatment and 293 completed.↗
Limitations
The trial addresses functional constipation in the enrolled age range. Its findings cannot establish safety in younger children or replace age-specific label warnings.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Plecanatide versus placebo in adults with chronic idiopathic constipation. ↗
Registered primary question: A sustained complete spontaneous bowel-movement response over 12 treatment weeks. ↗
What the reviewed report found
Journal year 2017 · Article summary reviewed 2026-09-15
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%.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
1,394 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years to 80 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2019-12-26; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Chronic idiopathic constipation: first phase 3 trial
Design in the report
Randomized, double-blind, placebo-controlled trial over 12 weeks with two active groups.↗
Participants in the report
1,394 adults with chronic idiopathic constipation were randomized.↗
Limitations
The endpoint combines frequency and persistence of response. Results concern the enrolled adults and short follow-up, not all constipation causes.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
12-Week Study of Plecanatide for CIC (The CIC3 Study) ↗ Protocol identifier: SP304203-00. Sponsor: Bausch Health Americas, Inc.. Retrieved 2026-09-20; SHA-256 3f56b9edd18ab49f3dcb92da8d278d0667350c6d8deb81bb0c3f3323fa6f8dcf.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Plecanatide versus placebo in adults with chronic idiopathic constipation. ↗
Registered primary question: A sustained complete spontaneous bowel-movement response over 12 treatment weeks. ↗
What the reviewed report found
Journal year 2017 · Article summary reviewed 2026-09-20
Durable responder rates were 20.1% and 20.0% versus 12.8%. Diarrhea occurred in 3.2% and 4.5% versus 1.3%.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Participant counts describe different groups
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. Full text ↗ · Indexed abstract ↗
Sections: Statistical analysis; Results.
A sustained response, not a single improved week
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. Full text ↗ · Indexed abstract ↗
Sections: Efficacy; Statistical analysis.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
1,410 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years to 80 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2019-05-28; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Chronic idiopathic constipation: second phase 3 trial
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 d6571ec3c539f7bdcacbd6f5e981e25851c7083e204cfccca3818e1fc5be3701. Section identifiers and hashes are included in the cited study data.
Pemvidutide versus placebo in adults with biopsy-confirmed steatohepatitis and stage F2 or F3 fibrosis. ↗
Registered primary question: 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. ↗
What the reviewed report found
Journal year 2025 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
212 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years to 75 Years
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-05-18; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
IMPACT: biopsy-confirmed MASH
Design in the report
Randomized, double-blind, placebo-controlled phase 2 trial; NCT05989711; two coprimary histology endpoints at week 24.↗
Participants in the report
212 participants with MASH and stage F2 or F3 fibrosis participated.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Continued pemvidutide or placebo in eligible completers of a preceding 12-week MASLD trial. ↗
Registered primary question: The number of participants with treatment-emergent adverse events through day 110. ↗
What the reviewed report found
Journal year 2025 · Article summary reviewed 2026-09-15
At 24 weeks, reported relative liver-fat reductions were 56.3%, 75.2% and 76.4% in active groups versus 14.0% with placebo.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
How the extension population was selected
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. Full text ↗ · Indexed abstract ↗
Sections: Trial design and participant selection; Trial participants; Discussion.
What the measurements can establish
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. Full text ↗ · Indexed abstract ↗
Sections: Efficacy endpoints; Discussion.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
64 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
18 Years to 65 Years
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2023-07-27; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
MASLD extension
Design in the report
Double-blind extension of a preceding randomized trial; NCT05292911.↗
Participants in the report
64 participants from the earlier 94-participant study continued; this is not a new independently randomized cohort.↗
Limitations
Selective extension participation can bias interpretation. MRI liver fat is not the same as histologic fibrosis improvement or patient-important liver outcomes.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 09c6267d051dca6790e48cda688cf681e282ea25bbfd909cede12bb4f78f672c. Section identifiers and hashes are included in the cited study data.
