Genentech Announces Positive Phase II Results for Its Dual GLP-1/GIP Receptor Agonist CT-388 in People Living With Obesity

Core Insights - Genentech 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 weight loss without reaching a plateau at 48 weeks [1][2][3] Company Overview - Genentech, a member of the Roche Group, is a leading biotechnology company focused on discovering, developing, manufacturing, and commercializing medicines for serious medical conditions [8] Clinical Trial Results - The Phase II trial (CT388-103) involved 469 participants and demonstrated a placebo-adjusted weight loss of 22.5% for the efficacy estimand and 18.3% for the treatment-regimen estimand at the 24 mg dose [1][6] - At week 48, 95.7% of participants treated with CT-388 achieved at least a 5% weight loss, with 87% achieving 10%, 47.8% achieving 20%, and 26.1% achieving 30% [1] - Among 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 and a low discontinuation rate due to adverse events (5.9% in CT-388 arms vs. 1.3% in placebo) [2] Future Development - Genentech has fast-tracked CT-388 and is advancing to Phase III trials, with additional studies evaluating its efficacy in participants with obesity and type 2 diabetes [5] - The Phase III clinical trial program (Enith1 and Enith2) is expected to start this quarter [5] Industry Context - Obesity is a significant global health risk, with projections indicating over four billion people will be living with excess weight or obesity by 2035, increasing the burden on healthcare systems [4]