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Retatrutide: Trials and FDA Status

Retatrutide is a glp-1/gip/glucagon triple agonist. This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.

Also calledLY3437943GLP-3
Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated

Where it stands

US status
Investigational · phase 3 (TRIUMPH)
Phase
Phase 3
Sponsor
Eli Lilly
Expected FDA decision
Sponsor statement
Lilly states it plans to submit a Biologics License Application to the U.S. FDA in the first quarter of 2027 (a submission plan, not an FDA decision date).
Trial IDs (NCT)
NCT04881760, NCT04867785, NCT05929066, NCT05929079, NCT05882045, NCT05931367
Results

Reported results

  • 2026TRIUMPH-1 phase 3 (NEJM 2026): mean weight change at 80 weeks vs placebo“The mean percent change in body weight in the retatrutide groups was -17.6% (4-mg dose), -23.7% (9-mg dose), and -25.0% (12-mg dose) versus -3.9% in the placebo group”pubmed.ncbi.nlm.nih.gov
  • 2023Phase 2 (NEJM 2023): weight change at 48 weeks“At 48 weeks, the least-squares mean percentage change in the retatrutide groups was -8.7% in the 1-mg group, -17.1% in the combined 4-mg group, -22.8% in the combined 8-mg group, and -24.2% in the 12-mg group, as compared with -2.1% in the placebo group.”pubmed.ncbi.nlm.nih.gov
  • Weight change, 12 mg at 80 weeks (TRIUMPH-1 phase 3, NEJM 2026; treatment-regimen estimand)[2]−25.0%
  • Weight change, 9 mg at 80 weeks (TRIUMPH-1)[2]−23.7%
  • Weight change, 4 mg at 80 weeks (TRIUMPH-1)[2]−17.6%
  • Weight change, placebo at 80 weeks (TRIUMPH-1)[2]−3.9%
  • Weight change, 12 mg at 80 weeks (TRIUMPH-1 efficacy estimand, company-reported)[1]−28.3%
  • Weight change, 12 mg at 48 weeks (phase 2, NEJM 2023; placebo −2.1%)[3]−24.2%

Company-reported figures are labelled as such. Results in a trial population may not match results elsewhere.

Timeline

Milestones

Expected decision: Lilly states it plans to submit a Biologics License Application to the U.S. FDA in the first quarter of 2027 (a submission plan, not an FDA decision date). Eli Lilly (press release)

  1. Retatrutide phase 3 TRIUMPH-1 results publishedTrial
  2. FDA warning letters to five research-peptide sellersEnforcement
  3. Eli Lilly sues six retatrutide sellersOther
  4. Lilly reports positive data from three additional Phase 3 retatrutide obesity trials and a complete clinical package
  5. NCT05929079 (TRIUMPH-2; Phase 3): primary completion
  6. NCT05882045 (TRIUMPH-3; Phase 3): primary completion
  7. NCT05929066 (TRIUMPH-1; Phase 3): primary completion
  8. Seven FDA warning letters to online sellers of GLP-1 productsEnforcement
  9. Published in The New England journal of medicine (2026): Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity.
  10. Published in Lancet (London, England) (2026): Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial.
  11. NCT05931367 (TRIUMPH-4; Phase 3): primary completion
  12. NCT05931367 (TRIUMPH-4; Phase 3): study start
  13. NCT05929079 (TRIUMPH-2; Phase 3): study start
  14. NCT05929066 (TRIUMPH-1; Phase 3): study start
  15. NCT05931367 (TRIUMPH-4; Phase 3): first posted on ClinicalTrials.gov
  16. NCT05929066 (TRIUMPH-1; Phase 3): first posted on ClinicalTrials.gov
  17. NCT05929079 (TRIUMPH-2; Phase 3): first posted on ClinicalTrials.gov
  18. NCT05882045 (TRIUMPH-3; Phase 3): first posted on ClinicalTrials.gov
  19. NCT05882045 (TRIUMPH-3; Phase 3): study start
  20. Published in The New England journal of medicine (2023): Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial.
  21. NCT04867785 (A Study of LY3437943 in Participants With Type 2 Diabetes; Phase 2): primary completion
  22. NCT04881760 (A Study of LY3437943 in Participants Who Have Obesity or Are Overweight; Phase 2): primary completion
  23. NCT04881760 (A Study of LY3437943 in Participants Who Have Obesity or Are Overweight; Phase 2): study start
  24. NCT04867785 (A Study of LY3437943 in Participants With Type 2 Diabetes; Phase 2): study start
  25. NCT04881760 (A Study of LY3437943 in Participants Who Have Obesity or Are Overweight; Phase 2): first posted on ClinicalTrials.gov
  26. NCT04867785 (A Study of LY3437943 in Participants With Type 2 Diabetes; Phase 2): first posted on ClinicalTrials.gov

What people search

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US monthly searches, Google Keyword Planner, Oct 2026. Shown so you can see which questions this page answers.

Sources

  1. 1Lilly's triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trial (21 May 2026)Eli Lilly and Company (press release) · 2026investor.lilly.comAccessed 2 Oct 2026
  2. 2Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity (TRIUMPH-1; Jastreboff AM et al.)New England Journal of Medicine · 2026PMID 42814954Accessed 2 Oct 2026
  3. 3Triple-Hormone-Receptor Agonist Retatrutide for Obesity: A Phase 2 Trial (Jastreboff AM et al.)New England Journal of Medicine · 2023PMID 37366315Accessed 2 Oct 2026
  4. 4A Study of LY3437943 in Participants Who Have Obesity or Are Overweight (NCT04881760)ClinicalTrials.gov (U.S. National Library of Medicine) · 2021clinicaltrials.govAccessed 2 Oct 2026
  5. 5A Study of LY3437943 in Participants With Type 2 Diabetes (NCT04867785)ClinicalTrials.gov (U.S. National Library of Medicine) · 2021clinicaltrials.govAccessed 2 Oct 2026
  6. 6TRIUMPH-1: A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight (NCT05929066)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  7. 7TRIUMPH-2: A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight (NCT05929079)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  8. 8TRIUMPH-3: A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease (NCT05882045)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  9. 9TRIUMPH-4: A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee (NCT05931367)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  10. 10Retatrutide phase 3 TRIUMPH-1 results publishedNEJM (PubMed 42814954) · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
  11. 11FDA warning letters to five research-peptide sellersFDA warning letter (NuScience Peptides; 1 of 5) · 2026fda.govAccessed 2 Oct 2026
  12. 12Eli Lilly sues six retatrutide sellersEli Lilly (press release) · 2026investor.lilly.comAccessed 2 Oct 2026
  13. 13Seven FDA warning letters to online sellers of GLP-1 productsFDA warning letter (Gram Peptides; 1 of 7) · 2026fda.govAccessed 2 Oct 2026
  14. 14Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial.Lancet (London, England) · 2026PMID 42810372Accessed 2 Oct 2026
  15. 15Lilly reports positive data from three additional Phase 3 retatrutide obesity trials and a complete clinical packageEli Lilly (press release) · 2026sec.govAccessed 2 Oct 2026

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