Ascletis Announces First Participants Dosed in a 13-week U.S. Phase II Study with ASC30, an Oral Small Molecule GLP-1R Agonist for the Treatment of Diabetes

Core Insights - Ascletis Pharma Inc. is advancing its investigational drug ASC30, a GLP-1 receptor agonist, into a Phase II study for type 2 diabetes, with topline data expected in Q3 2026 [2][5] Group 1: ASC30 Development - ASC30 has shown a placebo-adjusted weight loss of up to 7.7% in a completed 13-week Phase II study for obesity, demonstrating better gastrointestinal tolerability compared to other treatments [1][3] - The Phase II study for diabetes will evaluate ASC30's efficacy, safety, and tolerability, focusing on changes in HbA1c and body weight among approximately 100 participants [5][6] - ASC30 is designed for once-daily oral administration and has been developed in-house by Ascletis as a first and only investigational small molecule GLP-1R fully biased agonist [4][6] Group 2: Clinical Study Details - The obesity Phase II study involved 125 participants and reported a treatment discontinuation rate due to adverse events of 4.8% [3] - The study for diabetes is randomized, double-blind, and placebo-controlled, with participants assigned to different dosages of ASC30 [5] - The primary endpoint of the diabetes study is the mean change in HbA1c from baseline, with secondary endpoints including fasting blood glucose and body weight changes [5]