Overview
- At the highest tested dose of 24 mg, CT-388 achieved a 22.5% placebo-adjusted weight reduction at 48 weeks by the efficacy estimand, with weight loss not yet plateauing.
- Using the treatment‑regimen estimand that counts discontinuations, the placebo‑adjusted reduction was 18.3% with p < 0.001.
- Responder rates at 48 weeks for 24 mg were 95.7% for ≥5% weight loss, 87% for ≥10%, 47.8% for ≥20%, and 26.1% for ≥30%.
- Gastrointestinal side effects were mostly mild to moderate and consistent with incretin drugs, with discontinuations due to adverse events at 5.9% for CT‑388 versus 1.3% for placebo.
- Roche plans to start the Enith1 and Enith2 Phase 3 obesity trials this quarter, and an additional Phase 2 study in people with type 2 diabetes is ongoing.