Survodutide versus placebo in adults with biopsy-confirmed steatohepatitis and fibrosis. ↗
Registered primary question: Improvement in liver histology after 48 weeks, with analyses by planned and actual maintenance treatment. ↗
What the reviewed report found
Journal year 2024 · Article summary reviewed 2026-09-15
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.↗
Keep in context: The reported primary result was improvement in steatohepatitis without worsening fibrosis. Improvement in fibrosis itself was a separate secondary outcome. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
295 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years to 80 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2024-12-03; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Phase 2 MASH and fibrosis trial
Design in the report
A randomized, placebo-controlled Phase 2 trial assessed histologic improvement in steatohepatitis without worsening fibrosis over 48 weeks.↗
Participants in the report
The trial treated 293 adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis and fibrosis stages F1 through F3.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Tesamorelin versus placebo in antiretroviral-treated patients with HIV and abdominal fat accumulation. ↗
Registered primary question: Change in visceral adipose tissue and liver fat at six months. ↗
What the reviewed report found
Journal year 2014 · Article summary reviewed 2026-08-19
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
54 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years to 65 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2017-10-30; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Six-month visceral- and liver-fat trial
Design in the report
A double-blind, randomized, placebo-controlled preliminary trial assessed visceral adipose tissue, liver fat, and metabolic measures over six months.↗
Participants in the report
The single-center trial enrolled 50 antiretroviral-treated adults living with HIV and abdominal fat accumulation; 48 received study treatment.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
Effects of Growth Hormone Releasing Hormone in HIV ↗ Protocol identifier: 2007p-000638. Sponsor: Massachusetts General Hospital. Retrieved 2026-09-20; SHA-256 b996f043d627ecf369e566b4310ec94ae9593dd87ac8e98ebdf8c25c73535ee7.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Open-label afamelanotide in six patients with acute ischemic stroke who could not receive the specified revascularization treatments. ↗
Registered primary question: Change in infarct volume from day 0 to days 3 and 9. ↗
What the reviewed report found
Journal year 2023 · Article summary reviewed 2026-09-15
The surviving patients showed neurological improvement. One patient died after a recurrent stroke, which investigators assessed as unrelated to the study drug.↗
Keep in context: The registry lists imaging as the primary outcome; the article emphasizes feasibility and safety. Six uncontrolled observations cannot establish treatment efficacy or safety. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Outcome emphasis differs between sources
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. Full text ↗ · Indexed abstract ↗
Sections: Outcome measures.
What uncontrolled recovery can show
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. Full text ↗ · Indexed abstract ↗
Sections: Study design and patient population; Strengths and limitations.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
6 · reported actual
Registry status
Completed
Allocation and masking
Na · Open label
Design
Single group
Eligible ages
18 Years to 85 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2023-04-11; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Acute stroke: early feasibility study
Design in the report
An open-label Phase 2a study assessed safety and exploratory recovery measures without a control group.↗
Participants in the report
Six patients with acute ischemic stroke who were ineligible for revascularization therapies were enrolled.↗
Limitations
Six uncontrolled observations cannot distinguish drug effects from natural recovery or establish safety. The authors called for randomized studies.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 a007a591d4823f9616594f8dd8d1d57bf73ca8fc1769c47af482c6167dc795ce. Section identifiers and hashes are included in the cited study data.
Lixisenatide versus placebo alongside stable treatment for Parkinson symptoms. ↗
Registered primary question: Change in the MDS-UPDRS part III motor score at month 12. ↗
What the reviewed report found
Journal year 2024 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
156 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
40 Years to 75 Years
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2025-11-28; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
LIXIPARK: exploratory Parkinson trial
Design in the report
Randomized, double-blind, placebo-controlled phase 2 trial with 12 months of treatment and a two-month washout.↗
Participants in the report
156 people with early Parkinson disease were randomized while receiving stable symptomatic therapy.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Lanreotide versus placebo in people with nonfunctioning enteropancreatic neuroendocrine tumors. ↗
Registered primary question: Time to tumor progression or death, with assessments scheduled through week 96. ↗
What the reviewed report found
Journal year 2014 · Article summary reviewed 2026-09-15
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%.↗
Keep in context: The report describes 204 randomized participants; the registry lists 264 enrolled. Improved progression-free survival in this report did not demonstrate improved overall survival. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
264 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2025-03-05; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
CLARINET: neuroendocrine tumors
Design in the report
Randomized, double-blind, placebo-controlled trial over 96 weeks.↗
Participants in the report
204 people with advanced nonfunctioning, somatostatin-receptor-positive grade 1 or 2 neuroendocrine tumors; most had stable disease before enrollment.↗
Limitations
The selected tumor grades, receptor status and largely stable baseline disease limit generalization. Progression-free survival is distinct from longer overall survival.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Relugolix versus leuprolide in men with advanced prostate cancer; leuprolide was the active comparator. ↗
Registered primary question: Sustained testosterone suppression from day 29 through day 337. ↗
What the reviewed report found
Journal year 2020 · Article summary reviewed 2026-09-20
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
1,134 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Open label
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2022-01-18; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
HERO androgen-deprivation trial
Design in the report
A sponsor-funded, randomized Phase 3 trial compared oral relugolix with leuprolide for 48 weeks; sustained testosterone suppression was the primary endpoint.↗
Participants in the report
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.↗
Limitations
Leuprolide was the comparator, not the experimental treatment, and the primary result concerned testosterone suppression rather than cancer progression or survival.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference BACKGROUND. These source labels do not establish that every result in a paper applies to this trial.
