Ascletis Pharma has completed the enrollment in its 13-week US Phase 2 study (NCT07321678) 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 2 study for the treatment of T2D are expected in the third quarter of 2026.

Speaking in this regard, Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO, Ascletis, said, “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 2 study in participants with obesity or overweight. 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 2 study in diabetes participants in the third quarter of 2026."

Dr. Wu added, "Based on the positive clinical results announced in December 2025 from our 13-week US phase 2 study of ASC30 in participants with obesity or overweight, the company expects to obtain the clearance from the US Food and Drug Administration (FDA) and initiate phase 3 trials in the US for obesity indication by the end of the third quarter 2026."

ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R fully biased agonist that can be dosed once daily orally and once monthly to once quarterly subcutaneously for the treatment of obesity, diabetes and other metabolic diseases.

The phase 2 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 T2D. The primary endpoint of the phase 2 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 2 study enrolled 100 participants with T2D 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.