Roche’s CT-388 Obesity Drug Achieves 22.5% Weight Loss in Phase II, Advances to Phase III

Roche's dual GLP-1/GIP agonist CT-388 achieved placebo-adjusted weight loss of 22.5% at 48 weeks in a Phase II trial, with no plateau observed134.

Over 95% of patients lost more than 5% body weight, 48% lost over 20%, and 26% lost 30% or more; 73% of pre-diabetic patients normalized blood glucose14.

The drug was well-tolerated with mild to moderate GI side effects and 5.9% discontinuation rate13.

Roche plans to start Phase III trials (Enith1 and Enith2) in Q1 2026134.

CT-388 originates from Roche's acquisition of Carmot Therapeutics and is being combined with Zealand Pharma's petrelintide1.

Sources:

1. https://www.biospace.com/drug-development/roches-22-weight-loss-benefit-seals-glp-1s-phase-iii-plans-boosts-zealand-combo

3. https://www.biopharmadive.com/news/roche-obesity-drug-phase-2-data-carmot-glp-gip/810578/

4. https://www.pharmexec.com/view/roche-positive-topline-results-phase-ii-study-dual-glp-gip-receptor-agonist