Chinese pharmaceutical company Ascletis Pharma Inc (HKEX:1672) on Sunday announced completion of 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. Ascletis expects topline data from the Phase II study for the treatment of T2D in the third quarter of 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 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 in HbA1c from baseline up to 13 weeks in the treatment group compared with the placebo group. Secondary endpoints include the mean change in fasting blood glucose and body weight, and safety and tolerability.

The Phase II study enrolled 100 participants with type 2 diabetes mellitus at multiple sites across the United States. 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.