Ascletis Announces U.S. FDA IND Clearance for 13-Week Phase II Study of Its Oral Small Molecule GLP-1, ASC30, in Participants with Diabetes

Core Insights - Ascletis Pharma Inc. has received Investigational New Drug (IND) clearance from the U.S. FDA for its Phase II study of ASC30, an oral small molecule GLP-1 receptor agonist for type 2 diabetes [2][5] - The Phase II study will evaluate the efficacy, safety, and tolerability of ASC30 over 13 weeks, with enrollment expected to begin in Q1 2026 [2][3] Group 1: Phase II Study for Diabetes - The Phase II study is a 13-week, randomized, double-blind, placebo-controlled, multi-center trial involving approximately 100 participants with type 2 diabetes [2][3] - Primary endpoint includes mean change from baseline in HbA1c, while secondary endpoints include changes in fasting blood glucose and body weight [2][3] - Participants will be randomly assigned to receive either ASC30 at doses of 40 mg, 60 mg, or 80 mg, or matching placebo tablets [2][3] Group 2: ASC30 Efficacy in Obesity - A recently completed Phase II study for ASC30 demonstrated placebo-adjusted weight loss of 7.7% in participants with obesity or overweight [3] - The study showed statistically significant and clinically meaningful weight reductions of 5.4%, 7.0%, and 7.7% for doses of 20 mg, 40 mg, and 60 mg, respectively [3] - ASC30 exhibited better gastrointestinal tolerability compared to other treatments, with a total treatment discontinuation rate due to adverse events of 4.8% [3] Group 3: Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing therapeutics for metabolic diseases [5] - The company utilizes proprietary technologies such as Artificial Intelligence-Assisted Structure-Based Drug Discovery and Ultra-Long-Acting Platform to develop drug candidates [5] - ASC30 is part of a broader pipeline that includes other candidates targeting chronic weight management and metabolic diseases [5]