Related cohort: This extension follows eligible participants from the original CLARINET cohort. It has a separate registration but an overlapping population. Parent study NCT00353496 → · Relationship source ↗
What was tested?
Open-label lanreotide in eligible participants from the CLARINET core trial, including people previously assigned placebo. ↗
Registered primary question: Adverse events throughout the extension; the registry identifies safety as the primary outcome. ↗
What the reviewed report found
Journal year 2021 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Different questions use different populations
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. Full text ↗ · Indexed abstract ↗
Sections: Populations and subgroups; Patients and treatment exposure; Efficacy.
The survival clock starts in the core trial
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. Full text ↗ · Indexed abstract ↗
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. Full text ↗ · Indexed abstract ↗
Sections: Statistical analyses; Efficacy.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
89 · reported actual
Registry status
Completed
Allocation and masking
Na · Open label
Design
Single group
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2022-10-12; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
CLARINET open-label extension
Design in the report
Eligible original-trial participants entered an extension in which everyone received lanreotide.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. PubmedArticle[MedlineCitation/PMID=33052555] in the retained EFetch batch. SHA-256 0e6795be99af1c93f3a3e2726fc8a17152661ca29e8dead110bff36feb856127.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 965ff6216bbf51d5c511964f6dc349e1756d0980802f50665ca54b21e9fd4f86.
Retrieved 2026-09-20; SHA-256 2e6405d67f8dff7f445d87c023263c18fe6392aab05e091b0d0c430a635cb08c. Section identifiers and hashes are included in the cited study data.
Afamelanotide versus placebo in people with erythropoietic protoporphyria. ↗
Registered primary question: Direct sunlight exposure without phototoxicity-related pain between 10:00 and 15:00, from baseline through day 270. ↗
What the reviewed report found
Journal year 2015 · Article summary reviewed 2026-09-20
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
74 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years to 70 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2021-10-12; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
EPP: European placebo-controlled trial
Design in the report
A randomized, double-blind, placebo-controlled trial followed pain-free sunlight exposure over nine months.↗
Participants in the report
The abstract reports 74 participants with erythropoietic protoporphyria in the European trial.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Afamelanotide versus placebo in people with erythropoietic protoporphyria. ↗
Registered primary question: Direct sunlight exposure without pain between 10:00 and 18:00, recorded daily for six months. ↗
What the reviewed report found
Journal year 2015 · Article summary reviewed 2026-09-20
Median pain-free sunlight exposure was 69.4 hours with afamelanotide versus 40.8 hours with placebo over six months.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
93 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2019-09-19; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
EPP: US placebo-controlled trial
Design in the report
A randomized, double-blind, placebo-controlled trial followed pain-free sunlight exposure over six months.↗
Participants in the report
The abstract reports 94 participants with erythropoietic protoporphyria in the US trial.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Elamipretide versus placebo in people with primary mitochondrial myopathy. ↗
Registered primary question: Change in six-minute walking distance and symptom-assessment total fatigue score at week 24. ↗
What the reviewed report found
Journal year 2023 · Article summary reviewed 2026-09-15
Neither walking distance nor fatigue met the primary efficacy endpoint. Most reported adverse events were mild or moderate.↗
Keep in context: Neither primary endpoint was met. Findings in primary mitochondrial myopathy should not be substituted for evidence in Barth syndrome. ↗↗
Related analyses from this study (1)
These publications examine participants from the study above. They do not add independent trials.
Post hoc analysis · Journal year 2024 · Full-text reading reviewed 2026-09-20
MMPOWER-3: exploratory genotype subgroups
How it relates: Further exploratory analyses of MMPOWER-3 per-protocol completers, following a parent trial that missed its primary endpoints. ↗
Question: Did changes in six-minute walking distance differ within selected genetic and clinical subgroups? ↗
Participants: The highlighted subgroup combined a mitochondrial DNA replisome genotype with chronic progressive external ophthalmoplegia: 18 elamipretide and 14 placebo participants from the original trial. ↗
Reported findings: 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. ↗
Limits of this analysis: 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. ↗
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Overall result versus exploratory subgroup
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. Full text ↗ · Indexed abstract ↗
Sections: Subgroup Analyses by PMM Genotype; Primary Endpoints of Overall ITT; Analyses by Genetic Subgroup: mtDNA vs nDNA; Discussion.
