Ascletis Pharma Inc. has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration for a 13-week Phase II clinical study of its oral small molecule GLP-1 receptor agonist, ASC30, in participants with type 2 diabetes mellitus.
The Phase II trial will be a randomized, double-blind, placebo-controlled, multi-centre study designed to evaluate the efficacy, safety and tolerability of ASC30 in people with diabetes. The primary endpoint will assess the mean change in HbA1c from baseline at 13 weeks compared with placebo. Secondary endpoints include changes in fasting blood glucose, body weight, and overall safety and tolerability.
The study is expected to enroll around 100 participants across multiple sites in the United States. Participants will be randomly assigned to receive ASC30 at doses of 40 mg, 60 mg or 80 mg, or matching placebo, in a ratio of approximately 2:3:3:2. ASC30 will be titrated weekly from an initial dose of 1 mg to the target doses. Enrollment is expected to begin in the first quarter of 2026.
The IND clearance follows the recent completion of a separate 13-week U.S. Phase II study of ASC30 in participants with obesity or overweight and at least one weight-related comorbidity. In that study, ASC30 demonstrated statistically significant and dose-dependent placebo-adjusted weight loss of 5.4 per cent, 7.0 per cent and 7.7 per cent at doses of 20 mg, 40 mg and 60 mg, respectively. No plateau in weight reduction was observed at the 13-week endpoint.
The obesity study also reported favorable gastrointestinal tolerability, with vomiting rates approximately half of those reported for comparable oral GLP-1 therapies using weekly titration schedules. No hepatic safety signals were observed, and the treatment discontinuation rate due to adverse events was 4.8 per cent.
ASC30 is an investigational small molecule GLP-1 receptor agonist discovered and developed in-house by Ascletis. It is designed as a fully biased agonist that can be administered once daily orally, with potential for longer-acting subcutaneous dosing intervals ranging from once monthly to once quarterly. The candidate is being developed for the treatment of diabetes, obesity and other metabolic diseases.
