The TRIUMPH program is Eli Lilly's Phase 3 clinical trial program for retatrutide (LY3437943). Six trials are currently active, recruiting, or completed across obesity, type 2 diabetes, cardiovascular disease, liver disease, and chronic kidney disease.
8
Phase 3 trials
7
Active / recruiting
19,078
Total enrollment
4
Completed
Phase 3Active28.3% weight loss
TRIUMPH-1: Retatrutide in Adults with Obesity or Overweight
NCT05929066 · Eli Lilly
Population
Adults with obesity (BMI ≥ 30) or overweight (BMI ≥ 27) with ≥ 1 weight-related comorbidity, without type 2 diabetes; includes subsets with osteoarthritis and obstructive sleep apnea
Primary endpoint
Percent change in body weight from baseline at 80 weeks
In Lilly's topline Phase 3 results, mean body-weight reductions at 80 weeks were: 19.0% with retatrutide 4 mg; 25.9% with retatrutide 9 mg; 28.3% with retatrutide 12 mg. These results are Phase 3 topline findings reported by Eli Lilly and should not be confused with the earlier 48-week Phase 2 obesity trial. Retatrutide remains investigational and is not FDA approved. Lilly has stated that it plans to submit retatrutide for regulatory review in Q1 2027. Sources: Eli Lilly and Company; ClinicalTrials.gov NCT05929066.
Phase 2: Retatrutide Dose-Finding in Obesity (Completed)
NCT04881760 · Eli Lilly
Population
Adults with obesity (BMI 30–50 kg/m²) without diabetes, n=338
Primary endpoint
Percent change in body weight from baseline at 24 weeks
Enrollment
338 participants
Est. completion
Completed 2023
Key result
At 48 weeks, mean weight loss was 17.5% (4 mg), 17.3% (8 mg), and 24.2% (12 mg) vs. 2.1% placebo. All doses statistically significant (p<0.001). Published in NEJM, June 2023.
Phase 2: Retatrutide Dose-Finding in Type 2 Diabetes (Completed)
NCT04881773 · Eli Lilly
Population
Adults with type 2 diabetes (HbA1c 7–10.5%), BMI 23–50 kg/m², n=281
Primary endpoint
Change in HbA1c from baseline at 26 weeks
Enrollment
281 participants
Est. completion
Completed 2023
Key result
At 26 weeks: HbA1c reductions of −2.02% (4 mg), −2.31% (8 mg), −2.31% (12 mg) vs. −0.44% placebo. Mean body weight reductions: −8.7% (4 mg), −12.9% (8 mg), −16.9% (12 mg) vs. −2.1% placebo. All doses statistically significant. Published in NEJM, June 2023 (companion paper to obesity Phase 2).
Phase 2: Retatrutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH)
NCT05019261 · Eli Lilly
Population
Adults with biopsy-confirmed MASH (NASH) and fibrosis stage F1–F3, with or without type 2 diabetes, n=~200
Primary endpoint
Change in liver fat content by MRI-PDFF from baseline at 24 weeks
Enrollment
200 participants
Est. completion
Completed 2024
Key result
Retatrutide produced significant reductions in liver fat by MRI-PDFF and improvements in liver enzymes (ALT, AST) at 24 weeks. Histological data from the biopsy subset showed MASH resolution rates consistent with the drug's weight loss and glucagon receptor-mediated hepatic effects. Full results pending peer-reviewed publication; data informed the TRIUMPH-MASH Phase 3 design.
