Ascletis Pharma Inc. (Ascletis, HKEX: 01672) has commenced dosing in a pivotal global Phase III programme evaluating ASC30, its proprietary once-daily oral small-molecule GLP-1 receptor agonist for chronic weight management and diabetes.
The clinical programme comprises two randomised, double-blind, placebo-controlled trials—AURORA-1 (NCT07743463) and AURORA-2 (NCT07743450)—that will recruit approximately 4,600 adults across the United States, Europe and Canada. Participants will receive one of three maintenance doses of ASC30 (20 mg, 40 mg or 60 mg) or placebo over 72 weeks.
• AURORA-1 targets adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m² with at least one weight-related comorbidity) without type 2 diabetes; the primary endpoint is percentage change in body weight from baseline at Week 72. • AURORA-2 evaluates the same dosing regimen and endpoint in adults with obesity or overweight who also have type 2 diabetes.
Ascletis expects topline data in Q3 2028, followed by a U.S. FDA New Drug Application submission by end-2028 and an EMA Marketing Authorisation Application in early 2029. Management stated that current cash resources are sufficient to fund operations through 2029, covering the development and planned regulatory filings.
If approved, ASC30 could become the second oral small-molecule GLP-1 agonist available in the U.S. and Europe. The candidate demonstrated competitive Phase II weight-loss results, favourable gastrointestinal tolerability and no hepatic safety concerns, according to the company.
Beyond monotherapy, Ascletis is developing complementary fixed-dose oral combinations, including dual GLP-1/GIP (ASC30_48FDC), triple GLP-1/GIP/amylin (ASC30_48_39FDC) and a GLP-1/amylin regimen (ASC30_39FDC), aimed at broadening its obesity and metabolic disease portfolio.
Ascletis cautions that successful development, manufacturing and commercialisation of ASC30 and its combination candidates are not guaranteed.