Roche Reports Positive Phase II Results for CT-388 in Obesity

Roche has announced encouraging topline data from its Phase II trial of CT-388, a once-weekly subcutaneous injection for adults with obesity or overweight plus at least one comorbidity (excluding type 2 diabetes).

The randomized, double-blind, multi-center study enrolled 469 participants. At 48 weeks, those receiving up to 24 mg of CT-388 achieved placebo-adjusted weight loss of 22.5% (efficacy estimand) and 18.3% (treatment-regimen estimand). A dose-response relationship for weight loss was observed.

Among participants with pre-diabetes at baseline, 73% reached normal blood glucose with CT-388 versus 7.5% with placebo. Gastrointestinal adverse events were mostly mild-to-moderate, with a 5.9% discontinuation rate in the CT-388 groups versus 1.3% for placebo.

Roche plans to present full results at a medical congress and is advancing Phase III trials (Enith1 and Enith2) this quarter. CT-388 is also being investigated in overweight/obese adults with type 2 diabetes and as a combination asset with petrelintide.

31-01-2026