{ "schemaVersion": "peptidescanner-official-source-notes/v1", "boundary": "Dated, scoped source readings. FDA communications are agency statements; ClinicalTrials.gov records are sponsor-submitted registry information, not regulatory endorsement. PDF locations are one-based file pages. No medical advice or vendor endorsement.", "notes": [ { "peptideSlug": "semaglutide", "version": 1, "publishedAt": "2026-09-16", "reviewedAt": "2026-09-16", "scope": "Selected FDA safety communications, read alongside the separately preserved product-label account and human evidence review.", "findings": [ { "heading": "FDA revisited the psychiatric-safety warning", "text": "On January 13, 2026, FDA requested removal of the suicidal-behavior and ideation warning from Wegovy labeling after its review found no increased risk. This records the agency’s request, not a claim that every label version has changed.", "citations": [ { "sourceId": "glp-safety", "locationId": "action" } ] }, { "heading": "What supported that finding", "text": "FDA combined 91 placebo-controlled trials involving 107,910 participants and examined a separate Sentinel claims cohort. These are class-wide analyses, not a dedicated trial of this peptide or a finding about every possible adverse effect.", "citations": [ { "sourceId": "glp-safety", "locationId": "evidence" } ] }, { "heading": "The chemical form matters", "text": "FDA distinguishes semaglutide sodium and acetate from the active ingredient in approved drugs; it lacks information establishing the same chemical and pharmacologic properties. Evidence about an approved product should not be transferred automatically to those salts.", "citations": [ { "sourceId": "glp-unapproved", "locationId": "salts" } ] } ], "remainingWork": [ "Reconcile each current product and formulation label with subsequent safety and indication changes.", "Appraise remaining eligible trial reports and follow-up studies; this update does not complete the literature review." ], "sources": [ { "id": "glp-safety", "title": "FDA January 2026 GLP-1 psychiatric-safety communication", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "semaglutide", "tirzepatide" ], "url": "https://www.fda.gov/media/190557/download?attachment=", "retrievalUrl": "https://www.fda.gov/media/190557/download?attachment=", "sourceDate": "2026-01-13", "retrievedAt": "2026-09-16", "payloadSha256": "d2cc0d43605a9300646146c86f0fd4b84611ada2272de7e65425f33fb7aae53c", "pageCount": 3, "locations": [ { "id": "action", "label": "What Is FDA Doing?", "pages": [ 1 ] }, { "id": "evidence", "label": "What Did FDA Find?", "pages": [ 2, 3 ] } ] }, { "id": "glp-unapproved", "title": "FDA concerns with unapproved GLP-1 drugs", "authority": "FDA", "kind": "web", "peptideSlugs": [ "semaglutide", "tirzepatide", "retatrutide" ], "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "retrievalUrl": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "sourceDate": "2026-09-01", "retrievedAt": "2026-09-16", "payloadSha256": "bfb6cd2a11e3f8e20bedfeed0e0d554205c76dd83f473956deb82afc186e51cc", "pageCount": null, "locations": [ { "id": "compounded", "label": "Concerns with compounded versions of these drugs", "pages": [] }, { "id": "salts", "label": "Salt forms should not be used to compound semaglutide", "pages": [] }, { "id": "reports", "label": "Adverse events related to compounded versions of semaglutide and tirzepatide", "pages": [] }, { "id": "retatrutide", "label": "Retatrutide and cagrilintide cannot be used in compounding", "pages": [] } ] } ], "versionPath": "/peptides/semaglutide/source-notes/versions/1/" }, { "peptideSlug": "tirzepatide", "version": 1, "publishedAt": "2026-09-16", "reviewedAt": "2026-09-16", "scope": "Selected FDA safety communications, read alongside the separately preserved product-label account and human evidence review.", "findings": [ { "heading": "FDA revisited the psychiatric-safety warning", "text": "On January 13, 2026, FDA requested removal of the suicidal-behavior and ideation warning from Zepbound labeling after its review found no increased risk. 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Its registered outcomes include weight change, sleep-apnea and knee-osteoarthritis subsets. The retrieved record has no posted summary results; completion alone is not an efficacy finding.", "citations": [ { "sourceId": "TRIUMPH-1", "locationId": "identity" }, { "sourceId": "TRIUMPH-1", "locationId": "status" }, { "sourceId": "TRIUMPH-1", "locationId": "design" } ] }, { "heading": "Cardiovascular and kidney outcomes are still being studied", "text": "NCT06383390 is active, not recruiting, in its August 24 record. It lists cardiovascular and kidney composite endpoints, estimated enrollment of 10,000, and estimated completion in February 2029. No summary results are posted in the retrieved record.", "citations": [ { "sourceId": "TRIUMPH-OUTCOMES", "locationId": "identity" }, { "sourceId": "TRIUMPH-OUTCOMES", "locationId": "status" }, { "sourceId": "TRIUMPH-OUTCOMES", "locationId": "design" } ] } ], "remainingWork": [ "Match new obesity outcome publications and sponsor reports to their protocols before incorporating results; absence of registry results does not mean no results exist elsewhere.", "Complete full-text appraisal of the existing selected literature review and follow long-term outcome trials." ], "sources": [ { "id": "glp-unapproved", "title": "FDA concerns with unapproved GLP-1 drugs", "authority": "FDA", "kind": "web", "peptideSlugs": [ "semaglutide", "tirzepatide", "retatrutide" ], "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "retrievalUrl": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "sourceDate": "2026-09-01", "retrievedAt": "2026-09-16", "payloadSha256": "bfb6cd2a11e3f8e20bedfeed0e0d554205c76dd83f473956deb82afc186e51cc", "pageCount": null, "locations": [ { "id": "compounded", "label": "Concerns with compounded versions of these drugs", "pages": [] }, { "id": "salts", "label": "Salt forms should not be used to compound semaglutide", "pages": [] }, { "id": "reports", "label": "Adverse events related to compounded versions of semaglutide and tirzepatide", "pages": [] }, { "id": "retatrutide", "label": "Retatrutide and cagrilintide cannot be used in compounding", "pages": [] } ] }, { "id": "TRIUMPH-1", "title": "TRIUMPH-1 · NCT05929066", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "retatrutide" ], "url": "https://clinicaltrials.gov/study/NCT05929066", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT05929066", "sourceDate": "2026-08-21", "retrievedAt": "2026-09-16", "payloadSha256": "2a606fc27966954db54215572c5b8dce1fbe1d25910a88c0b4efebe1fda60795", "pageCount": null, "locations": [ { "id": "identity", "label": "protocolSection.identificationModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; hasResults", "pages": [] }, { "id": "design", "label": "protocolSection.designModule; protocolSection.outcomesModule.primaryOutcomes", "pages": [] } ] }, { "id": "TRIUMPH-OUTCOMES", "title": "TRIUMPH-OUTCOMES · NCT06383390", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "retatrutide" ], "url": "https://clinicaltrials.gov/study/NCT06383390", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT06383390", "sourceDate": "2026-08-24", "retrievedAt": "2026-09-16", "payloadSha256": "92fbfee77c8e9b0797c4cf847951faee64e617d3b1e940f2123711936eba886b", "pageCount": null, "locations": [ { "id": "identity", "label": "protocolSection.identificationModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; hasResults", "pages": [] }, { "id": "design", "label": "protocolSection.designModule; protocolSection.outcomesModule.primaryOutcomes", "pages": [] } ] } ], "versionPath": "/peptides/retatrutide/source-notes/versions/1/" }, { "peptideSlug": "bpc-157", "version": 1, "publishedAt": "2026-09-16", "reviewedAt": "2026-09-16", "scope": "Selected sections of FDA’s May 11, 2026 evaluation prepared for the July advisory meeting; findings remain attributed to that dated assessment.", "findings": [ { "heading": "FDA’s review focused on ulcerative colitis", "text": "FDA evaluated BPC-157 free base and acetate separately for ulcerative colitis. The briefing recommended against their inclusion on the 503A bulks list. It explicitly precedes a final agency determination; this summary does not report a final ruling.", "citations": [ { "sourceId": "bpc", "locationId": "scope" }, { "sourceId": "bpc", "locationId": "safety" } ] }, { "heading": "The human trial evidence was limited", "text": "FDA identified a 53-participant, two-week randomized study reported only in a meeting abstract. Missing endpoint, eligibility, statistical and follow-up details prevented it from supporting efficacy and safety conclusions for ulcerative colitis.", "citations": [ { "sourceId": "bpc", "locationId": "efficacy" } ] }, { "heading": "Formulation and duration limit extrapolation", "text": "The reviewed trial used a rectal enema, not the nominated suppository. FDA found no ulcerative-colitis studies using the proposed oral, subcutaneous, nasal or transdermal routes. These findings cannot establish effectiveness for tendon or sports injuries.", "citations": [ { "sourceId": "bpc", "locationId": "scope" }, { "sourceId": "bpc", "locationId": "efficacy" } ] }, { "heading": "Safety remains inadequately characterized", "text": "FDA described insufficient clinical safety information, limited long-term data and concerns involving peptide impurities, aggregation and immune responses. Its adverse-event reports could not establish causality.", "citations": [ { "sourceId": "bpc", "locationId": "safety" } ] } ], "remainingWork": [ "Check for a subsequent final FDA decision separately from the briefing and advisory process.", "Retrieve the original ulcerative-colitis report and appraise other human studies by indication, formulation and route." ], "sources": [ { "id": "bpc", "title": "FDA BPC-157 briefing for the July 2026 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "bpc-157" ], "url": "https://www.fda.gov/media/193343/download", "retrievalUrl": "https://www.fda.gov/media/193343/download", "sourceDate": "2026-05-11", "retrievedAt": "2026-09-16", "payloadSha256": "339602f311095bb9baa023f102186a659ea6871c3f5a4dc7f811036182764d14", "pageCount": 68, "locations": [ { "id": "scope", "label": "Briefing boundary and evaluation scope", "pages": [ 1, 5, 8, 9 ] }, { "id": "efficacy", "label": "Effectiveness evidence for ulcerative colitis", "pages": [ 25, 27, 28, 29 ] }, { "id": "safety", "label": "Safety conclusions and recommendation", "pages": [ 43, 44, 45, 46, 47 ] } ] } ], "versionPath": "/peptides/bpc-157/source-notes/versions/1/" }, { "peptideSlug": "ghk-cu", "version": 1, "publishedAt": "2026-09-16", "reviewedAt": "2026-09-16", "scope": "Route-specific FDA nomination and safety records; these do not