Phase 2: Retatrutide Dose-Finding in Type 2 Diabetes (Completed)
NCT04881773 · Eli Lilly
- Phase
- Phase 2
- Enrollment
- 281 participants
- Est. completion
- Completed 2023
- Sponsor
- Eli Lilly
Background
The Phase 2 dose-finding trial in type 2 diabetes, published alongside the obesity Phase 2 trial in the New England Journal of Medicine (Jastreboff et al., 2023). The trial demonstrated substantial HbA1c reductions and weight loss across all doses, with the 12 mg dose producing 16.9% mean body weight reduction at 26 weeks — substantially exceeding semaglutide and tirzepatide Phase 2 T2D results at comparable timepoints.
Key result
At 26 weeks: HbA1c reductions of −2.02% (4 mg), −2.31% (8 mg), −2.31% (12 mg) vs. −0.44% placebo. Mean body weight reductions: −8.7% (4 mg), −12.9% (8 mg), −16.9% (12 mg) vs. −2.1% placebo. All doses statistically significant. Published in NEJM, June 2023 (companion paper to obesity Phase 2).
Primary endpoint
Change in HbA1c from baseline at 26 weeks
Secondary endpoints
- Percent change in body weight from baseline at 26 weeks
- Proportion achieving HbA1c < 7.0%
- Change in fasting plasma glucose
- Change in systolic blood pressure
- Change in fasting lipids
Population
Adults with type 2 diabetes (HbA1c 7–10.5%), BMI 23–50 kg/m², n=281
Intervention
Retatrutide 2 mg, 4 mg, 8 mg, or 12 mg SC once weekly vs. placebo; dose escalation over 24 weeks
Inclusion criteria
Adults ≥ 18 years; type 2 diabetes ≥ 6 months; HbA1c 7.0–10.5%; BMI 23–50 kg/m²; on stable metformin ± SGLT2 inhibitor; no insulin use
Exclusion criteria
Type 1 diabetes; eGFR < 45 mL/min/1.73m²; personal or family history of medullary thyroid carcinoma or MEN2; use of GLP-1 RA or GIP agonist in prior 3 months; 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.