Ascletis completes enrolment in US Phase II Study of ASC30

Ascletis Pharma has completed enrolment in its 13-week US Phase II study evaluating ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist, for the treatment of type 2 diabetes mellitus (T2D). T2D is the second indication for ASC30, following its first indication of obesity. Topline data from the Phase II study for the treatment of T2D are expected in the third quarter of 2026.

The Phase II study is a 13-week, randomised, double-blind, placebo-controlled and multi-centre study to evaluate the efficacy, safety, and tolerability of ASC30 tablets in participants with type 2 diabetes mellitus. The primary endpoint of the Phase II study is the mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group.

Secondary endpoints include the mean change from baseline in fasting blood glucose up to 13 weeks in the treatment group compared with the placebo group, the mean change from baseline in body weight up to 13 weeks in the treatment group compared with placebo group, and safety and tolerability. The Phase II study enrolled 100 participants with type 2 diabetes mellitus at multiple sites across the US. Participants were randomly assigned in a ratio of approximately 2:3:3:2 to 40 mg, 60 mg and 80 mg ASC30 tablets and matching placebo tablets, respectively. ASC30 was titrated weekly from 1 mg to target doses of 40 mg, 60 mg and 80 mg.

"ASC30 has potential to be the best-in-class oral small molecule GLP-1 for obesity, evidenced by its efficacy and tolerability demonstrated by the US Phase II study in participants with obesity or overweight," said Dr Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis, "Expanding ASC30's clinical development into the large diabetes treatment market is a logical next step that provides us with another chance to highlight ASC30's potential best-in-class profile as a once-daily oral treatment option for patients. We look forward to sharing topline data from the Phase II study in diabetes participants in the third quarter of 2026."

Based on the positive clinical results announced in December 2025 from its 13-week US Phase II study of ASC30 in participants with obesity or overweight, the company expects to obtain the clearance from the FDA and initiate Phase III trials in the US for obesity indication by the end of the third quarter 2026.