Key Findings
In a 13-week U.S. Phase II study (NCT07321678) involving 100 participants with type 2 diabetes (T2D), ASC30 met its primary and all secondary endpoints. The primary endpoint, HbA1c reduction at 12 weeks, showed placebo-adjusted decreases of 1.7% for the 40 mg dose, 1.6% for 60 mg, and 1.7% for 80 mg (p < 0.0001). Baseline HbA1c for participants averaged 8.3%.
Regarding the secondary endpoint of body weight reduction at 13 weeks, ASC30 achieved placebo-adjusted reductions of 4.4%, 3.8%, and 4.0% for the 40 mg, 60 mg, and 80 mg doses, respectively (p = 0.001 to 0.003). No weight loss plateau was observed during the study period; baseline average body weight was 93.7 kg.
Technical Details and Safety
ASC30 is an investigational small molecule GLP-1R fully biased agonist administered as a once-daily tablet. Despite a fast weekly titration to maintenance doses, the drug showed favorable safety and gastrointestinal (GI) tolerability. There were zero study discontinuations due to GI adverse events, and only one total discontinuation (1.3%) due to a hiccup. All drug-related adverse events were categorized as grade 1 (mild) or grade 2 (moderate), with no drug-related serious adverse events (SAEs) reported.
Hepatic safety signals were absent, with no elevations observed in alanine transaminase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBL). Ascletis expects GI tolerability to improve further in Phase III trials by slowing titration to once every four weeks.
Background and Outlook
T2D is the second indication for ASC30, following obesity. The company is currently conducting a global Phase III program for obesity (AURORA-1 and AURORA-2) in the U.S., Europe, and Canada, enrolling approximately 4,600 participants. Topline data for the obesity program are expected in Q3 2028, with an FDA New Drug Application (NDA) submission planned for late 2028 and an EMA Marketing Authorisation Application (MAA) expected in early 2029. If approved, ASC30 could become the second oral small molecule GLP-1 receptor agonist available in these markets.
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