An abstract and full-text discrepancy
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. Full text ↗ · Indexed abstract ↗
Sections: Primary Endpoints of Overall ITT.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
218 · reported actual
Registry status
Terminated
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
16 Years to 80 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2022-01-24; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
MMPOWER-3: primary mitochondrial myopathy
Design in the report
A randomized, blinded, placebo-controlled phase 3 trial assessed 24-week outcomes.↗
Participants in the report
The study randomized 218 participants with genetically confirmed primary mitochondrial myopathy.↗
Limitations
This is a different disease population from Barth syndrome. Overall null results cannot be replaced by favorable exploratory subgroup findings.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 35fbf3139ae775f5ff4d3a011ce2461ea5cf7dc8eef296f1f8abf47cc56f1342. Section identifiers and hashes are included in the cited study data.
Setmelanotide in a genetically defined obesity cohort, including response-selected blinded withdrawal. ↗
Registered primary question: The proportion of the pivotal cohort reaching at least 10% weight loss after approximately one year. ↗
What the reviewed report found
Journal year 2020 · Article summary reviewed 2026-09-20
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
15 · reported actual
Registry status
Completed
Allocation and masking
Na · Open label
Design
Single group
Eligible ages
6 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2023-05-23; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
LEPR-deficiency obesity trial
Design in the report
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.↗
Participants in the report
Eleven participants aged at least six years with LEPR-deficiency obesity were included in the full analysis and safety sets.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Setmelanotide in a genetically defined obesity cohort, including response-selected blinded withdrawal. ↗
Registered primary question: The proportion of the pivotal cohort reaching at least 10% weight loss after approximately one year. ↗
What the reviewed report found
Journal year 2020 · Article summary reviewed 2026-09-20
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
15 · reported actual
Registry status
Completed
Allocation and masking
Na · Open label
Design
Single group
Eligible ages
6 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2023-09-21; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
POMC-deficiency obesity trial
Design in the report
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.↗
Participants in the report
Ten participants aged at least six years with POMC-deficiency obesity were included in the full analysis and safety sets.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Elamipretide versus placebo in a crossover study of people with genetically confirmed Barth syndrome, followed by open-label treatment. ↗
Registered primary question: Six-minute walking distance and total fatigue score during the controlled 12-week treatment periods. ↗
What the reviewed report found
Journal year 2021 · Article summary reviewed 2026-09-15
Neither primary endpoint was met in the randomized period. Walking distance and reported fatigue improved during the uncontrolled extension.↗
Keep in context: The controlled phase did not meet either primary endpoint. Later open-label improvements come from a smaller group without a concurrent placebo comparison. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
One cohort, two different phases
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. Full text ↗ · Indexed abstract ↗
Sections: Patient characteristics; Outcomes and follow-up: part 1—placebo-controlled study; Outcomes and follow-up: part 2—open-label extension.
The extension changes the main question
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. Full text ↗ · Indexed abstract ↗
Sections: Outcome measures; Outcomes and follow-up: part 1—placebo-controlled study; Outcomes and follow-up: part 2—open-label extension; Limitations.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
12 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Crossover
Eligible ages
12 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2024-04-16; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
TAZPOWER: randomized and early extension results
Design in the report
A blinded placebo-controlled crossover trial was followed by an open-label extension.↗
Participants in the report
Twelve participants with Barth syndrome entered the randomized study; ten entered the extension and eight reached 36 weeks.↗
Limitations
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.↗
Trial identity checked in the full text on 2026-09-20: The methods identify this registered study explicitly; the identifier is not taken from a background citation or ethics approval. Identity source ↗
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in the inspected full-text section. No matching reference is declared in this registry snapshot. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. PubmedArticle[MedlineCitation/PMID=33077895] in the retained EFetch batch. SHA-256 0e6795be99af1c93f3a3e2726fc8a17152661ca29e8dead110bff36feb856127.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 7be61a5476f72d7700d76f4e84d64de9269524a305e0f8591b3575519602e747.
Retrieved 2026-09-20; SHA-256 ea8b01a5464860686aba02cae7e90c580dc554558f0b00b68f4745f33b106277. Section identifiers and hashes are included in the cited study data.
Bremelanotide versus placebo in premenopausal women with selected sexual-function disorders. ↗
Registered primary question: Change in the number of satisfying sexual events per month during 12 weeks of randomized treatment. ↗
What the reviewed report found
Journal year 2016 · Article summary reviewed 2026-09-15
The pooled active groups improved reported satisfying sexual events and questionnaire measures compared with placebo; nausea, flushing and headache were reported.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Why the participant counts differ
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. Full text ↗ · Indexed abstract ↗
Sections: Participant flow.
Primary result versus exploratory secondary findings
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. Full text ↗ · Indexed abstract ↗
Sections: Statistical analyses; Efficacy.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
612 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Triple
Design
Parallel
Eligible ages
21 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2014-12-18; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Phase 2 dose-finding study
Design in the report
A randomized placebo-controlled study assessed outcomes over 12 weeks.↗
Participants in the report
The efficacy analysis included 327 premenopausal women with female sexual dysfunction.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 5f3ed19a1ea4f1fb136b35b91fc9f2dbeaa9d4d30f748dc67de198db63cea00f. Section identifiers and hashes are included in the cited study data.
