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TRIUMPH Phase 3 Clinical Trials
Phase 2 and Phase 3 trial results from Eli Lilly's clinical program evaluating Retatrutide (LY3437943) in obesity, Type 2 Diabetes, cardiovascular disease, osteoarthritis, and MASH/MASLD.
Obesity without T2D
Adults with BMI ≥ 30 (or ≥ 27 with comorbidity), without Type 2 Diabetes. 80-week treatment with 12 mg maintenance dose.
- 12 mg dose: Mean weight reduction of -28.3%.
- 9 mg dose: Weight loss of -25.9%.
- 4 mg dose: Weight loss of -19.0%.
- Placebo: -2.2%. Discontinuation due to adverse events: 11.3% on 12 mg vs 4.9% on placebo.
- 45.3% of patients on 12 mg achieved ≥ 30% weight loss.
- Extension study (104 weeks, BMI ≥ 35, n = 532): -30.3% weight loss (85.0 lbs, ≈ 38.6 kg).
Obesity + Type 2 Diabetes
Patients with Type 2 Diabetes and obesity. 80-week treatment evaluating glycemic control and weight loss.
- Mean weight reduction of -20.8% at 12 mg dose.
- HbA1c reduction of -1.5%.
- Weight: -12.7% (4 mg), -19.1% (9 mg), -20.8% (12 mg) vs -4.0% on placebo. Up to 40.0% reached HbA1c < 5.7%.
- Full results presented at EASD (Milan) and published in The Lancet, 29 Sept 2026.
Obesity + Cardiovascular Disease
Patients with obesity and established cardiovascular disease. 80-week treatment with 12 mg dose.
- Mean weight reduction of -22.6% at 12 mg dose.
- 9 mg: -21.6%; placebo: -3.2%. Discontinuation due to adverse events: 9.8% (9 mg), 13.5% (12 mg) vs 4.8% on placebo.
- The trial was not powered to assess cardiovascular events; cardiovascular outcomes are being studied separately.
Obesity + Knee Osteoarthritis
Patients with obesity and knee osteoarthritis. 68-week treatment evaluating weight loss and joint pain reduction.
- Mean weight reduction of -28.7% at 12 mg dose.
- WOMAC knee pain: -75.8% (9 mg) / -74.3% (12 mg) vs -40.3% on placebo (post-hoc %).
- Significant improvement in mobility and quality of life.
Type 2 Diabetes (diet and exercise alone)
- HbA1c (baseline 7.9%, 40 weeks): -1.7% / -2.0% / -1.9% (4 / 9 / 12 mg) vs -0.8% on placebo.
- Weight: -11.5% / -15.5% / -16.8% vs -2.5% on placebo; no plateau observed.
Safety: adverse events on 12 mg vs placebo (Phase 3)
| Event | TRIUMPH-1 | TRIUMPH-2 | TRIUMPH-3 | TRANSCEND-T2D-1 |
|---|---|---|---|---|
| Nausea | 42.4% / 14.8% | 28.0% / 8.0% | 22.4% / 5.8% | 26.5% / 3.7% |
| Diarrhea | 32.0% / 13.5% | 33.6% / 13.2% | 24.4% / 8.7% | 22.8% / 4.5% |
| Vomiting | 25.3% / 4.8% | 15.7% / 4.2% | — | 17.6% / 2.2% |
| Dysesthesia | 12.5% / 0.9% | 7.3% / 0.7% | 6.4% / 1.3% | 4.4% / 0% |
| Stopped due to AEs | 11.3% / 4.9% | 7.7% / 4.9% | 13.5% / 4.8% | 5.1% / 0% |
Format: retatrutide 12 mg / placebo. Source: Eli Lilly press releases. Gastrointestinal events occurred mainly during dose escalation and were mostly mild to moderate.
Up to -86% Liver Fat Reduction at 24 Weeks
Glucagon receptor activation directly stimulates hepatic fatty acid oxidation. In the Phase 2 trial, 80%+ of participants receiving 8 mg or 12 mg Retatrutide achieved complete resolution of fatty liver (liver fat < 5%).
Summary Table of Published Clinical Data
| Trial / Study | Population / Indication | Duration | Dose | Weight Loss (%) | HbA1c Drop | N | Source |
|---|---|---|---|---|---|---|---|
| TRIUMPH-1 (Phase 3, topline) | Obesity without T2D (BMI ≥ 30 or ≥ 27 with comorbidity) | 80 wk | 12 mg | -28.3% | N/A | 2 339 | Source |
| TRIUMPH-1 (Phase 3, 9 mg dose) | Obesity without T2D | 80 wk | 9 mg | -25.9% | N/A | 2 339 | Source |
| TRIUMPH-1 (Phase 3, 4 mg dose) | Obesity without T2D | 80 wk | 4 mg | -19% | N/A | 2 339 | Source |
| TRIUMPH-1 (Phase 3, extension) | Obesity, BMI ≥ 35 (extension study, 104 wk) | 104 wk | 12 mg | -30.3% | N/A | 532 | Source |
| TRIUMPH-2 (Phase 3) | Obesity + Type 2 Diabetes | 80 wk | 12 mg | -20.8% | -1.5% | 1 152 | Source |
| TRIUMPH-3 (Phase 3) | Obesity + Cardiovascular Disease | 80 wk | 12 mg | -22.6% | N/A | 1 949 | Source |
| TRIUMPH-4 (Phase 3) | Obesity + Knee Osteoarthritis | 68 wk | 12 mg | -28.7% | N/A | 445 | Source |
| TRANSCEND-T2D-1 (Phase 3) | Type 2 Diabetes | 40 wk | 12 mg | -16.8% | -1.9% | 537 | Source |
| Phase 2 Jastreboff et al. (NEJM) | Obesity (BMI 35–45) | 48 wk | 12 mg | -24.2% | N/A | 338 | Source |
| Phase 2 MASH Substudy | Steatohepatitis / Fatty Liver Disease (MASH/MASLD) | 24 wk | 12 mg | -20% | N/A | 98 | Source |