Retatrutide official-source update · version 1
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Official-source update
Reviewed 2026-09-16 · Preserved version 1
Investigational status remains separate from trial progress
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. FDA source ↗
More findings and the sources behind them
A dated FDA statement and two sponsor-submitted ClinicalTrials.gov records; registry status and planned endpoints are distinct from reported trial outcomes.
TRIUMPH-1 is marked completed
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. NCT05929066 ↗
Cardiovascular and kidney outcomes are still being studied
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. NCT06383390 ↗
What remains to be checked
- 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.
Source dates and review coverage
PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.
FDA concerns with unapproved GLP-1 drugs ↗
Source dated 2026-09-01; retrieved 2026-09-16.
- Concerns with compounded versions of these drugs
- Salt forms should not be used to compound semaglutide
- Adverse events related to compounded versions of semaglutide and tirzepatide
- Retatrutide and cagrilintide cannot be used in compounding
SHA-256:
bfb6cd2a11e3f8e20bedfeed0e0d554205c76dd83f473956deb82afc186e51ccTRIUMPH-1 · NCT05929066 ↗
Source dated 2026-08-21; retrieved 2026-09-16.
- protocolSection.identificationModule
- protocolSection.statusModule; hasResults
- protocolSection.designModule; protocolSection.outcomesModule.primaryOutcomes
SHA-256:
2a606fc27966954db54215572c5b8dce1fbe1d25910a88c0b4efebe1fda60795TRIUMPH-OUTCOMES · NCT06383390 ↗
Source dated 2026-08-24; retrieved 2026-09-16.
- protocolSection.identificationModule
- protocolSection.statusModule; hasResults
- protocolSection.designModule; protocolSection.outcomesModule.primaryOutcomes
SHA-256:
92fbfee77c8e9b0797c4cf847951faee64e617d3b1e940f2123711936eba886b