constitute approval of a finished product or proof of clinical benefit.", "findings": [ { "heading": "FDA’s records distinguish non-injectable GHK-Cu", "text": "The May 14, 2026 nominations list restores GHK-Cu excluding injectable routes to Category 1, meaning under evaluation. FDA explains that a nominator clarified its withdrawal applied only to the injectable route.", "citations": [ { "sourceId": "ghk-list", "locationId": "routes" } ] }, { "heading": "Injectable concerns remain separately documented", "text": "FDA’s safety page lists injectable GHK-Cu among withdrawn nominations, with concerns about aggregation, peptide impurities and immune responses, and limited human safety data. It should not be described as currently in Category 2 on that basis.", "citations": [ { "sourceId": "bulk-safety", "locationId": "injectable" } ] }, { "heading": "What the next review could clarify", "text": "The May list announces an intention to consult the advisory committee before the end of February 2027 about potential inclusion on the 503A bulks list. An announced consultation is not a completed review or a finding of effectiveness.", "citations": [ { "sourceId": "ghk-list", "locationId": "routes" } ] } ], "remainingWork": [ "Verify any later committee materials or final agency action; keep injectable and non-injectable records separate.", "Appraise the full texts of topical and combination studies before drawing conclusions beyond their populations and formulations." ], "sources": [ { "id": "ghk-list", "title": "FDA 503A nominations list, May 14, 2026", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "ghk-cu" ], "url": "https://www.fda.gov/media/94155/download", "retrievalUrl": "https://www.fda.gov/media/94155/download", "sourceDate": "2026-05-14", "retrievedAt": "2026-09-16", "payloadSha256": "94f3353f1bdf65ac1800dfe747c5efdc33fa542f1ba40344a31e2fe286614415", "pageCount": 7, "locations": [ { "id": "routes", "label": "GHK-Cu correction and Category 1 entry", "pages": [ 1, 2, 3 ] } ] }, { "id": "bulk-safety", "title": "FDA bulk-substance safety concerns", "authority": "FDA", "kind": "web", "peptideSlugs": [ "ghk-cu" ], "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks", "retrievalUrl": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks", "sourceDate": "2026-04-22", "retrievedAt": "2026-09-16", "payloadSha256": "1a43f6d8b9da6b1fb5b2da83130882ec18e255f862c773d4cb636d67061c41cf", "pageCount": null, "locations": [ { "id": "injectable", "label": "Bulk drug substances nominated but withdrawn: GHK-Cu (for injectable routes of administration)", "pages": [] } ] } ], "versionPath": "/peptides/ghk-cu/source-notes/versions/1/" }, { "peptideSlug": "dulaglutide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sections of the November 16, 2022 FDA pediatric supplement review, separate from the original adult EMA assessment and later regulatory changes.", "findings": [ { "heading": "A dedicated pediatric trial", "text": "FDA’s 2022 review describes study GBGC in 154 participants aged 10–17 with type 2 diabetes. It compared two dulaglutide groups with placebo during a 26-week blinded period, followed by a 26-week open-label period. The extension is not another independent randomized trial.", "citations": [ { "sourceId": "dulaglutide-pediatric-2022", "locationId": "design" } ] }, { "heading": "The primary result concerned glucose control", "text": "The review supports a reduction in HbA1c versus placebo at week 26. Its prose and Table 2 disagree on the pooled point estimate, so this account does not select one silently. The primary endpoint was not weight loss or cardiovascular events.", "citations": [ { "sourceId": "dulaglutide-pediatric-2022", "locationId": "efficacy" } ] }, { "heading": "Safety findings retain the accompanying-treatment context", "text": "Gastrointestinal events were the most common treatment-emergent adverse events. FDA observed the greatest hypoglycemia risk among participants also using insulin. This small pediatric program cannot rule out uncommon or longer-term harms.", "citations": [ { "sourceId": "dulaglutide-pediatric-2022", "locationId": "safety" } ] }, { "heading": "The recommendation was specific to this supplement", "text": "The reviewer supported extending the glycemic-control indication to patients aged ten and older and discharging one pediatric study requirement. A separate requirement covering higher strengths remained outstanding in this November 2022 memo; its present status needs separate verification.", "citations": [ { "sourceId": "dulaglutide-pediatric-2022", "locationId": "decision" } ] } ], "remainingWork": [ "Reconcile the pooled point-estimate discrepancy against the statistical review and trial publication.", "Verify subsequent pediatric requirements and the current product label; the historical memo is not a current prescribing summary." ], "sources": [ { "id": "dulaglutide-pediatric-2022", "title": "FDA Trulicity pediatric supplement S-051 summary review", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "dulaglutide" ], "url": "https://www.fda.gov/media/164320/download", "retrievalUrl": "https://www.fda.gov/media/164320/download", "sourceDate": "2022-11-16", "retrievedAt": "2026-09-19", "payloadSha256": "9b49732f68af66f5a87de5e8f11e07adda26b2e0c01e2491b736d1909d62e555", "pageCount": 14, "locations": [ { "id": "design", "label": "Study GBGC design and population", "pages": [ 5, 6 ] }, { "id": "efficacy", "label": "Primary efficacy analysis and Table 2; inconsistent pooled point estimates", "pages": [ 7, 8 ] }, { "id": "safety", "label": "Safety interpretation and concomitant insulin", "pages": [ 9, 12 ] }, { "id": "decision", "label": "Review recommendations and outstanding requirement at that date", "pages": [ 12, 13 ] } ] } ], "versionPath": "/peptides/dulaglutide/source-notes/versions/1/" }, { "peptideSlug": "bpc-157", "version": 2, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.", "findings": [ { "heading": "FDA’s review focused on ulcerative colitis", "text": "FDA evaluated BPC-157 free base and acetate separately for ulcerative colitis. The briefing recommended against their inclusion on the 503A bulks list. It explicitly precedes a final agency determination; this summary does not report a final ruling.", "citations": [ { "sourceId": "bpc", "locationId": "scope" }, { "sourceId": "bpc", "locationId": "safety" } ] }, { "heading": "The human trial evidence was limited", "text": "FDA identified a 53-participant, two-week randomized study reported only in a meeting abstract. Missing endpoint, eligibility, statistical and follow-up details prevented it from supporting efficacy and safety conclusions for ulcerative colitis.", "citations": [ { "sourceId": "bpc", "locationId": "efficacy" } ] }, { "heading": "Formulation and duration limit extrapolation", "text": "The reviewed trial used a rectal enema, not the nominated suppository. FDA found no ulcerative-colitis studies using the proposed oral, subcutaneous, nasal or transdermal routes. These findings cannot establish effectiveness for tendon or sports injuries.", "citations": [ { "sourceId": "bpc", "locationId": "scope" }, { "sourceId": "bpc", "locationId": "efficacy" } ] }, { "heading": "Safety remains inadequately characterized", "text": "FDA described insufficient clinical safety information, limited long-term data and concerns involving peptide impurities, aggregation and immune responses. Its adverse-event reports could not establish causality.", "citations": [ { "sourceId": "bpc", "locationId": "safety" } ] }, { "heading": "Rectal-enema findings do not validate other formulations", "text": "The briefing distinguishes the studied rectal enema from the nominated suppository and other routes. FDA found no human pharmacokinetic data for oral, subcutaneous, nasal or transdermal administration in its reviewed sources.", "citations": [ { "sourceId": "bpc-157-pcac-20260919", "locationId": "finding-2" } ] }, { "heading": "Assay experiments are not human treatment studies", "text": "FDA identified laboratory plasma-metabolism reports used for anti-doping detection in which BPC-157 was not administered to people. Such work must not be counted as a clinical exposure study.", "citations": [ { "sourceId": "bpc-157-pcac-20260919", "locationId": "finding-3" } ] }, { "heading": "Reported adverse events cannot establish causation or incidence", "text": "FDA discussed injection-related reports but noted incomplete information and concomitant substances. Those reports neither prove that BPC-157 caused each event nor establish a reliable adverse-event rate.", "citations": [ { "sourceId": "bpc-157-pcac-20260919", "locationId": "finding-4" } ] } ], "remainingWork": [ "Check subsequent advisory records and any final FDA action separately from the staff briefing.", "Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review." ], "sources": [ { "id": "bpc", "title": "FDA BPC-157 briefing for the July 2026 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "bpc-157" ], "url": "https://www.fda.gov/media/193343/download", "retrievalUrl": "https://www.fda.gov/media/193343/download", "sourceDate": "2026-05-11", "retrievedAt": "2026-09-16", "payloadSha256": "339602f311095bb9baa023f102186a659ea6871c3f5a4dc7f811036182764d14", "pageCount": 68, "locations": [ { "id": "scope", "label": "Briefing boundary and evaluation scope", "pages": [ 1, 5, 8, 9 ] }, { "id": "efficacy", "label": "Effectiveness evidence for ulcerative colitis", "pages": [ 25, 27, 28, 29 ] }, { "id": "safety", "label": "Safety conclusions and recommendation", "pages": [ 43, 44, 45, 46, 47 ] } ] }, { "id": "bpc-157-pcac-20260919", "title": "FDA bpc-157 briefing for the July 2026 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "bpc-157" ], "url": "https://www.fda.gov/media/193343/download", "retrievalUrl": "https://www.fda.gov/media/193343/download", "sourceDate": "2026-07-23", "retrievedAt": "2026-09-19", "payloadSha256": "339602f311095bb9baa023f102186a659ea6871c3f5a4dc7f811036182764d14", "pageCount": 68, "locations": [ { "id": "finding-1", "label": "The ulcerative-colitis evidence was a short meeting abstract", "pages": [ 27, 28 ] }, { "id": "finding-2", "label": "Rectal-enema findings do not validate other formulations", "pages": [ 27, 40 ] }, { "id": "finding-3", "label": "Assay experiments are not human treatment studies", "pages": [ 40 ] }, { "id": "finding-4", "label": "Reported adverse events cannot establish causation or incidence", "pages": [ 41, 44 ] } ] } ], "versionPath": "/peptides/bpc-157/source-notes/versions/2/" }, { "peptideSlug": "emideltide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.", "findings": [ { "heading": "Different proposed uses have different evidence gaps", "text": "FDA’s July 2026 briefing assessed chronic insomnia, narcolepsy and opioid withdrawal separately. Small