Overview
- In a 48-week, placebo-controlled trial of 469 adults without type 2 diabetes, the highest 24 mg dose produced a 22.5% placebo-adjusted weight loss by the efficacy estimand and 18.3% by the treatment-regimen estimand.
- Responder rates at 24 mg were 95.7% for at least 5% weight loss, 87% for at least 10%, 47.8% for at least 20%, and 26.1% for at least 30%, with 54% achieving a BMI below 30 kg/m2.
- Among participants with prediabetes at baseline, 73% on CT-388 normalized blood glucose at week 48 versus 7.5% on placebo.
- Safety was generally consistent with incretin therapies, with mostly mild-to-moderate gastrointestinal events and discontinuations due to adverse events of 5.9% on CT-388 versus 1.3% on placebo.
- Roche plans to begin the Enith1 and Enith2 Phase 3 program this quarter, is running a separate Phase 2 study in people with type 2 diabetes, and will present full data at an upcoming medical meeting.