Ascletis Pharma has dosed the first participants in a US Phase II trial of ASC30, an oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist, intended for treating type 2 diabetes mellitus.
The company plans to release top line data from this 13-week Phase II study in the third quarter of 2026.
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The Phase II double-blind, randomised, multi-centre, placebo-controlled study will assess the safety, tolerability and efficacy of ASC30 tablets.
Its primary endpoint is the mean change from baseline in glycated haemoglobin (HbA1c) at week 13 versus placebo. Secondary endpoints include changes from baseline in fasting blood glucose and body weight at week 13, along with tolerability and safety evaluations.
Around 100 participants with type 2 diabetes mellitus will be enrolled across US sites. They will be randomised in a ratio of around 2:3:3:2 to receive 40mg, 60mg and 80mg ASC30 tablets and a placebo. Weekly titration will begin at 1mg to target doses.
Ascletis previously completed a separate 13-week Phase II trial of ASC30 targeting obesity involving 125 participants who are overweight and have at least one weight-related comorbidity across multiple sites in the US.
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By GlobalDataASC30 is described by Ascletis as a small molecule GLP-1R fully biased agonist able to be administered either once daily orally or via subcutaneous injection once monthly to quarterly for diabetes, obesity and other metabolic diseases.
Ascletis founder, chairman and CEO Jinzi Jason Wu said: “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 top line data from the Phase II study in diabetes participants in the third quarter of 2026.”
In July 2025, Ascletis dosed the first obese or overweight subjects in the 13-week, multi-centre Phase IIa trial of ASC30 in the US.
