Ascletis Pharma Inc. (ASCLETIS-B) reported positive topline results from a 13-week, randomized, double-blind, placebo-controlled Phase II trial (NCT07321678) of its oral small-molecule GLP-1 receptor agonist ASC30 in 100 U.S. patients with type 2 diabetes mellitus (T2D).
At the primary 12-week endpoint, ASC30 achieved statistically significant, placebo-adjusted reductions in glycated hemoglobin (HbA1c) of 1.70 percentage points at 40 mg (n=20), 1.60 points at 60 mg (n=29) and 1.70 points at 80 mg (n=28) versus placebo (p < 0.0001 across doses). Participants entered the study with a mean baseline HbA1c of 8.30%.
For the key secondary endpoint, ASC30 produced placebo-adjusted body-weight reductions at 13 weeks of 4.40% (40 mg), 3.80% (60 mg) and 4.00% (80 mg) (p = 0.001–0.003). The mean baseline body weight was 93.70 kg, and no weight-loss plateau was observed across doses.
Safety and tolerability were favorable. Weekly titration from 1 mg to target doses resulted in zero treatment discontinuations due to gastrointestinal adverse events. Only one participant (1.3%) discontinued for any adverse event (hiccup), all drug-related adverse events were Grade 1–2, and no drug-related serious adverse events or hepatic safety signals (ALT, AST, TBL elevations) were recorded.
ASC30, discovered and developed in-house by Ascletis, is also in a global Phase III obesity program (AURORA-1 and AURORA-2) spanning the U.S., Europe and Canada with approximately 4,600 participants. Topline data are expected in Q3 2028, supporting potential FDA and EMA submissions by late 2028 and early 2029, respectively. If approved, ASC30 could become the second oral small-molecule GLP-1 receptor agonist available in the U.S. and Europe.
The company underscores that ASC30’s profile—combining clinically meaningful HbA1c and weight reductions with mild adverse events—supports continued development as a once-daily oral therapy for T2D and obesity.
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