Phase 2: Retatrutide Dose-Finding in Obesity (Completed)
NCT04881760 · Eli Lilly
- Phase
- Phase 2
- Enrollment
- 338 participants
- Est. completion
- Completed 2023
- Sponsor
- Eli Lilly
Background
The pivotal Phase 2 dose-finding trial that established retatrutide's efficacy profile in obesity. Published in the New England Journal of Medicine (Jastreboff et al., 2023). The 24.2% mean weight loss at 48 weeks with 12 mg dosing was the highest reported for any pharmacological agent at the time of publication.
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.
Primary endpoint
Percent change in body weight from baseline at 24 weeks
Secondary endpoints
- Percent change in body weight at 48 weeks
- Proportion achieving ≥ 5%, ≥ 10%, ≥ 15%, ≥ 20% weight loss
- Change in waist circumference
- Change in cardiometabolic risk factors
Population
Adults with obesity (BMI 30–50 kg/m²) without diabetes, n=338
Intervention
Retatrutide 1 mg, 4 mg, 8 mg, or 12 mg SC once weekly vs. placebo; dose escalation over 24 weeks
Inclusion criteria
Adults ≥ 18 years; BMI 30–50 kg/m²; no type 2 diabetes; stable weight (< 5 kg change in prior 3 months)
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
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.