Bremelanotide versus placebo in premenopausal women with acquired, generalized hypoactive sexual desire disorder. ↗
Registered primary question: 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. ↗
What the reviewed report found
Journal year 2019 · Article summary reviewed 2026-09-20
Compared with placebo, the reported treatment differences were +0.30 points on the desire measure and −0.37 points on the related-distress measure.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Use this trial’s analysis population
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. Full text ↗ · Indexed abstract ↗
Sections: METHODS; RESULTS.
A favorable post hoc measure does not replace the failed endpoint
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. Full text ↗ · Indexed abstract ↗
Sections: METHODS; RESULTS.
Withdrawal and missing observations matter
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. Full text ↗ · Indexed abstract ↗
Sections: METHODS; RESULTS; DISCUSSION.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
723 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Triple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2021-04-09; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
RECONNECT: study 301
Design in the report
A randomized, double-blind, placebo-controlled trial assessed changes in desire and related distress during a 24-week treatment period.↗
Participants in the report
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.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. PubmedArticle[MedlineCitation/PMID=31599840] in the retained EFetch batch. SHA-256 b9b2737876819a52052ecd9dc7208be1ad5712f7a133c5c13d04f6663f02d118.
Scientific summary uses the original 2026-09-20 source snapshot: SHA-256 b9b2737876819a52052ecd9dc7208be1ad5712f7a133c5c13d04f6663f02d118.
Retrieved 2026-09-20; SHA-256 d939a9d3502b7945efc876a08c392a8d6c4de8cd6a36f2e1dc0c06daa03199bb. Section identifiers and hashes are included in the cited study data.
Bremelanotide versus placebo in premenopausal women with acquired, generalized hypoactive sexual desire disorder. ↗
Registered primary question: 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. ↗
What the reviewed report found
Journal year 2019 · Article summary reviewed 2026-09-20
Compared with placebo, the reported treatment differences were +0.42 points on the desire measure and −0.29 points on the related-distress measure.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Use this trial’s analysis population
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. Full text ↗ · Indexed abstract ↗
Sections: METHODS; RESULTS.
A favorable post hoc measure does not replace the failed endpoint
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. Full text ↗ · Indexed abstract ↗
Sections: METHODS; RESULTS.
Withdrawal and missing observations matter
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. Full text ↗ · Indexed abstract ↗
Sections: METHODS; RESULTS; DISCUSSION.
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
714 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Triple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2021-01-28; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
RECONNECT: study 302
Design in the report
A randomized, double-blind, placebo-controlled trial assessed changes in desire and related distress during a 24-week treatment period.↗
Participants in the report
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.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. PubmedArticle[MedlineCitation/PMID=31599840] in the retained EFetch batch. SHA-256 b9b2737876819a52052ecd9dc7208be1ad5712f7a133c5c13d04f6663f02d118.
Scientific summary uses the original 2026-09-20 source snapshot: SHA-256 b9b2737876819a52052ecd9dc7208be1ad5712f7a133c5c13d04f6663f02d118.
Retrieved 2026-09-20; SHA-256 d939a9d3502b7945efc876a08c392a8d6c4de8cd6a36f2e1dc0c06daa03199bb. Section identifiers and hashes are included in the cited study data.
Afamelanotide plus narrowband UV-B phototherapy compared with phototherapy alone in adults with nonsegmental vitiligo. ↗
Registered primary question: Changes in pigmentation assessed with VASI and VETF measures across specified body regions over six months. ↗
What the reviewed report found
Journal year 2015 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
56 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Open label
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2013-03-22; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Vitiligo: afamelanotide plus phototherapy
Design in the report
A randomized multicenter study compared afamelanotide plus narrowband UV-B with phototherapy alone.↗
Participants in the report
The study enrolled 55 adults with nonsegmental vitiligo and Fitzpatrick skin phototypes III–VI.↗
Limitations
The study does not isolate afamelanotide without phototherapy or establish results in all skin phototypes. PubMed links subsequent correspondence about the study.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Maridebart cafraglutide, also called AMG 133, versus placebo in an ascending-dose study in people with obesity. ↗
Registered primary question: The number of participants with treatment-emergent adverse events, with observation windows varying by study part. ↗
What the reviewed report found
Journal year 2024 · Article summary reviewed 2026-09-15
The authors reported weight reductions in the early human program alongside pharmacologic and preclinical findings.↗
Keep in context: 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. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Which participants are in this report
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. Full text ↗ · Indexed abstract ↗
Sections: Clinical study design.
