Ascletis reported positive results from its Phase Ib multiple ascending dose (MAD) study of the oral GLP-1R agonist, ASC30, at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) on September 16, 2025. The data showed significant body weight reduction and a favorable safety profile in participants with obesity after four weeks of treatment.

The Phase Ib MAD study is a randomized, double-blind, placebo-controlled trial conducted in the United States to evaluate the safety, tolerability, pharmacokinetics (PK), titration schemes and preliminary efficacy of ASC30 once-daily oral tablets in participants with obesity (BMI: 30–40 kg/m²).

Results demonstrated that ASC30 achieved meaningful placebo-adjusted weight reductions after 28 days of treatment. In cohort 2, where participants underwent weekly titrations of 2 mg, 10 mg, 20 mg and 40 mg, the once-daily oral tablet achieved a 6.5 percent mean reduction in body weight from baseline. In cohort 1, with weekly titrations of 2 mg, 5 mg, 10 mg and 20 mg, ASC30 achieved a 4.5 percent mean weight reduction. Importantly, no sign of plateau was observed at Day 29, suggesting continued potential for weight loss with longer treatment.

Pharmacokinetic analyses confirmed that ASC30 at 20 mg and 40 mg demonstrated a superior oral PK profile at steady state, with higher drug exposure (AUC) correlating positively with greater body weight reduction.

No serious adverse events were reported. There were no Grade 3 or higher adverse events, no liver enzyme elevations, and no abnormalities detected in laboratory tests, vital signs, ECGs, or physical examinations.

“We are very excited to present clinical data of ASC30 at this year’s EASD Annual Meeting,” said Dr. Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis. “The promising efficacy and safety profile of ASC30 once again demonstrates our strong R&D capabilities and commitment to developing differentiated treatment options for obesity. We look forward to reporting topline results from the 13-week Phase IIa study of ASC30 oral tablet in the fourth quarter of this year.”