Key Phase 2 Clinical Trial Results
The Phase 2 dose-ranging trial evaluated retatrutide doses from 0.5mg to 12mg administered once weekly for 48 weeks, demonstrating dose-dependent weight loss:
| Dose | Mean Weight Loss (48 weeks) | ≥5% Responders | ≥15% Responders |
|---|---|---|---|
| Placebo | −2.1% | 27% | 3% |
| 4mg weekly | −17.5% | 89% | 60% |
| 8mg weekly | −22.8% | 92% | 71% |
| 12mg weekly | −24.2% | 91% | 75% |
The 12mg dose achieved 24.2% mean body weight reduction at 48 weeks — the highest observed in any metabolic research trial to date, with 75% of participants achieving ≥15% weight loss, comparable to bariatric surgery outcomes.
Secondary Metabolic Endpoints
- Glycemic control: HbA1c reduction of 1.9% in participants with baseline dysglycemia
- Triglycerides: 32% reduction from baseline
- LDL cholesterol: 28% reduction
- HDL cholesterol: 15% increase
- Systolic blood pressure: 10–15 mmHg reduction
- Liver fat: 67% relative reduction (MRI-PDFF)
- Insulin sensitivity: 2.5-fold improvement in HOMA-IR
Retatrutide vs Semaglutide vs Tirzepatide
| Compound | Mechanism | Mean Weight Loss | Trial Duration |
|---|---|---|---|
| Semaglutide 2.4mg | GLP-1 agonist | 14.9% | 68 weeks |
| Tirzepatide 15mg | GLP-1/GIP dual | 20.9% | 72 weeks |
| Retatrutide 12mg | GLP-1/GIP/Glucagon triple | 24.2% | 48 weeks |
Retatrutide achieved 62% greater weight loss than semaglutide and 16% greater than tirzepatide — in a shorter 48-week timeframe.
Phase 3 Clinical Trial Program (Ongoing 2026)
- TRIUMPH-1: Retatrutide vs placebo, elevated BMI (n=2,400, 72 weeks)
- TRIUMPH-2: Retatrutide vs placebo, Type 2 diabetes (n=1,800, 52 weeks)
- TRIUMPH-3: Head-to-head vs semaglutide 2.4mg (n=1,200, 72 weeks)
- TRIUMPH-4: Cardiovascular outcomes trial (n=12,000, 5-year)
Results from TRIUMPH-1 expected Q4 2026. If successful, regulatory submissions to FDA and EMA in 2027, with potential approval 2028–2029.
Safety Profile
Adverse events are consistent with the incretin class:
- Nausea: 60–70% of participants (mostly mild, resolves during maintenance)
- Diarrhea: 40–50%
- Vomiting: 30–40%
- Discontinuation due to adverse events: 10.5% (comparable to other incretin therapies)
- No significant pancreatitis, gallbladder, or cardiovascular safety signals
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