The pharmaceutical company Roche has released positive topline data from its Phase II clinical trial (CT388-103) evaluating CT-388, an investigational dual agonist targeting both GLP-1 and GIP receptors. The results indicate that this once-weekly injectable therapy achieves significant, dose-dependent weight reduction and metabolic improvements in adults living with obesity or overweight conditions.
CT-388 functions by activating two key pathways involved in energy balance: reducing appetite and regulating blood glucose levels. The molecule was specifically engineered to minimize receptor desensitization, potentially allowing for sustained pharmacological potency over longer periods.
Key performance metrics at week 48:
-
Weight Reduction: Participants receiving the 24 mg dose achieved a placebo-adjusted mean weight loss of 22.5%. Significantly, the weight loss trajectory showed no signs of plateauing by the end of the 48-week period.
-
Clinical Thresholds: 95.7% of treated individuals lost at least 5% of their body weight, while 26.1% reached a substantial weight reduction of 30% or more.
-
Metabolic Benefits: Among participants with pre-diabetes at the start of the study, 73% achieved normal blood glucose levels by week 48, compared to only 7.5% in the placebo group.
The study involved 469 adults in a randomized, double-blind, placebo-controlled setting. The safety profile remained consistent with the established incretin class of medications. Roche plans to advance CT-388 into a comprehensive Phase III clinical program, titled Enith1 and Enith2, starting in the first quarter of 2026.