Ascletis begins dosing participants in Phase II trial of ASC30 for diabetes

Ascletis has dosed the first participants in a US Phase II study of ASC30 for type 2 diabetes, a 13-week randomized, placebo-controlled trial, and expects to report top-line data in the third quarter of 2026.

Ascletis Pharma has commenced dosing of the first participants in a US Phase II clinical trial of ASC30, an oral small-molecule GLP-1 receptor agonist being developed for type 2 diabetes. The company describes ASC30 as a GLP-1R fully biased agonist that can be given once daily orally or by subcutaneous injection on a monthly-to-quarterly schedule. The 13-week study follows an earlier 13-week Phase II trial of ASC30 in people who are overweight or obese. Ascletis' leadership said expanding ASC30's development into diabetes is a logical next step and the company plans to share top-line results in the third quarter of 2026. Key details: - Study design: double-blind, randomized, multi-centre and placebo-controlled over 13 weeks. - Primary endpoint: mean change from baseline in glycated haemoglobin (HbA1c) at week 13 versus placebo. - Secondary endpoints: changes in fasting blood glucose and body weight at week 13, plus tolerability and safety assessments. - Enrollment and dosing: about 100 participants with type 2 diabetes across US sites, randomized roughly 2:3:3:2 to receive 40 mg, 60 mg, 80 mg ASC30 or placebo. - Titration: weekly dose titration will start at 1 mg and escalate to target doses. - Timeline: top-line data from the 13-week study is expected in the third quarter of 2026. Summary: The trial advances ASC30's clinical testing into the diabetes population and will evaluate glycaemic control and safety over 13 weeks. Top-line results are scheduled for release in the third quarter of 2026, and further development steps were not specified.