Ascletis Reports Positive Phase II Diabetes Results for Oral GLP-1 Candidate ASC30

Ascletis Pharma Inc. announced positive topline results from its U.S. Phase II study evaluating ASC30, an oral small molecule GLP-1 receptor agonist, for type 2 diabetes mellitus. The 13-week study assessed the efficacy, safety, and tolerability of once-daily tablets in 100 participants.

According to the company, the trial met its primary endpoint of HbA1c reduction at 12 weeks and secondary weight reduction endpoints at 13 weeks.

Key Study Findings

• HbA1c Reduction: Placebo-adjusted reductions from baseline at 12 weeks were 1.7% for the 40 mg dose, 1.6% for the 60 mg dose, and 1.7% for the 80 mg dose.
• Body Weight Loss: Placebo-adjusted weight reductions at 13 weeks were 4.4% (40 mg), 3.8% (60 mg), and 4.0% (80 mg), with no observed plateau.
• Safety and Tolerability: All drug-related adverse events were grade 1 or 2 in severity, with zero study discontinuations due to gastrointestinal adverse events despite fast weekly titration.

Next Steps and Future Outlook

Ascletis anticipates that gastrointestinal tolerability may improve further in future Phase III programs when titration speeds are slowed. The company continues to develop ASC30 for multiple indications, including ongoing global Phase III obesity trials, with topline data expected in the third quarter of 2028. Regulatory submissions in the U.S. and Europe remain planned for late 2028 and early 2029, respectively. Interested readers can verify original announcements through investor relations updates on the Ascletis official website.