TRIUMPH-3: Retatrutide in Adults with Cardiovascular Disease and Severe Obesity
NCT05882045 · Eli Lilly
- Phase
- Phase 3
- Enrollment
- 2,100 participants
- Est. completion
- Q2 2027
- Sponsor
- Eli Lilly
Background
TRIUMPH-3 is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating retatrutide in adults with established cardiovascular disease and severe obesity. It is designed to assess both weight loss and cardiovascular outcomes in a high-risk population. Topline results were announced by Eli Lilly on July 23, 2026.
Key result
Topline results announced July 23, 2026. Up to 22.6% mean body weight reduction. Peer-reviewed publication pending.
Primary endpoint
Percent change in body weight from baseline at 80 weeks
Secondary endpoints
- Proportion achieving ≥ 5% body weight reduction
- Proportion achieving ≥ 10% body weight reduction
- Proportion achieving ≥ 15% body weight reduction
- Change in waist circumference
- Change in systolic blood pressure
- Change in fasting lipids
Population
Adults with established cardiovascular disease and severe obesity (BMI ≥ 35 kg/m²)
Intervention
Retatrutide 4 mg, 8 mg, or 12 mg SC once weekly vs. placebo; dose escalation over 24 weeks with lifestyle counseling
Inclusion criteria
Adults ≥ 18 years; BMI ≥ 30 kg/m², or BMI ≥ 27 kg/m² with ≥ 1 weight-related comorbidity (hypertension, dyslipidemia, OSA, or cardiovascular disease); no type 2 diabetes diagnosis
Exclusion criteria
Type 2 diabetes; prior bariatric surgery; use of weight-loss medications in prior 3 months; personal or family history of medullary thyroid carcinoma or MEN2; recent cardiovascular event (< 6 months)
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.