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Retatrutide official-source update · version 2

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Official-source update

Reviewed 2026-09-19 · Preserved version 2

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

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.

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 ↗

The obesity trial’s primary endpoint was at week 24

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. NCT04881760 ↗

The registry analysis excludes some post-discontinuation data

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. NCT04881760 ↗

The diabetes trial has a different endpoint and comparator

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. NCT04867785 ↗

Rescue treatment changes the diabetes analysis population

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. NCT04867785 ↗

What remains to be checked

  • 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.
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: bfb6cd2a11e3f8e20bedfeed0e0d554205c76dd83f473956deb82afc186e51cc

  • TRIUMPH-1 · NCT05929066 ↗

    Source dated 2026-08-21; retrieved 2026-09-16.

    • protocolSection.identificationModule
    • protocolSection.statusModule; hasResults
    • protocolSection.designModule; protocolSection.outcomesModule.primaryOutcomes

    SHA-256: 2a606fc27966954db54215572c5b8dce1fbe1d25910a88c0b4efebe1fda60795

  • TRIUMPH-OUTCOMES · NCT06383390 ↗

    Source dated 2026-08-24; retrieved 2026-09-16.

    • protocolSection.identificationModule
    • protocolSection.statusModule; hasResults
    • protocolSection.designModule; protocolSection.outcomesModule.primaryOutcomes

    SHA-256: 92fbfee77c8e9b0797c4cf847951faee64e617d3b1e940f2123711936eba886b

  • A Study of LY3437943 in Participants With Type 2 Diabetes ↗

    Source dated 2023-07-03; retrieved 2026-09-19.

    • protocolSection.identificationModule, designModule and armsInterventionsModule
    • resultsSection.outcomeMeasuresModule

    SHA-256: d982d0da7ad7e0331422e07f197da1d47a7ed1febaa74be7d807bc6a8512ee2b

  • A Study of LY3437943 in Participants Who Have Obesity or Are Overweight ↗

    Source dated 2023-09-13; retrieved 2026-09-19.

    • protocolSection.identificationModule, designModule and armsInterventionsModule
    • protocolSection.eligibilityModule and armsInterventionsModule
    • resultsSection.participantFlowModule
    • protocolSection.outcomesModule
    • resultsSection.outcomeMeasuresModule

    SHA-256: 02ff67711c363c67a5a141a183cc3f734d4702e1b3877385214a39abc81b20b4

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