heterogeneous sleep studies and a single-person narcolepsy report did not establish durable clinical benefit.", "citations": [ { "sourceId": "emideltide-pcac-20260919", "locationId": "finding-1" } ] }, { "heading": "Withdrawal reports lacked robust controls", "text": "FDA described small open-label studies with no comparison group, inconsistent outcome methods and limited completion. Apparent short-term changes do not establish an effective maintenance treatment.", "citations": [ { "sourceId": "emideltide-pcac-20260919", "locationId": "finding-2" } ] }, { "heading": "The route mismatch is material", "text": "The clinical reports discussed intravenous administration, while the nomination proposed subcutaneous use. FDA reported no safety data for that proposed route and insufficient characterization of chronic intermittent use.", "citations": [ { "sourceId": "emideltide-pcac-20260919", "locationId": "finding-3" } ] }, { "heading": "A briefing proposal is not a final decision", "text": "FDA staff proposed against adding the nominated substances to the 503A bulks list, citing quality, effectiveness and safety gaps. The document explicitly precedes the final agency determination.", "citations": [ { "sourceId": "emideltide-pcac-20260919", "locationId": "finding-4" } ] } ], "remainingWork": [ "Check subsequent advisory records and any final FDA action separately from the staff briefing.", "Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review." ], "sources": [ { "id": "emideltide-pcac-20260919", "title": "FDA emideltide briefing for the July 2026 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "emideltide" ], "url": "https://www.fda.gov/media/193344/download", "retrievalUrl": "https://www.fda.gov/media/193344/download", "sourceDate": "2026-07-23", "retrievedAt": "2026-09-19", "payloadSha256": "6753532d72dd9366e35a5c3669ce7b2a6ffb6edbceac0ca4c963b1703f392906", "pageCount": 83, "locations": [ { "id": "finding-1", "label": "Different proposed uses have different evidence gaps", "pages": [ 32, 33, 34, 36 ] }, { "id": "finding-2", "label": "Withdrawal reports lacked robust controls", "pages": [ 38, 39 ] }, { "id": "finding-3", "label": "The route mismatch is material", "pages": [ 53, 56 ] }, { "id": "finding-4", "label": "A briefing proposal is not a final decision", "pages": [ 1, 53, 56 ] } ] } ], "versionPath": "/peptides/emideltide/source-notes/versions/1/" }, { "peptideSlug": "epitalon", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.", "findings": [ { "heading": "Melatonin measurements do not establish an insomnia benefit", "text": "FDA’s July 2026 briefing found no studies evaluating the nominated substances in patients with insomnia. Changes in melatonin or its metabolites were not accompanied by clinical outcomes establishing that proposed use.", "citations": [ { "sourceId": "epitalon-pcac-20260919", "locationId": "finding-1" } ] }, { "heading": "Human exposure is different from an adequate safety study", "text": "The briefing describes a 20-person exposure report without safety data and an abstract making a safety claim without essential methods. FDA also notes that it could not evaluate one Russian-language full article in English.", "citations": [ { "sourceId": "epitalon-pcac-20260919", "locationId": "finding-2" } ] }, { "heading": "No reported events is not proof of safety", "text": "FDA’s cited adverse-event searches retrieved no reports, but the briefing explains voluntary-reporting and information limits. It separately found insufficient clinical safety data, especially for the proposed subcutaneous route.", "citations": [ { "sourceId": "epitalon-pcac-20260919", "locationId": "finding-3" } ] }, { "heading": "Preclinical findings leave unresolved questions", "text": "FDA considered the animal studies too limited in duration and design to characterize genotoxic or carcinogenic potential. Mechanistic concerns in the briefing are not proof that epitalon causes cancer in people.", "citations": [ { "sourceId": "epitalon-pcac-20260919", "locationId": "finding-4" } ] } ], "remainingWork": [ "Check subsequent advisory records and any final FDA action separately from the staff briefing.", "Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review." ], "sources": [ { "id": "epitalon-pcac-20260919", "title": "FDA epitalon briefing for the July 2026 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "epitalon" ], "url": "https://www.fda.gov/media/193345/download", "retrievalUrl": "https://www.fda.gov/media/193345/download", "sourceDate": "2026-07-23", "retrievedAt": "2026-09-19", "payloadSha256": "0dbe9252cdea634f279f9a8166f45ce561c43fb07c6eff517a9d15593f95931f", "pageCount": 64, "locations": [ { "id": "finding-1", "label": "Melatonin measurements do not establish an insomnia benefit", "pages": [ 40 ] }, { "id": "finding-2", "label": "Human exposure is different from an adequate safety study", "pages": [ 36, 37 ] }, { "id": "finding-3", "label": "No reported events is not proof of safety", "pages": [ 36, 38 ] }, { "id": "finding-4", "label": "Preclinical findings leave unresolved questions", "pages": [ 40 ] } ] } ], "versionPath": "/peptides/epitalon/source-notes/versions/1/" }, { "peptideSlug": "kpv", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.", "findings": [ { "heading": "The nominated evidence was not a human treatment program", "text": "FDA’s July 2026 briefing found that the submitted references concerned animal work or skin permeation using human cadaver skin. These are distinct from administering KPV to living participants.", "citations": [ { "sourceId": "kpv-pcac-20260919", "locationId": "finding-1" } ] }, { "heading": "The absence claim has a defined source and scope", "text": "FDA reported finding no clinical studies supporting KPV for wound healing or inflammatory conditions in its evaluation. This is an attributed search finding, not proof that no relevant record could exist anywhere.", "citations": [ { "sourceId": "kpv-pcac-20260919", "locationId": "finding-2" } ] }, { "heading": "Safety remains uncharacterized in the reviewed evidence", "text": "The briefing found no human pharmacokinetic or clinical safety studies. Its adverse-event search retrieved no reports, but FDA explicitly explains why passive reporting cannot establish safety.", "citations": [ { "sourceId": "kpv-pcac-20260919", "locationId": "finding-3" } ] }, { "heading": "Quality questions matter even for a short peptide", "text": "FDA identified missing characterization and formulation data and insufficient information about aggregation and immunogenicity. A three-amino-acid sequence alone did not resolve those product-level questions.", "citations": [ { "sourceId": "kpv-pcac-20260919", "locationId": "finding-4" } ] } ], "remainingWork": [ "Check subsequent advisory records and any final FDA action separately from the staff briefing.", "Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review." ], "sources": [ { "id": "kpv-pcac-20260919", "title": "FDA kpv briefing for the July 2026 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "kpv" ], "url": "https://www.fda.gov/media/193346/download", "retrievalUrl": "https://www.fda.gov/media/193346/download", "sourceDate": "2026-07-23", "retrievedAt": "2026-09-19", "payloadSha256": "0253b86534700fc72a48cccab7b10c19201102da831ef7a8a28e8dab09fea254", "pageCount": 38, "locations": [ { "id": "finding-1", "label": "The nominated evidence was not a human treatment program", "pages": [ 20 ] }, { "id": "finding-2", "label": "The absence claim has a defined source and scope", "pages": [ 20, 21 ] }, { "id": "finding-3", "label": "Safety remains uncharacterized in the reviewed evidence", "pages": [ 26 ] }, { "id": "finding-4", "label": "Quality questions matter even for a short peptide", "pages": [ 27, 28 ] } ] } ], "versionPath": "/peptides/kpv/source-notes/versions/1/" }, { "peptideSlug": "mots-c", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.", "findings": [ { "heading": "The agency assessment found preclinical rather than treatment evidence", "text": "FDA’s July 2026 briefing did not identify studies administering the nominated MOTS-c substances to humans. It distinguished that absence from rodent and cell studies relevant to proposed metabolic and bone effects.", "citations": [ { "sourceId": "mots-c-pcac-20260919", "locationId": "finding-1" } ] }, { "heading": "Bone-cell findings do not establish fracture prevention", "text": "The discussed bone experiments used cultured cells and rodent models. They do not demonstrate reduced fractures or a clinical osteoporosis benefit in people.", "citations": [ { "sourceId": "mots-c-pcac-20260919", "locationId": "finding-2" } ] }, { "heading": "Mechanistic uncertainty limits extrapolation", "text": "FDA noted missing in-vivo dose-response evaluation and uncertainty about the molecular targets. It considered the clinical relevance of the preclinical findings unresolved.", "citations": [ { "sourceId": "mots-c-pcac-20260919", "locationId": "finding-3" } ] }, { "heading": "The recommendation concerns the nominated substances", "text": "The briefing weighed against inclusion of MOTS-c free base and acetate on the 503A bulks list and described characterization gaps. This staff proposal is distinct from a final agency action or an assessment of every related analogue.", "citations": [ { "sourceId": "mots-c-pcac-20260919", "locationId": "finding-4" } ] } ], "remainingWork": [ "Check subsequent advisory records and any final FDA action separately from the staff briefing.", "Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review." ], "sources": [ { "id": "mots-c-pcac-20260919", "title": "FDA mots-c briefing for the July 2026 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "mots-c" ], "url": "https://www.fda.gov/media/193347/download", "retrievalUrl": "https://www.fda.gov/media/193347/download", "sourceDate": "2026-07-23", "retrievedAt": "2026-09-19", "payloadSha256": "5eec34a77c0dc06ffd0c570241b487137b5ce9b9200543ff19187d8f539a45da", "pageCount": 44, "locations": [ { "id": "finding-1", "label": "The agency assessment found preclinical rather than treatment evidence", "pages": [ 25, 31 ] }, { "id": "finding-2", "label": "Bone-cell findings do not establish fracture prevention", "pages": [ 24, 31 ] }, { "id": "finding-3", "label": "Mechanistic uncertainty limits extrapolation", "pages": [ 25, 31 ] }, { "id": "finding-4", "label": "The recommendation concerns the nominated substances", "pages": [ 1, 32 ] } ] } ], "versionPath": "/peptides/mots-c/source-notes/versions/1/" }, { "peptideSlug": "semax", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.", "findings": [ { "heading": "The 2026 assessment did not establish the nominated uses", "text": "FDA’s briefing found insufficient evidence for cerebral ischemia, migraine and trigeminal neuralgia. The