Ascletis' Oral Small Molecule GLP-1, ASC30, Demonstrated Placebo-Adjusted Weight Loss of 7.7% with Better Gastrointestinal Tolerability in Its 13-Week U.S. Phase II Study in Participants with Obesity or Overweight

Core Insights - Ascletis Pharma Inc. announced positive topline results from its 13-week Phase II study of ASC30, an oral GLP-1 receptor agonist for obesity treatment, showing statistically significant weight loss compared to placebo [3][4][12] - ASC30 demonstrated a dose-dependent mean body weight reduction of 5.4%, 7.0%, and 7.7% for doses of 20 mg, 40 mg, and 60 mg respectively, with no observed plateau in weight loss [4][5] - The study included 125 participants with obesity or overweight and at least one weight-related comorbidity, achieving a placebo-adjusted mean weight loss of 7.7% at the highest dose [3][4] Efficacy and Safety - 80% of participants taking 60 mg of ASC30 lost at least 5% of their body weight, compared to 4.2% in the placebo group, and 45% lost 7% of their body weight [5] - ASC30 also met secondary endpoints, showing reductions in cardiovascular risk markers such as total cholesterol, LDL-C, triglycerides, and blood pressure across all doses [6] - No significant gastrointestinal adverse events were reported, with a total treatment discontinuation rate due to adverse events at 4.8% [7][8] Tolerability - The vomiting rate for ASC30 was approximately half that of orforglipron, indicating better gastrointestinal tolerability [7][10] - All gastrointestinal adverse events were mild to moderate, with no severe events reported [8][9] - The company anticipates further improvement in gastrointestinal tolerability in Phase III studies when titration is adjusted to every four weeks [9][10] Future Plans - Ascletis plans to submit the Phase II study data to the U.S. FDA and request an End-of-Phase II meeting in Q1 2026 [10] - The company is focused on developing ASC30 as a potential best-in-class treatment for chronic weight management, with ongoing research and development efforts [14]