Ascletis Pharma has received investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to begin a 13-week Phase II study of its oral small molecule glucagon-like peptide (GLP)-1, ASC30, targeting participants with type 2 diabetes (T2D) mellitus.
The placebo-controlled, randomised, double-blind trial will assess the tolerability, efficacy, and safety in approximately 100 participants across multiple centres in the US.
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Its primary endpoint is the mean change from baseline in HbA1c at 13 weeks between treatment and placebo groups. Secondary endpoints include changes in body weight and fasting blood glucose, as well as overall tolerability and safety.
Participants will be randomly assigned in a 2:3:3:2 ratio to ASC30 doses of 40mg, 60mg, and 80mg, or matching placebo tablets. Dose titration will occur weekly from 1mg up to the target doses.
Ascletis expects to start enrolment for the study in the first quarter of 2026.
Recently, the company completed a similar 13-week Phase II study for ASC30 in obesity involving 125 participants with obesity or overweight with at least one weight-related comorbidity at several US sites.
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By GlobalDataThe primary endpoint results showed dose-dependent, placebo-adjusted mean body weight reductions of 5.4%, 7.0%, and 7.7% for daily doses of 20mg, 40mg, and 60mg, respectively.
No plateau was reported for weight loss during the trial period. The vomiting rate associated with weekly titration of ASC30 was about half that reported for orforglipron under similar dosing conditions, and gastrointestinal tolerability was comparable to orforglipron titrated every four weeks in the Phase III ATTAIN-I study. Discontinuation due to adverse events occurred in 4.8% of subjects.
ASC30 is designed for once-daily oral dosing as well as once-monthly to once-quarterly subcutaneous administration for diabetes, obesity, and other metabolic diseases.
Ascletis founder, chairman and CEO Jinzi Jason Wu said: “IND clearance for this Phase II study for diabetes is a significant milestone for Ascletis as we continue to build upon the data for ASC30. Furthermore, the FDA’s clearance of our IND expands entry for ASC30 into clinical development for the large diabetes treatment market.”