reviewed clinical references had limited methods and outcome information; this is the agency’s scoped assessment.", "citations": [ { "sourceId": "semax-pcac-20260919", "locationId": "finding-1" } ] }, { "heading": "Uncontrolled symptom reports have limited interpretability", "text": "For migraine and trigeminal neuralgia, FDA described small uncontrolled studies with unclear rating scales and incomplete reporting. Before-and-after changes alone cannot distinguish treatment effects from other explanations.", "citations": [ { "sourceId": "semax-pcac-20260919", "locationId": "finding-2" } ] }, { "heading": "Nonclinical effects are not established clinical benefits", "text": "The briefing discusses neurological and other effects in rodents but poorly understood mechanisms and missing toxicology relevant to the proposed subcutaneous route. Those findings cannot be promoted into demonstrated human efficacy.", "citations": [ { "sourceId": "semax-pcac-20260919", "locationId": "finding-3" } ] }, { "heading": "Form and safety reporting remain important gaps", "text": "Clinical references often did not specify free base versus salt, and many did not discuss safety. FDA raised questions about bleeding and injectable-product immunogenicity; these are concerns requiring evidence, not quantified risks established by these reports.", "citations": [ { "sourceId": "semax-pcac-20260919", "locationId": "finding-4" } ] } ], "remainingWork": [ "Check subsequent advisory records and any final FDA action separately from the staff briefing.", "Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review." ], "sources": [ { "id": "semax-pcac-20260919", "title": "FDA semax briefing for the July 2026 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "semax" ], "url": "https://www.fda.gov/media/193348/download", "retrievalUrl": "https://www.fda.gov/media/193348/download", "sourceDate": "2026-07-23", "retrievedAt": "2026-09-19", "payloadSha256": "391f5586c1af1cf08d96d1a070c3800786e4e97b6eac069ff94e6fd2c5161599", "pageCount": 69, "locations": [ { "id": "finding-1", "label": "The 2026 assessment did not establish the nominated uses", "pages": [ 29 ] }, { "id": "finding-2", "label": "Uncontrolled symptom reports have limited interpretability", "pages": [ 26, 28 ] }, { "id": "finding-3", "label": "Nonclinical effects are not established clinical benefits", "pages": [ 37 ] }, { "id": "finding-4", "label": "Form and safety reporting remain important gaps", "pages": [ 37, 41 ] } ] } ], "versionPath": "/peptides/semax/source-notes/versions/1/" }, { "peptideSlug": "tb-500", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.", "findings": [ { "heading": "The fragment is not the full-length peptide", "text": "FDA’s July 2026 briefing defines TB-500 as an N-acetylated seven-amino-acid fragment of the 43-amino-acid thymosin beta-4. Results for the full-length molecule or an unacetylated fragment cannot automatically be assigned to TB-500.", "citations": [ { "sourceId": "tb-500-pcac-20260919", "locationId": "finding-1" } ] }, { "heading": "Wound-healing claims lacked clinical evidence in the assessment", "text": "FDA reported no identified clinical information showing administration of the nominated TB-500 substances to patients for wound healing or another condition. This remains a dated, source-specific assessment.", "citations": [ { "sourceId": "tb-500-pcac-20260919", "locationId": "finding-2" } ] }, { "heading": "Product reports do not substitute for a safety study", "text": "The briefing found no clinical pharmacokinetic studies and described reports involving blended TB-500/BPC-157 products without safety assessments. These do not establish a TB-500-specific safety profile.", "citations": [ { "sourceId": "tb-500-pcac-20260919", "locationId": "finding-3" } ] }, { "heading": "The toxicology gap is separate from efficacy", "text": "FDA reported no identified nonclinical toxicity studies for the nominated free base or acetate. That missing evidence should not be interpreted as either demonstrated safety or proof of a specific human harm.", "citations": [ { "sourceId": "tb-500-pcac-20260919", "locationId": "finding-4" } ] } ], "remainingWork": [ "Check subsequent advisory records and any final FDA action separately from the staff briefing.", "Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review." ], "sources": [ { "id": "tb-500-pcac-20260919", "title": "FDA tb-500 briefing for the July 2026 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "tb-500" ], "url": "https://www.fda.gov/media/193349/download", "retrievalUrl": "https://www.fda.gov/media/193349/download", "sourceDate": "2026-07-23", "retrievedAt": "2026-09-19", "payloadSha256": "973cffba12fec26da77d67b3e08604500b754eaa48d15912acb9596f3090b5a4", "pageCount": 41, "locations": [ { "id": "finding-1", "label": "The fragment is not the full-length peptide", "pages": [ 25 ] }, { "id": "finding-2", "label": "Wound-healing claims lacked clinical evidence in the assessment", "pages": [ 24 ] }, { "id": "finding-3", "label": "Product reports do not substitute for a safety study", "pages": [ 30, 31 ] }, { "id": "finding-4", "label": "The toxicology gap is separate from efficacy", "pages": [ 30 ] } ] } ], "versionPath": "/peptides/tb-500/source-notes/versions/1/" }, { "peptideSlug": "cjc-1295", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.", "findings": [ { "heading": "The tested substance may not match every marketed name", "text": "FDA’s December 2024 briefing considered several CJC-1295 and DAC forms separately. The limited clinical reports appeared to involve a DAC active moiety with incompletely specified form; other nominated forms lacked equivalent clinical information.", "citations": [ { "sourceId": "cjc-1295-pcac-20260919", "locationId": "finding-1" } ] }, { "heading": "Hormone changes in healthy adults did not establish treatment benefit", "text": "The reviewed reports involved healthy adults, not patients with growth-hormone deficiency, and did not measure key clinical outcomes such as body-composition change or height velocity. FDA did not consider them evidence of effectiveness for that condition.", "citations": [ { "sourceId": "cjc-1295-pcac-20260919", "locationId": "finding-2" } ] }, { "heading": "The safety sample was small and mostly short exposure", "text": "FDA described 63 exposed participants, predominantly men, with most receiving a single exposure. That evidence did not characterize long-term safety or pediatric use.", "citations": [ { "sourceId": "cjc-1295-pcac-20260919", "locationId": "finding-3" } ] }, { "heading": "Adverse events need careful attribution", "text": "The briefing describes injection-site and systemic reactions, including heart-rate and blood-pressure effects. It also discusses a death attributed to coronary disease in an unpublished trial account; the document does not prove CJC-1295 caused that death.", "citations": [ { "sourceId": "cjc-1295-pcac-20260919", "locationId": "finding-4" } ] } ], "remainingWork": [ "Check subsequent advisory records and any final FDA action separately from the staff briefing.", "Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review." ], "sources": [ { "id": "cjc-1295-pcac-20260919", "title": "FDA cjc-1295 briefing for the December 2024 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "cjc-1295" ], "url": "https://www.fda.gov/media/183819/download", "retrievalUrl": "https://www.fda.gov/media/183819/download", "sourceDate": "2024-12-04", "retrievedAt": "2026-09-19", "payloadSha256": "202fa022933ef27241c6e19f2156ca764854ccf4a7286e0fe1f1b6b56df39506", "pageCount": 72, "locations": [ { "id": "finding-1", "label": "The tested substance may not match every marketed name", "pages": [ 46, 50 ] }, { "id": "finding-2", "label": "Hormone changes in healthy adults did not establish treatment benefit", "pages": [ 50 ] }, { "id": "finding-3", "label": "The safety sample was small and mostly short exposure", "pages": [ 46 ] }, { "id": "finding-4", "label": "Adverse events need careful attribution", "pages": [ 46 ] } ] } ], "versionPath": "/peptides/cjc-1295/source-notes/versions/1/" }, { "peptideSlug": "ipamorelin", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.", "findings": [ { "heading": "The pharmacology study does not establish chronic treatment benefit", "text": "FDA’s October 2024 briefing describes intravenous pharmacology in healthy male volunteers. It found no corresponding pharmacokinetic or pharmacodynamic evidence for the proposed subcutaneous route.", "citations": [ { "sourceId": "ipamorelin-pcac-20260919", "locationId": "finding-1" } ] }, { "heading": "The surgical trial studied a different clinical setting", "text": "The safety discussion concerns hospitalized adults after bowel surgery, not a general wellness population or chronic growth-hormone-deficiency treatment. The formulation was not fully specified in the clinical report.", "citations": [ { "sourceId": "ipamorelin-pcac-20260919", "locationId": "finding-2" } ] }, { "heading": "Serious events were reported, with causality unresolved", "text": "FDA describes serious postoperative events and two deaths among ipamorelin-treated participants. It explicitly states that their relationship to ipamorelin was unclear, while considering the overall findings a safety concern.", "citations": [ { "sourceId": "ipamorelin-pcac-20260919", "locationId": "finding-3" } ] }, { "heading": "Product quality is part of the uncertainty", "text": "FDA raised questions about impurities, aggregates, endotoxins and immunogenicity for the nominated substances. Its staff recommendation against 503A-list inclusion is a pre-decision assessment, not itself a final agency ruling.", "citations": [ { "sourceId": "ipamorelin-pcac-20260919", "locationId": "finding-4" } ] } ], "remainingWork": [ "Check subsequent advisory records and any final FDA action separately from the staff briefing.", "Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review." ], "sources": [ { "id": "ipamorelin-pcac-20260919", "title": "FDA ipamorelin briefing for the October 2024 advisory meeting", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "ipamorelin" ], "url": "https://www.fda.gov/media/182088/download", "retrievalUrl": "https://www.fda.gov/media/182088/download", "sourceDate": "2024-10-29", "retrievedAt": "2026-09-19", "payloadSha256": "751d3a46471342fd83a14540bd4ed7fb2f802df89c71f1792c4d0abb2b7c671e", "pageCount": 55, "locations": [ { "id": "finding-1", "label": "The pharmacology study does not establish chronic treatment benefit", "pages": [ 35 ] }, { "id": "finding-2", "label": "The surgical trial studied a different clinical setting", "pages": [ 35, 37 ] }, { "id": "finding-3", "label": "Serious events were reported, with causality unresolved", "pages": [ 37 ] }, { "id": "finding-4", "label": "Product quality