ASCLETIS-B (01672.HK): ASC30 Meets Phase II Diabetes Endpoint with 1.7% HbA1c Reduction

NewTimeSpace News: On 29 October 2026, Ascletis Pharma Inc. (stock code: 1672) published a voluntary announcement that its US Phase II study of the oral small-molecule GLP-1 receptor agonist ASC30 in type 2 diabetes (NCT07321678) achieved positive topline results, meeting the primary endpoint and all secondary endpoints.

The 13-week randomised, double-blind, placebo-controlled, multicentre study enrolled 100 patients with type 2 diabetes across US sites, randomised approximately 2:3:3:2 to ASC30 40 mg, 60 mg, 80 mg or placebo, with weekly titration from 1 mg to the maintenance dose; the primary endpoint was the change in HbA1c from baseline at week 12.

At week 12, placebo-adjusted HbA1c reductions (least squares mean) were 1.7%, 1.6% and 1.7% for the 40 mg, 60 mg and 80 mg groups (p<0.0001), from a mean baseline HbA1c of 8.3%. At week 13, placebo-adjusted body weight reductions were 4.4%, 3.8% and 4.0% (p=0.001 to 0.003) with no plateau observed, from a mean baseline weight of 93.7 kg.

Despite rapid weekly titration, ASC30 showed good gastrointestinal tolerability, with no study discontinuations due to gastrointestinal adverse events; only one discontinuation due to any adverse event occurred (1/80, 1.3%, hiccup), versus none on placebo. All drug-related adverse events were grade 1 or 2, with no related serious adverse events; no liver safety signals were observed, with no elevations in ALT, AST or total bilirubin during treatment. The global Phase III obesity programme (AURORA-1 and AURORA-2) is enrolling about 4,600 participants, with topline data expected in the third quarter of 2028, a US NDA filing by end-2028 and an EU MAA in early 2029.