Exploratory weight findings
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. Full text ↗ · Indexed abstract ↗
Registry source ↗ · Updated 2025-12-10; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Early translational and human program
Design in the report
The publication combines preclinical experiments with an early randomized clinical trial.↗
Participants in the report
The human trial enrolled people with obesity; animal findings in the same report are not human outcomes.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in the article abstract indexed in PubMed. The registry independently labels this reference BACKGROUND. These source labels do not establish that every result in a paper applies to this trial.
Retrieved 2026-09-20; SHA-256 478426a0d5db2904b80277b75c031bfc0e86e4d615de08b17435270cb227511c. Section identifiers and hashes are included in the cited study data.
Cagrilintide compared with placebo and liraglutide in adults with overweight or obesity, excluding diabetes. ↗
Registered primary question: Percentage change in body weight at week 26. ↗
What the reviewed report found
Journal year 2021 · Article summary reviewed 2026-09-20
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
706 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2024-07-05; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Phase 2 weight-management trial
Design in the report
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.↗
Participants in the report
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.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Mazdutide versus placebo in Chinese adults with overweight or obesity. ↗
Registered primary question: Percentage weight change and the proportion losing at least 5% of baseline weight at week 32. ↗
What the reviewed report found
Journal year 2025 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
610 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Triple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2024-11-12; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
610 adults with overweight or obesity participated.↗
Limitations
The study concerns its enrolled population and prespecified follow-up. Weight change alone cannot establish cardiovascular benefit or longer-term safety.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Maridebart cafraglutide versus placebo in separate cohorts with obesity, with or without type 2 diabetes. ↗
Registered primary question: Percentage change in body weight at week 52. ↗
What the reviewed report found
Journal year 2025 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
592 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years to 99 Years
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-01-20; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Phase 2 obesity trial
Design in the report
Randomized, placebo-controlled 52-week trial with multiple active groups; NCT05669599.↗
Participants in the report
592 participants: 465 with obesity without diabetes and 127 with obesity and type 2 diabetes.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference BACKGROUND. These source labels do not establish that every result in a paper applies to this trial.
Mazdutide versus placebo in US adults with overweight or obesity, excluding diabetes. ↗
Registered primary question: Percentage change in body weight at week 32. ↗
What the reviewed report found
Journal year 2026 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
179 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
18 Years to 75 Years
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2026-04-21; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
US phase 2 obesity trial
Design in the report
Randomized, placebo-controlled phase 2 trial with a week-32 primary endpoint and longer follow-up.↗
Participants in the report
179 adults with overweight or obesity participated.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Oral amycretin versus placebo in several early ascending-exposure cohorts. ↗
Registered primary question: The number of treatment-emergent adverse events, with follow-up windows of 22, 31 or 105 days depending on study part. ↗
What the reviewed report found
Journal year 2025 · Article summary reviewed 2026-09-15
Treatment-emergent adverse events were reported in 89 participants and were mild or moderate; gastrointestinal events were common.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
144 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Sequential
Eligible ages
18 Years to 55 Years
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2025-06-15; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Oral amycretin: first-in-human study
Design in the report
A blinded randomized placebo-controlled phase 1 study contained several escalating-exposure parts.↗
Participants in the report
The study enrolled 144 adults with overweight or obesity across its parts.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Cagrilintide plus semaglutide, either component alone, or placebo alongside lifestyle intervention. ↗
Registered primary question: Percentage weight change and the proportion losing at least 5% of baseline weight at week 68, comparing the combination with placebo. ↗
What the reviewed report found
Journal year 2025 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
3,400 · estimated
Registry status
Active not recruiting
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
Minimum not specified; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-08-31; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
REDEFINE 1: combination treatment without diabetes
Design in the report
A blinded randomized phase 3a trial compared combination treatment, either component alone and placebo over 68 weeks under NCT05567796.↗
Participants in the report
The trial randomized 3,417 adults with overweight or obesity without diabetes across four groups.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Cagrilintide plus semaglutide versus placebo, with lifestyle intervention, in adults with type 2 diabetes and excess body weight. ↗
Registered primary question: Percentage weight change and the proportion losing at least 5% of baseline weight at week 68. ↗
What the reviewed report found
Journal year 2025 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
1,200 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-01-28; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
REDEFINE 2: combination treatment with diabetes
Design in the report
A blinded randomized placebo-controlled phase 3a trial assessed weight endpoints at 68 weeks under NCT05394519.↗
Participants in the report
The study randomized 1,206 adults with type 2 diabetes and overweight or obesity.↗
Limitations
This comparison evaluates the combination against placebo, not either component alone. Weight and glycemic outcomes do not establish prevention of long-term complications.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Retatrutide versus placebo in adults with overweight or obesity. ↗
Registered primary question: Percentage change in body weight at week 24. ↗
What the reviewed report found
Journal year 2023 · Article summary reviewed 2026-09-15
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.↗
Keep in context: The often-cited 48-week weight results are secondary outcomes; the primary endpoint was measured at week 24. ↗↗
Related analyses from this study (1)
These publications examine participants from the study above. They do not add independent trials.