is part of the uncertainty", "pages": [ 1, 40 ] } ] } ], "versionPath": "/peptides/ipamorelin/source-notes/versions/1/" }, { "peptideSlug": "amycretin", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.", "findings": [ { "heading": "The injection and oral studies are separate", "text": "NCT06064006 records 125 participants in a completed study of subcutaneous NNC0487-0111. NCT06049329 records a separate 36-participant oral study in Japanese men. These populations and routes should not be pooled as one trial.", "citations": [ { "sourceId": "nct06064006-20260919", "locationId": "design" }, { "sourceId": "nct06049329-20260919", "locationId": "design" } ] }, { "heading": "The registered primary questions concerned adverse events", "text": "Both records list treatment-emergent adverse events as primary outcomes, with different observation windows across study parts. A weight change reported elsewhere is not automatically the primary endpoint of either registered study.", "citations": [ { "sourceId": "nct06064006-20260919", "locationId": "outcomes" }, { "sourceId": "nct06049329-20260919", "locationId": "outcomes" } ] }, { "heading": "Enrollment was selective", "text": "The subcutaneous study enrolled adults aged 18–55 within a specified BMI range and excluded diabetic-range HbA1c. The oral study was restricted to Japanese men. These designs do not establish effects across all ages, diabetes populations or demographic groups.", "citations": [ { "sourceId": "nct06064006-20260919", "locationId": "eligibility" }, { "sourceId": "nct06049329-20260919", "locationId": "eligibility" } ] }, { "heading": "Completion does not supply registry results", "text": "Both retrieved records are marked completed but contain no posted summary-results section. This is a registry-specific observation as of September 19, 2026, not a claim that trial publications or other reports do not exist.", "citations": [ { "sourceId": "nct06064006-20260919", "locationId": "status" }, { "sourceId": "nct06049329-20260919", "locationId": "status" } ] } ], "remainingWork": [ "Match oral and subcutaneous publications to exact protocols and reconcile their analysis populations.", "Review later trials and result postings without treating these selected records as a complete development inventory." ], "sources": [ { "id": "nct06049329-20260919", "title": "A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "amycretin" ], "url": "https://clinicaltrials.gov/study/NCT06049329", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT06049329", "sourceDate": "2025-03-05", "retrievedAt": "2026-09-19", "payloadSha256": "bcedaf5fb0ab31b31f1194f4f1e878a5ef0f74262c587127a87fffc8dfe68b1f", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] }, { "id": "nct06064006-20260919", "title": "A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "amycretin" ], "url": "https://clinicaltrials.gov/study/NCT06064006", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT06064006", "sourceDate": "2025-11-19", "retrievedAt": "2026-09-19", "payloadSha256": "07b607555cf7f16ab5bfedbe4a491fd148e8c233c5bc46f36ba9be330e301658", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] } ], "versionPath": "/peptides/amycretin/source-notes/versions/1/" }, { "peptideSlug": "cagrilintide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.", "findings": [ { "heading": "The monotherapy study used a pooled placebo group", "text": "NCT03856047 enrolled 706 participants and tested five cagrilintide groups plus liraglutide over 26 weeks. The six corresponding placebo groups were pooled for analysis; they are not six independent confirmatory studies.", "citations": [ { "sourceId": "nct03856047-20260919", "locationId": "design" }, { "sourceId": "nct03856047-20260919", "locationId": "flow" } ] }, { "heading": "Observed weight changes and modeled comparisons differ", "text": "The posted primary table reports mean weight changes of −6.1% to −10.8% across cagrilintide groups and −3.0% for pooled placebo. Its descriptive values use the in-trial period, while statistical comparisons use treatment-adherent data and missing-data methods; these estimates should not be mixed.", "citations": [ { "sourceId": "nct03856047-20260919", "locationId": "results" } ] }, { "heading": "CagriSema evidence concerns a combination", "text": "NCT04982575 enrolled 92 participants with type 2 diabetes and compared combination therapy with its individual components. Its primary comparison was 32-week HbA1c change for cagrilintide plus semaglutide versus semaglutide, not proof that cagrilintide alone produced the combination’s result.", "citations": [ { "sourceId": "nct04982575-20260919", "locationId": "design" }, { "sourceId": "nct04982575-20260919", "locationId": "outcomes" } ] }, { "heading": "An outcome denominator is not total enrollment", "text": "The combination study’s primary registry table includes 30 evaluable participants in each of the two compared groups, within a three-arm trial. Its selected diabetes population and background medication also differ from the monotherapy weight study.", "citations": [ { "sourceId": "nct04982575-20260919", "locationId": "results" }, { "sourceId": "nct04982575-20260919", "locationId": "eligibility" } ] } ], "remainingWork": [ "Appraise later monotherapy and CagriSema reports separately, including discontinuation and safety denominators.", "Reconcile primary-paper estimates with the registry’s in-trial versus treatment-adherent analyses." ], "sources": [ { "id": "nct03856047-20260919", "title": "Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "cagrilintide" ], "url": "https://clinicaltrials.gov/study/NCT03856047", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT03856047", "sourceDate": "2024-07-05", "retrievedAt": "2026-09-19", "payloadSha256": "2e186b55cc1c7724160d5c5cc0494fb1212780b5256a8046b8cf2f9ee8bcba90", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "flow", "label": "resultsSection.participantFlowModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] } ] }, { "id": "nct04982575-20260919", "title": "Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "cagrilintide" ], "url": "https://clinicaltrials.gov/study/NCT04982575", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT04982575", "sourceDate": "2025-12-23", "retrievedAt": "2026-09-19", "payloadSha256": "a61acea6c5dc1ca1ffd4bbb5124d95d533212e08a70d2696203e47f78316716a", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] } ] } ], "versionPath": "/peptides/cagrilintide/source-notes/versions/1/" }, { "peptideSlug": "maridebart-cafraglutide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.", "findings": [ { "heading": "The first study included an open-label part", "text": "Although NCT04478708 has an overall masked-trial designation, its participant-flow description says parts A and B were randomized and blinded while part C was open-label. Treating every participant as part of the same blinded comparison would misdescribe the evidence.", "citations": [ { "sourceId": "nct04478708-20260919", "locationId": "flow" }, { "sourceId": "nct04478708-20260919", "locationId": "design" } ] }, { "heading": "Posted phase 1 results emphasize exposure and safety", "text": "The completed 110-participant phase 1 record posts pharmacokinetic, adverse-event and antibody outcomes. Its results table does not contain a body-weight outcome, so a published weight estimate requires its separate source and analysis context.", "citations": [ { "sourceId": "nct04478708-20260919", "locationId": "design" }, { "sourceId": "nct04478708-20260919", "locationId": "results" } ] }, { "heading": "The phase 2 study asks a longer-term weight question", "text": "NCT05669599 records 592 participants across cohorts with and without type 2 diabetes. The registered primary endpoint is percentage body-weight change at week 52; the total enrollment is not a single outcome-analysis denominator.", "citations": [ { "sourceId": "nct05669599-20260919", "locationId": "design" }, { "sourceId": "nct05669599-20260919", "locationId": "outcomes" }, { "sourceId": "nct05669599-20260919", "locationId": "eligibility" } ] }, { "heading": "The larger trial lacks posted registry results in this snapshot", "text": "The phase 2 record is marked completed, with a January 20, 2026 last-posted update, but no summary-results section in the retrieved payload. That does not invalidate or replace separately published clinical reports.", "citations": [ { "sourceId": "nct05669599-20260919", "locationId": "status" } ] } ], "remainingWork": [ "Appraise the phase 1 and phase 2 publications, including weight outcomes absent from these registry results.", "Reconcile longer follow-up and adverse-event reporting across blinded and open-label parts." ], "sources": [ { "id": "nct04478708-20260919", "title": "Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "maridebart-cafraglutide" ], "url": "https://clinicaltrials.gov/study/NCT04478708", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT04478708", "sourceDate": "2025-12-10", "retrievedAt": "2026-09-19", "payloadSha256": "70f00f3032e9c27fe1160ddda7e00030ce4b6d55ad7ff7e8032fc8a04a92e8ef", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "flow", "label": "resultsSection.participantFlowModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] } ] }, { "id": "nct05669599-20260919", "title": "Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "maridebart-cafraglutide" ], "url": "https://clinicaltrials.gov/study/NCT05669599", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT05669599", "sourceDate": "2026-01-20", "retrievedAt": "2026-09-19", "payloadSha256": "9e9f041791a3a6a56e9849cd26473df206cb7e8a414648d702bbdd97761f2bea", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] } ], "versionPath": "/peptides/maridebart-cafraglutide/source-notes/versions/1/" }, { "peptideSlug": "mazdutide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.", "findings": [ { "heading": "Two phase 2 records concern different programs", "text": "NCT04904913 describes a 328-participant Chinese study of IBI362 with a 24-week weight endpoint. NCT06124807 describes a separate 179-participant LY3305677 study with a 32-week primary endpoint and 48-week follow-up. Their results are not interchangeable.", "citations": [ { "sourceId": "nct04904913-20260919", "locationId": "design" }, { "sourceId": "nct04904913-20260919", "locationId": "outcomes" }, { "sourceId": "nct06124807-20260919", "locationId": "design" }, { "sourceId": "nct06124807-20260919", "locationId": "outcomes" } ] }, { "heading": "The later record includes posted weight results", "text": "The LY3305677 registry reports modeled mean weight changes of −7.33%, −15.6% and −18.1% across the three active groups versus −0.85% for placebo at week 32. These are changes from baseline in that study, not placebo-adjusted percentages