Ascletis Pharma has completed subject enrolment in its 13-week US Phase II study of ASC30, an oral small molecule GLP-1 receptor agonist, as a treatment for type 2 diabetes mellitus (T2DM).
The double-blind, randomised, multi-centre, placebo-controlled trial will evaluate the safety, tolerability, and efficacy of ASC30 tablets.
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The primary endpoint measures the mean change in HbA1c at 13 weeks compared to placebo.
Secondary endpoints assess changes in fasting blood glucose and body weight, as well as safety and tolerability.
The trial enrolled 100 participants with T2DM at various locations throughout the US.
They were randomly assigned in a 2:3:3:2 ratio to receive daily doses of 40mg, 60mg, or 80mg ASC30, or a matching placebo, with doses titrated weekly from 1mg up to the target doses.
Ascletis expects topline results from the study in the third quarter of 2026.
Ascletis developed ASC30 internally as the first and only investigational small molecule GLP-1R fully biased agonist, designed for once-daily oral dosing and once-monthly to once-quarterly subcutaneous administration for obesity, diabetes and other metabolic diseases.
Ascletis founder, chairman and CEO Jinzi Jason Wu 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 II 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.”
Earlier this year, Ascletis announced positive top line results from its Phase III open-label trial assessing the long-term safety of denifanstat (ASC40) in patients with moderate to severe acne vulgaris.
