TRIUMPH-Outcomes: Cardiovascular Outcomes Trial for Retatrutide
NCT06051721 · Eli Lilly
- Phase
- Phase 3
- Enrollment
- 9,000 participants
- Est. completion
- Q4 2028
- Sponsor
- Eli Lilly
Background
TRIUMPH-CVOT is a Phase 3, event-driven cardiovascular outcomes trial required by the FDA for obesity/diabetes drugs. It evaluates whether retatrutide reduces the risk of major adverse cardiovascular events (MACE) in high-risk patients. This is the largest and longest TRIUMPH trial, with a minimum follow-up of 3 years.
Primary endpoint
Time to first occurrence of MACE: CV death, non-fatal MI, or non-fatal stroke
Secondary endpoints
- All-cause mortality
- Hospitalization for heart failure
- Coronary revascularization
- Change in body weight
- Change in HbA1c (in participants with T2D)
Population
Adults with established cardiovascular disease and obesity or overweight, with or without type 2 diabetes
Intervention
Retatrutide 12 mg SC once weekly (or maximum tolerated dose) vs. placebo; dose escalation over 24 weeks
Inclusion criteria
Adults ≥ 45 years; established CVD (prior MI, stroke, or peripheral arterial disease); BMI ≥ 27 kg/m²; with or without type 2 diabetes
Exclusion criteria
Recent ACS or stroke (< 60 days); NYHA Class IV heart failure; eGFR < 20 mL/min/1.73m²; personal or family history of medullary thyroid carcinoma or MEN2
Trial information sourced from ClinicalTrials.gov and published literature. TryTrutide is not affiliated with Eli Lilly or any trial site. This is not medical advice.