or a cross-drug ranking.", "citations": [ { "sourceId": "nct06124807-20260919", "locationId": "results" } ] }, { "heading": "Longer follow-up involved attrition", "text": "The same registry lists 179 participants starting and 128 completing the study. Its repeated-measures estimates should not be mistaken for measurements observed in every participant at every visit; adverse events were among several discontinuation reasons.", "citations": [ { "sourceId": "nct06124807-20260919", "locationId": "flow" }, { "sourceId": "nct06124807-20260919", "locationId": "results" } ] }, { "heading": "Result availability differs between the two records", "text": "The retrieved Chinese phase 2 record has no posted summary-results section, while the LY3305677 record does. Neither registry entry alone establishes the current authorization status in any jurisdiction.", "citations": [ { "sourceId": "nct04904913-20260919", "locationId": "status" }, { "sourceId": "nct06124807-20260919", "locationId": "status" } ] } ], "remainingWork": [ "Reconcile Chinese and international trial families and current jurisdiction-specific regulatory documents.", "Appraise original publications and analysis plans, including missing-data assumptions and safety outcomes." ], "sources": [ { "id": "nct04904913-20260919", "title": "A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "mazdutide" ], "url": "https://clinicaltrials.gov/study/NCT04904913", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT04904913", "sourceDate": "2025-11-17", "retrievedAt": "2026-09-19", "payloadSha256": "17c6c04046246d485b210ec2cb9946d088d8900d75328bba03e1f36b8da05d53", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] }, { "id": "nct06124807-20260919", "title": "A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "mazdutide" ], "url": "https://clinicaltrials.gov/study/NCT06124807", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT06124807", "sourceDate": "2026-04-21", "retrievedAt": "2026-09-19", "payloadSha256": "d0ae75ea6041b13d872f7113133b4e3280c8ef42504e8b51bab39c9fabea9d30", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "flow", "label": "resultsSection.participantFlowModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] } ], "versionPath": "/peptides/mazdutide/source-notes/versions/1/" }, { "peptideSlug": "pemvidutide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.", "findings": [ { "heading": "MOMENTUM studied weight over 48 weeks", "text": "NCT05295875 records 391 participants in a randomized, blinded, placebo-controlled obesity study. Its primary endpoint is relative percentage change in body weight at week 48; metabolic measures and adverse events appear separately.", "citations": [ { "sourceId": "nct05295875-20260919", "locationId": "design" }, { "sourceId": "nct05295875-20260919", "locationId": "outcomes" } ] }, { "heading": "IMPACT asks a liver-disease question", "text": "NCT05989711 records 212 participants in a separate placebo-controlled study of non-cirrhotic steatohepatitis. Its primary endpoints include 24-week histological resolution without fibrosis worsening and fibrosis improvement without disease worsening.", "citations": [ { "sourceId": "nct05989711-20260919", "locationId": "design" }, { "sourceId": "nct05989711-20260919", "locationId": "outcomes" } ] }, { "heading": "Liver biopsy and imaging endpoints should remain distinct", "text": "IMPACT lists MRI-measured liver fat as a secondary outcome alongside the biopsy-based primary endpoints. Less liver fat on imaging is not, by itself, the same finding as improved fibrosis or fewer clinical liver complications.", "citations": [ { "sourceId": "nct05989711-20260919", "locationId": "outcomes" } ] }, { "heading": "Completed records still need a separate results source", "text": "Both records are marked completed, but neither retrieved payload contains posted summary results. The last-posted updates are November 29, 2023 for MOMENTUM and May 18, 2026 for IMPACT; publications must be matched and appraised separately.", "citations": [ { "sourceId": "nct05295875-20260919", "locationId": "status" }, { "sourceId": "nct05989711-20260919", "locationId": "status" } ] } ], "remainingWork": [ "Retrieve and appraise MOMENTUM and IMPACT results with their original protocols and analysis plans.", "Keep weight, biopsy-based liver outcomes and imaging measures distinct; exclude unrelated drugs sharing the ALT-801 code." ], "sources": [ { "id": "nct05295875-20260919", "title": "Efficacy and Safety of ALT-801 in the Treatment of Obesity", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "pemvidutide" ], "url": "https://clinicaltrials.gov/study/NCT05295875", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT05295875", "sourceDate": "2023-11-29", "retrievedAt": "2026-09-19", "payloadSha256": "8df524b208735c78d68b871c884de78d0354ddbaf2cede1f07ed1932c0eabbcf", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] }, { "id": "nct05989711-20260919", "title": "IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "pemvidutide" ], "url": "https://clinicaltrials.gov/study/NCT05989711", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT05989711", "sourceDate": "2026-05-18", "retrievedAt": "2026-09-19", "payloadSha256": "479c36b141fd86c8fae6746a1bc773861ad9f2788575ad5828b2e74885222bb0", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] } ], "versionPath": "/peptides/pemvidutide/source-notes/versions/1/" }, { "peptideSlug": "petrelintide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.", "findings": [ { "heading": "ZUPREME 1 excludes diabetes", "text": "NCT06662539 records 493 participants in a placebo-controlled phase 2 study of overweight or obesity. The eligibility criteria exclude diabetes and diabetic-range HbA1c, defining a different population from the diabetes program.", "citations": [ { "sourceId": "nct06662539-20260919", "locationId": "design" }, { "sourceId": "nct06662539-20260919", "locationId": "eligibility" } ] }, { "heading": "ZUPREME 2 includes specified background diabetes treatment", "text": "NCT06926842 records 221 participants with type 2 diabetes treated with stable metformin, with or without an SGLT2 inhibitor. That background matters when interpreting glycemic or safety findings eventually reported.", "citations": [ { "sourceId": "nct06926842-20260919", "locationId": "design" }, { "sourceId": "nct06926842-20260919", "locationId": "eligibility" } ] }, { "heading": "Both primary endpoints concern weight at 28 weeks", "text": "Both records specify percentage body-weight change through week 28. This endpoint does not directly measure cardiovascular events, sustained benefit after stopping treatment, or every obesity-related complication.", "citations": [ { "sourceId": "nct06662539-20260919", "locationId": "outcomes" }, { "sourceId": "nct06926842-20260919", "locationId": "outcomes" } ] }, { "heading": "The status updates are not efficacy results", "text": "Both retrieved records are marked completed, but neither includes posted summary results. ZUPREME 2 was last updated on September 9, 2026. Any effect estimate needs a separate results source rather than being inferred from completion.", "citations": [ { "sourceId": "nct06662539-20260919", "locationId": "status" }, { "sourceId": "nct06926842-20260919", "locationId": "status" } ] } ], "remainingWork": [ "Match ZUPREME publications or subsequent registry results to each protocol before adding effect estimates.", "Review durability, discontinuation, gastrointestinal events and other safety findings in the diabetes and non-diabetes populations separately." ], "sources": [ { "id": "nct06662539-20260919", "title": "Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "petrelintide" ], "url": "https://clinicaltrials.gov/study/NCT06662539", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT06662539", "sourceDate": "2026-03-23", "retrievedAt": "2026-09-19", "payloadSha256": "a2d36b0b87f5de73bac31586f05407a69f07b01021771b76fc63cd04020bf763", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] }, { "id": "nct06926842-20260919", "title": "Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "petrelintide" ], "url": "https://clinicaltrials.gov/study/NCT06926842", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT06926842", "sourceDate": "2026-09-09", "retrievedAt": "2026-09-19", "payloadSha256": "12627b63a37b7c06a1d1772d78953ac7aef94b809c2be4b848f05d407fa796a3", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] } ], "versionPath": "/peptides/petrelintide/source-notes/versions/1/" }, { "peptideSlug": "retatrutide", "version": 2, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal. Earlier dated FDA and registry findings remain separately attributed below.", "findings": [ { "heading": "Investigational status remains separate from trial progress", "text": "FDA’s September 1, 2026 page states that retatrutide is not a component of an FDA-approved drug and cannot be used in compounding under federal law.", "citations": [ { "sourceId": "glp-unapproved", "locationId": "retatrutide" } ] }, { "heading": "TRIUMPH-1 is marked completed", "text": "The August 21 registry record for NCT05929066 reports 2,335 actual participants and April 30, 2026 completion. Its registered outcomes include weight change, sleep-apnea and knee-osteoarthritis subsets. The retrieved record has no posted summary results; completion alone is not an efficacy finding.", "citations": [ { "sourceId": "TRIUMPH-1", "locationId": "identity" }, { "sourceId": "TRIUMPH-1", "locationId": "status" }, { "sourceId": "TRIUMPH-1", "locationId": "design" } ] }, { "heading": "Cardiovascular and kidney outcomes are still being studied", "text": "NCT06383390 is active, not recruiting, in its August 24 record. It lists cardiovascular and kidney composite endpoints, estimated enrollment of 10,000, and estimated completion in February 2029. No summary results are posted in the retrieved record.", "citations": [ { "sourceId": "TRIUMPH-OUTCOMES", "locationId": "identity" }, { "sourceId": "TRIUMPH-OUTCOMES", "locationId": "status" }, { "sourceId": "TRIUMPH-OUTCOMES", "locationId": "design" } ] }, { "heading": "The obesity trial’s primary endpoint was at week 24", "text": "NCT04881760 enrolled 338 participants without diabetes. The registered primary endpoint is weight change at week 24, even though the treatment period lasted 48 weeks. The later weight result is a different time point.", "citations": [ { "sourceId": "nct04881760-20260919", "locationId": "design" }, { "sourceId": "nct04881760-20260919", "locationId": "eligibility" }, { "sourceId": "nct04881760-20260919", "locationId": "outcomes" }, { "sourceId": "nct04881760-20260919", "locationId": "flow" } ] }, { "heading": "The registry analysis excludes some post-discontinuation data", "text": "The primary obesity analysis uses participants with baseline