[Ad hoc announcement pursuant to Art. 53 LR] Roche announces positive Phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity

Core Insights - Roche announced positive topline results from a Phase II clinical trial of CT-388, a dual GLP-1/GIP receptor agonist for obesity treatment, showing significant placebo-adjusted weight loss of 22.5% at 48 weeks [1][7] - The treatment demonstrated a well-tolerated safety profile, with a low discontinuation rate due to adverse events [2] Clinical Trial Results - The Phase II trial involved 469 participants with obesity, showing a clear dose-response relationship with a maximum dose of 24 mg [6] - At week 48, 95.7% of participants on the 24 mg dose achieved a weight loss of ≥5%, 87% achieved ≥10%, 47.8% achieved ≥20%, and 26.1% achieved ≥30% [1] - For pre-diabetic participants, 73% achieved normal blood glucose levels compared to 7.5% in the placebo group [1] Safety and Tolerability - The treatment was well-tolerated, with mild-to-moderate gastrointestinal-related adverse events consistent with the incretin class of medicines [2] - The discontinuation rate due to adverse events was low at 5.9% for CT-388 and 1.3% for the placebo [2] Future Development - Roche has fast-tracked CT-388's clinical development and plans to initiate Phase III trials (Enith1 and Enith2) this quarter [5] - An additional Phase II study (CT388-104) is ongoing to evaluate CT-388 in participants with obesity or overweight and type 2 diabetes [5] Industry Context - Obesity is recognized as a significant global health risk, with projections indicating over four billion people will be living with excess weight or obesity by 2035 [4] - The rise in obesity is attributed to a mix of genetic, biological, behavioral, environmental, and socioeconomic factors, increasing the burden on healthcare systems [4]