Substudy · Journal year 2024 · Full-text reading reviewed 2026-09-20
Retatrutide: liver-fat imaging substudy
How it relates: A liver-imaging substudy within the phase 2 obesity trial, restricted to participants meeting an additional liver-fat criterion. ↗
Question: How did relative liver fat measured by MRI change at week 24? Week-48 change was secondary, and several normalization thresholds were exploratory. ↗
Participants: 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. ↗
Reported findings: 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. ↗
Limits of this analysis: 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. ↗
Registry source ↗ · Updated 2023-09-13; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Phase 2 obesity trial
Design in the report
A double-blind, randomized, placebo-controlled Phase 2 trial followed participants for 48 weeks and assessed body-weight change and safety.↗
Participants in the report
The trial enrolled 338 adults with obesity, or overweight plus at least one weight-related condition.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Liraglutide versus placebo alongside lifestyle intervention in adults with overweight or obesity, excluding diabetes. ↗
Registered primary question: 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. ↗
What the reviewed report found
Journal year 2015 · Article summary reviewed 2026-08-19
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
3,731 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Posted in this snapshot
Registry source ↗ · Updated 2018-01-19; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
SCALE weight-management trial
Design in the report
A double-blind, randomized, placebo-controlled trial assessed body-weight change over 56 weeks alongside lifestyle counseling.↗
Participants in the report
The trial randomized 3,731 adults without type 2 diabetes who had obesity, or overweight with dyslipidemia or hypertension.↗
Limitations
The sponsor-funded trial combined treatment with lifestyle counseling, excluded type 2 diabetes, and used imputation for the reported mean weight-change analysis.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Subcutaneous semaglutide versus placebo, alongside lifestyle intervention. ↗
Registered primary question: Percentage weight change and the proportion losing at least 5% of baseline weight at week 68. ↗
What the reviewed report found
Journal year 2021 · Article summary reviewed 2026-08-18
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.↗
Keep in context: 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. ↗↗
Related analyses from this study (1)
These publications examine participants from the study above. They do not add independent trials.
How it relates: An exploratory extension of STEP 1 followed selected participants after both study medication and structured lifestyle support stopped at week 68. ↗
Question: How did body weight change during the following 52 weeks without the trial's assigned treatment? ↗
Participants: Of 333 extension entrants, 327 entered the analysis set; 290 had on-site measurements at week 120. These were participants from the original trial, not a newly randomized cohort. ↗
Reported findings: 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. ↗
Limits of this analysis: 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. ↗
Registry source ↗ · Updated 2021-11-19; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
STEP 1 weight-management trial
Design in the report
A double-blind, randomized, placebo-controlled trial followed participants for 68 weeks alongside a lifestyle intervention.↗
Participants in the report
The trial enrolled 1,961 adults with obesity, or overweight plus at least one weight-related condition, who did not have diabetes.↗
Limitations
The sponsor-funded trial combined treatment with lifestyle intervention, excluded people with diabetes, and does not by itself establish outcomes after treatment stops.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference RESULT. These source labels do not establish that every result in a paper applies to this trial.
Subcutaneous amycretin versus placebo across several cohorts with different treatment durations. ↗
Registered primary question: The number of treatment-emergent adverse events, assessed through the end of each study part. ↗
What the reviewed report found
Journal year 2025 · Article summary reviewed 2026-09-15
Estimated weight reductions were greater with amycretin. Gastrointestinal events were common, and the authors reported many study withdrawals.↗
Keep in context: Weight findings came from small cohorts followed for different lengths of time. The authors reported substantial withdrawal, which limits interpretation of the estimates. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
125 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years to 55 Years
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2025-11-19; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Subcutaneous amycretin: phase 1b/2a study
Design in the report
A randomized placebo-controlled multipart study assessed safety and secondary body-weight changes over up to 36 weeks.↗
Participants in the report
The study randomized 125 adults with overweight or obesity at one research center.↗
Limitations
Primary endpoints concerned adverse events. Small cohorts, different observation lengths and substantial attrition limit comparisons and interpretation of weight estimates.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Tirzepatide versus placebo in adults with overweight or obesity, excluding diabetes. ↗
Registered primary question: Percentage weight change and the proportion losing at least 5% of baseline weight at week 72. ↗
What the reviewed report found
Journal year 2022 · Article summary reviewed 2026-08-19
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.↗
Keep in context: 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. ↗↗
Related analyses from this study (4)
These publications examine participants from the study above. They do not add independent trials.