and post-baseline measurements and excludes data after study-drug discontinuation. It therefore does not describe the outcome of assigning treatment regardless of whether everyone continued it.", "citations": [ { "sourceId": "nct04881760-20260919", "locationId": "results" } ] }, { "heading": "The diabetes trial has a different endpoint and comparator", "text": "NCT04867785 enrolled 281 participants with type 2 diabetes, with placebo and dulaglutide comparator groups. Its primary endpoint was 24-week HbA1c change; weight results should not replace that registered question.", "citations": [ { "sourceId": "nct04867785-20260919", "locationId": "design" }, { "sourceId": "nct04867785-20260919", "locationId": "results" } ] }, { "heading": "Rescue treatment changes the diabetes analysis population", "text": "The posted HbA1c analysis excludes data after permanent treatment discontinuation or initiation of rescue medication. This qualification belongs alongside effect estimates when comparing the registry with a paper or a different trial.", "citations": [ { "sourceId": "nct04867785-20260919", "locationId": "results" } ] } ], "remainingWork": [ "Reconcile phase 2 registry estimates with primary publications and preserve time points and estimands.", "Appraise newer phase 3 reports and follow cardiovascular/kidney outcomes; missing registry results do not imply no publication." ], "sources": [ { "id": "glp-unapproved", "title": "FDA concerns with unapproved GLP-1 drugs", "authority": "FDA", "kind": "web", "peptideSlugs": [ "semaglutide", "tirzepatide", "retatrutide" ], "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "retrievalUrl": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "sourceDate": "2026-09-01", "retrievedAt": "2026-09-16", "payloadSha256": "bfb6cd2a11e3f8e20bedfeed0e0d554205c76dd83f473956deb82afc186e51cc", "pageCount": null, "locations": [ { "id": "compounded", "label": "Concerns with compounded versions of these drugs", "pages": [] }, { "id": "salts", "label": "Salt forms should not be used to compound semaglutide", "pages": [] }, { "id": "reports", "label": "Adverse events related to compounded versions of semaglutide and tirzepatide", "pages": [] }, { "id": "retatrutide", "label": "Retatrutide and cagrilintide cannot be used in compounding", "pages": [] } ] }, { "id": "TRIUMPH-1", "title": "TRIUMPH-1 · NCT05929066", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "retatrutide" ], "url": "https://clinicaltrials.gov/study/NCT05929066", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT05929066", "sourceDate": "2026-08-21", "retrievedAt": "2026-09-16", "payloadSha256": "2a606fc27966954db54215572c5b8dce1fbe1d25910a88c0b4efebe1fda60795", "pageCount": null, "locations": [ { "id": "identity", "label": "protocolSection.identificationModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; 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This does not complete a registry search or replace primary-publication appraisal.", "findings": [ { "heading": "The obesity study measured weight at 46 weeks", "text": "NCT04667377 records 387 participants in a randomized placebo-controlled phase 2 study. The posted primary analysis reports adjusted mean weight changes from −6.19% to −14.94% across active groups versus −2.82% for placebo.", "citations": [ { "sourceId": "nct04667377-20260919", "locationId": "design" }, { "sourceId": "nct04667377-20260919", "locationId": "results" } ] }, { "heading": "The weight analysis handles discontinuations differently", "text": "The registry includes on- and off-treatment measurements for most participants, but uses only on-treatment values after COVID-related early discontinuation. Its estimate is therefore not directly comparable with every trial that excludes all post-discontinuation data.", "citations": [ { "sourceId": "nct04667377-20260919", "locationId": "results" } ] }, { "heading": "Histological improvement is not identical to disease resolution", "text": "NCT04771273 studied biopsy-confirmed steatohepatitis with F1–F3 fibrosis. Its primary definition requires a specified activity-score improvement without fibrosis worsening; it does not simply mean complete disease resolution or prevention of liver failure.", "citations": [ { "sourceId": "nct04771273-20260919", "locationId": "eligibility" }, { "sourceId": "nct04771273-20260919", "locationId": "outcomes" } ] }, { "heading": "Assigned and actual treatment analyses are separate", "text": "The liver-trial registry posts both planned-maintenance and actual-maintenance analyses, with different group denominators. Participants missing post-baseline biopsy data are classified as nonresponders. Selecting a favorable percentage without its analysis definition would be misleading.", "citations": [ { "sourceId": "nct04771273-20260919", "locationId": "results" } ] } ], "remainingWork": [ "Reconcile primary papers and analysis plans with assigned-treatment and actual-treatment registry results.", "Review phase 3 and longer-term liver and cardiovascular outcomes separately from phase 2 weight or biopsy endpoints." ], "sources": [ { "id": "nct04667377-20260919", "title": "A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "survodutide" ], "url": "https://clinicaltrials.gov/study/NCT04667377", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT04667377", "sourceDate": "2023-11-02", "retrievedAt": "2026-09-19", "payloadSha256": "588ec9f797b854a353ccd447452268099f4c25a84bc19c4e1552b680305d025f", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] } ] }, { "id": "nct04771273-20260919", "title": "A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "survodutide" ], "url": "https://clinicaltrials.gov/study/NCT04771273", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT04771273", "sourceDate": "2024-12-03", "retrievedAt": "2026-09-19", "payloadSha256": "9d26b4d6d050d31d899b83827781956db5d569fbdaf1f6dda9d6207d4bb5d8d9", "pageCount": null, "locations": [ { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] } ] } ], "versionPath": "/peptides/survodutide/source-notes/versions/1/" }, { "peptideSlug": "ghk-cu", "version": 2, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal. Earlier dated FDA and registry findings remain separately attributed below.", "findings": [ { "heading": "FDA’s records distinguish non-injectable GHK-Cu", "text": "The May 14, 2026 nominations list restores GHK-Cu excluding injectable routes to Category 1, meaning under evaluation. FDA explains that a nominator clarified its withdrawal applied only to the injectable route.", "citations": [ { "sourceId": "ghk-list", "locationId": "routes" } ] }, { "heading": "Injectable concerns remain separately documented", "text": "FDA’s safety page lists injectable GHK-Cu among withdrawn nominations, with concerns about aggregation, peptide impurities and immune responses, and limited human safety data. It should not be described as currently in Category 2 on that basis.", "citations": [ { "sourceId": "bulk-safety", "locationId": "injectable" } ] }, { "heading": "What the next review could clarify", "text": "The May list announces an intention to consult the advisory committee before the end of February 2027 about potential inclusion on the 503A bulks list. An announced consultation is not a completed review or a finding of effectiveness.", "citations": [ { "sourceId": "ghk-list", "locationId": "routes" } ] }, { "heading": "A registered topical wound study is now identifiable", "text": "NCT07437586 describes a phase 2 study of topical GHK-Cu gel in healthy adults. In the February 27, 2026 registry update it is recruiting, with estimated enrollment of 60 and no posted summary results.", "citations": [ { "sourceId": "nct07437586-20260919", "locationId": "design" }, { "sourceId": "nct07437586-20260919", "locationId": "status" } ] }, { "heading": "The comparison is within each participant", "text": "Each participant is to have two standardized wounds, one assigned to GHK-Cu gel and one to vehicle gel. This paired design means wound counts are not counts of independent people; it is not an injectable study.", "citations": [ { "sourceId": "nct07437586-20260919", "locationId": "design" } ] }, { "heading": "The primary endpoint is complete wound closure", "text": "The registered primary outcome is time to complete re-epithelialization, assessed through day 21 using blinded examination and photographs. The entry describes what investigators plan to measure, not an observed acceleration of healing.", "citations": [ { "sourceId": "nct07437586-20260919", "locationId": "outcomes" } ] }, { "heading": "The selected population excludes impaired-healing conditions", "text": "The trial excludes diabetes, peripheral vascular disease and other conditions that could impair wound healing. Even eventual positive results in this population would not automatically establish benefit in chronic ulcers or with injected GHK-Cu.", "citations": [ { "sourceId": "nct07437586-20260919", "locationId": "eligibility" }, { "sourceId": "nct07437586-20260919", "locationId": "design" } ] } ], "remainingWork": [ "Check later results and eligibility changes for NCT07437586; registration alone is not a clinical finding.", "Appraise topical human reports and FDA follow-up separately from injectable claims and product mixtures." ], "sources": [ { "id": "ghk-list", "title": "FDA 503A nominations list, May 14, 2026", "authority": "FDA", "kind": "pdf", "peptideSlugs": [ "ghk-cu" ], "url": "https://www.fda.gov/media/94155/download", "retrievalUrl": "https://www.fda.gov/media/94155/download", "sourceDate": "2026-05-14", "retrievedAt": "2026-09-16", "payloadSha256": "94f3353f1bdf65ac1800dfe747c5efdc33fa542f1ba40344a31e2fe286614415", "pageCount": 7, "locations": [ { "id": "routes", "label": "GHK-Cu correction and Category 1 entry", "pages": [ 1, 2, 3 ] } ] }, { "id": "bulk-safety", "title": "FDA bulk-substance safety concerns", "authority": "FDA", "kind": "web", "peptideSlugs": [ "ghk-cu" ], "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks", "retrievalUrl": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks", "sourceDate": "2026-04-22", "retrievedAt": "2026-09-16", "payloadSha256": "1a43f6d8b9da6b1fb5b2da83130882ec18e255f862c773d4cb636d67061c41cf", "pageCount": null, "locations": [ { "id": "injectable", "label": "Bulk drug substances nominated but withdrawn: GHK-Cu (for injectable routes of administration)", "pages": [] } ] }, { "id": "nct07437586-20260919", "title": "Topical GHK-Cu Gel for Acute Skin Wound Healing", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "ghk-cu" ], "url": "https://clinicaltrials.gov/study/NCT07437586", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT07437586", "sourceDate": "2026-02-27", "retrievedAt": "2026-09-19", "payloadSha256": "c57f70defe49f90fc8b52b29a993f517a64f5ba334ae0a74250855355a452421", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "outcomes", "label": "protocolSection.outcomesModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] } ], "versionPath": "/peptides/ghk-cu/source-notes/versions/2/" }, { "peptideSlug": "abaloparatide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.", "findings": [ { "heading": "ATOM’s primary result concerns bone density in men", "text": "NCT03512262 enrolled 228 men and measured lumbar-spine bone mineral density at 12 months. The posted modeled mean changes are 8.4820% with abaloparatide and 1.1654% with placebo; this endpoint is distinct from a direct fracture-reduction estimate.", "citations": [ { "sourceId": "nct03512262-20260919", "locationId": "design" }, { "sourceId": "nct03512262-20260919", "locationId": "results" } ] }, { "heading": "Randomized and analyzed counts differ", "text": "ATOM randomized 149 participants to abaloparatide and 79 to placebo, while its primary outcome table lists 119 and 66 evaluable participants. The total randomized sample should not be presented as the number with an observed 12-month measurement.", "citations": [ { "sourceId": "nct03512262-20260919", "locationId": "flow" }, { "sourceId": "nct03512262-20260919", "locationId": "results" } ] }, { "heading": "The extension studies sequential treatment", "text": "NCT01657162 enrolled eligible completers from the earlier abaloparatide-versus-placebo trial and then used alendronate in both groups. It evaluates treatment sequences; it is not a new randomized comparison of continued abaloparatide against placebo.", "citations": [ { "sourceId": "nct01657162-20260919", "locationId": "design" }, { "sourceId": "nct01657162-20260919", "locationId": "flow" }, { "sourceId": "nct01657162-20260919", "locationId": "results" } ] }, { "heading": "The fracture window starts before the extension", "text": "The extension’s primary vertebral-fracture endpoint runs from the parent trial’s baseline to extension month six. Its counts therefore should not be described as new fractures arising only during the extension, or compared with another trial without matching the time window.", "citations": [ { "sourceId": "nct01657162-20260919", "locationId": "results" } ] } ], "remainingWork": [ "Reconcile ATOM missing-data methods and fracture outcomes with the primary report and regulatory supplement.", "Appraise sequential-treatment follow-up without counting parent and extension participants twice." ], "sources": [ { "id": "nct01657162-20260919", "title": "Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "abaloparatide" ], "url": "https://clinicaltrials.gov/study/NCT01657162", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT01657162", "sourceDate": "2020-12-11", "retrievedAt": "2026-09-19", "payloadSha256": "b9968ba5bde74d8fb94ad28094be33dc0895fa2ef32e0ae543e8be75157428b2", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "flow", "label": "resultsSection.participantFlowModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] } ] }, { "id": "nct03512262-20260919", "title": "Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "abaloparatide" ], "url": "https://clinicaltrials.gov/study/NCT03512262", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT03512262", "sourceDate": "2023-04-07", "retrievedAt": "2026-09-19", "payloadSha256": "87a3c49f62227506d0aaaa3aa5544e79ab386e54ce534b7d0756d4c497e865c3", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "flow", "label": "resultsSection.participantFlowModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] } ] } ], "versionPath": "/peptides/abaloparatide/source-notes/versions/1/" }, { "peptideSlug": "afamelanotide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.", "findings": [ { "heading": "The variegate-porphyria study was very small and uncontrolled", "text": "NCT05854784 records six participants in an open-label, single-group phase 2 study. This is a different condition and design from the randomized erythropoietic-protoporphyria program.", "citations": [ { "sourceId": "nct05854784-20260919", "locationId": "design" }, { "sourceId": "nct05854784-20260919", "locationId": "eligibility" } ] }, { "heading": "An observed rating change is not a controlled treatment effect", "text": "The variegate-porphyria record reports a median clinical global-impression change score of 2.5 at day 168 among six participants. Without a control group and blinded assessment, this finding alone cannot establish how much change afamelanotide caused.", "citations": [ { "sourceId": "nct05854784-20260919", "locationId": "design" }, { "sourceId": "nct05854784-20260919", "locationId": "results" } ] }, { "heading": "The newer EPP record focuses on pharmacokinetics", "text": "NCT06388642 records 28 participants with erythropoietic protoporphyria in a completed single-group study. Its primary outcomes measure peak plasma concentration and exposure over seven days, rather than a randomized comparison of clinical efficacy.", "citations": [ { "sourceId": "nct06388642-20260919", "locationId": "design" }, { "sourceId": "nct06388642-20260919", "locationId": "results" } ] }, { "heading": "Age eligibility is not proof of an age-specific result", "text": "The pharmacokinetic study permits ages 12–70 but posts aggregate results for 28 participants. Those aggregate values do not establish a separate adolescent efficacy effect or show that every eligible age was represented.", "citations": [ { "sourceId": "nct06388642-20260919", "locationId": "eligibility" }, { "sourceId": "nct06388642-20260919", "locationId": "results" } ] } ], "remainingWork": [ "Appraise the six-person variegate-porphyria report and reconcile outcome definitions and safety details.", "Review age-specific pharmacokinetic data and later EPP evidence without inferring pediatric efficacy from eligibility alone." ], "sources": [ { "id": "nct05854784-20260919", "title": "Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "afamelanotide" ], "url": "https://clinicaltrials.gov/study/NCT05854784", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT05854784", "sourceDate": "2025-04-27", "retrievedAt": "2026-09-19", "payloadSha256": "5b7d65ab39da370ec4a017425e4c2cc62ae6c0fc48b0c5d2e636da0523ff6099", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] } ] }, { "id": "nct06388642-20260919", "title": "Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "afamelanotide" ], "url": "https://clinicaltrials.gov/study/NCT06388642", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT06388642", "sourceDate": "2026-07-27", "retrievedAt": "2026-09-19", "payloadSha256": "3ef889a13159fc222504d3f99265fdd145895cb9d7771e24dd51691165c52ffe", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] } ] } ], "versionPath": "/peptides/afamelanotide/source-notes/versions/1/" }, { "peptideSlug": "vosoritide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "scope": "Selected sponsor-submitted ClinicalTrials.gov records retrieved September 19, 2026, with design, population, endpoint and result-availability checks. This does not complete a registry search or replace primary-publication appraisal.", "findings": [ { "heading": "Seventy-five enrolled does not mean seventy-five randomized", "text": "NCT03583697 enrolled 75 children younger than five: 11 sentinel participants received vosoritide and 64 were randomized equally to vosoritide or placebo. The sentinel and randomized groups serve different purposes.", "citations": [ { "sourceId": "nct03583697-20260919", "locationId": "eligibility" }, { "sourceId": "nct03583697-20260919", "locationId": "flow" } ] }, { "heading": "The growth endpoint requires its analysis population", "text": "The primary efficacy outcome was change in height Z-score at week 52. The registry separately reports the randomized comparison and an analysis adding the sentinel group; their modeled estimates should not be merged.", "citations": [ { "sourceId": "nct03583697-20260919", "locationId": "results" } ] }, { "heading": "Safety observations are not all treatment-caused events", "text": "The posted table reports adverse events in every group and one death in the randomized vosoritide group. The participant-flow account labels that sudden-infant-death event unrelated, and the safety table reports no treatment-related serious events. These small samples cannot establish a precise rare-event risk.", "citations": [ { "sourceId": "nct03583697-20260919", "locationId": "flow" }, { "sourceId": "nct03583697-20260919", "locationId": "results" } ] }, { "heading": "The extension is open-label follow-up", "text": "NCT03989947 follows 73 participants who completed the earlier study, using a single-group open-label design. Its March 13, 2026 record is active, not recruiting, without posted summary results; it is not an additional independent placebo-controlled trial.", "citations": [ { "sourceId": "nct03989947-20260919", "locationId": "design" }, { "sourceId": "nct03989947-20260919", "locationId": "eligibility" }, { "sourceId": "nct03989947-20260919", "locationId": "status" } ] } ], "remainingWork": [ "Reconcile the young-child publication and regulatory extension with sentinel and randomized populations.", "Review longer-term developmental, functional and safety follow-up separately from growth endpoints." ], "sources": [ { "id": "nct03583697-20260919", "title": "A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "vosoritide" ], "url": "https://clinicaltrials.gov/study/NCT03583697", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT03583697", "sourceDate": "2024-06-13", "retrievedAt": "2026-09-19", "payloadSha256": "67e90e6eeb1b0d458b42edcb6e30ca37b0c76a6d08db5a1ce96226678acda430", "pageCount": null, "locations": [ { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "flow", "label": "resultsSection.participantFlowModule", "pages": [] }, { "id": "results", "label": "resultsSection.outcomeMeasuresModule", "pages": [] } ] }, { "id": "nct03989947-20260919", "title": "An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia", "authority": "ClinicalTrials.gov", "kind": "registry", "peptideSlugs": [ "vosoritide" ], "url": "https://clinicaltrials.gov/study/NCT03989947", "retrievalUrl": "https://clinicaltrials.gov/api/v2/studies/NCT03989947", "sourceDate": "2026-03-13", "retrievedAt": "2026-09-19", "payloadSha256": "9f16f6b15187f3aaf6ef47241d4be33ab90022159089572c18758a667866b299", "pageCount": null, "locations": [ { "id": "design", "label": "protocolSection.identificationModule, designModule and armsInterventionsModule", "pages": [] }, { "id": "eligibility", "label": "protocolSection.eligibilityModule and armsInterventionsModule", "pages": [] }, { "id": "status", "label": "protocolSection.statusModule; presence or absence of resultsSection in retrieved record", "pages": [] } ] } ], "versionPath": "/peptides/vosoritide/source-notes/versions/1/" } ] }