How it relates: A report of patient-reported outcomes from SURMOUNT-1, with treatment-group comparisons and separate post hoc analyses of associations with weight reduction. ↗
Question: How did reported health-related quality of life, including physical and psychosocial functioning, change over 72 weeks? ↗
Participants: 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. ↗
Reported findings: 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. ↗
Limits of this analysis: 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. ↗
Post hoc analysis · Journal year 2026 · Full-text reading reviewed 2026-09-20
SURMOUNT-1: baseline physical-function subgroups
How it relates: 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. ↗
Question: Within SURMOUNT-1, how did changes in self-reported physical function at week 72 vary by baseline physical-function quartile? ↗
Participants: 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. ↗
Reported findings: 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. ↗
Limits of this analysis: 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. ↗
Post hoc analysis · Journal year 2025 · Full-text reading reviewed 2026-09-20
SURMOUNT-1: a retrospective definition of weight plateau
Source correction: 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. Correction in the article ↗
How it relates: This reading covers SURMOUNT-1 participants only; the paper also analyzes SURMOUNT-4. These are reused trial participants, not a new trial. ↗
Question: When did weight change remain below 5% in every subsequent 12-week interval? This definition does not mean weight stopped changing. ↗
Participants: 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. ↗
Reported findings: By week 72, approximately 88–90% met this plateau definition across baseline BMI groups. The corrected abstract identifies week 72 as the time point. ↗
Limits of this analysis: 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. ↗
Post hoc analysis · Journal year 2025 · Full-text reading reviewed 2026-09-20
SURMOUNT-1: early and later weight-response patterns
How it relates: This descriptive post hoc analysis reuses the tirzepatide-treated SURMOUNT-1 cohort, without a placebo comparison for these response categories. ↗
Question: Among selected adherent participants, how did week-72 weight outcomes differ according to weight change at week 12? ↗
Participants: 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. ↗
Reported findings: 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. ↗
Limits of this analysis: 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. ↗
Registry source ↗ · Updated 2025-07-24; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
SURMOUNT-1 obesity trial
Design in the report
A double-blind, randomized, placebo-controlled Phase 3 trial assessed body-weight change over 72 weeks.↗
Participants in the report
The trial randomized 2,539 adults with obesity, or overweight plus at least one weight-related complication, and excluded people with diabetes.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Survodutide versus placebo alongside lifestyle intervention in adults with overweight or obesity, excluding diabetes. ↗
Registered primary question: Percentage weight change and the proportion losing at least 5% of baseline weight at week 76. ↗
What the reviewed report found
Journal year 2026 · Article summary reviewed 2026-09-15
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.↗
Keep in context: 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. ↗↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
726 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Quadruple
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-03-12; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
SYNCHRONIZE-1: phase 3 obesity study
Design in the report
A blinded randomized placebo-controlled trial assessed percentage weight change and at least 5% weight reduction at 76 weeks, under NCT06066515.↗
Participants in the report
The report describes 725 adults with obesity or overweight with a related complication, excluding diabetes.↗
Limitations
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.↗
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Petrelintide versus placebo in adults with overweight or obesity and type 2 diabetes. ↗
Registered primary question: Percentage change in body weight at week 28. ↗
What is available so far
This card describes a registered study. No publication results have been appraised for this card. The retrieved registry record does not contain posted results. ↗
Keep in context: This registered population has type 2 diabetes. The retrieved record contains no posted results; this card does not substitute for a published results appraisal. ↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
221 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-09-09; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Petrelintide versus placebo in adults with obesity or overweight with weight-related conditions. ↗
Registered primary question: Percentage change in body weight at week 28. ↗
What is available so far
This card describes a registered study. No publication results have been appraised for this card. The retrieved registry record does not contain posted results. ↗
Keep in context: 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. ↗
Participants, design, limitations and sources
Registry snapshot
Registry enrollment
493 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Double
Design
Parallel
Eligible ages
18 Years; maximum not specified
Registry results
Not posted in this snapshot
Registry source ↗ · Updated 2026-03-23; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Begin with a reviewed profile or a registry record
Use the cards below when you want the registered question and its exact source links. For broader, bounded context, start with a profile review; for records outside this selected collection, browse the wider registry explorer.
The registry fields are sponsor-submitted records, not regulatory endorsement. Article summaries identify their review scope and original review date. A fresh registry check does not mean a fresh full-text appraisal.
Different populations, comparators and endpoints prevent simple rankings across studies. Enrollment may differ from the analyzed population; extension reports may follow the same people. The source links and preserved versions let you inspect those boundaries.