Ascletis Begins Global Phase III Trials for Oral Weight-Loss Drug ASC30

The clinical program consists of two pivotal, multicenter, randomized, double-blind, placebo-controlled trials, AURORA-1 and AURORA-2, which will evaluate the safety and efficacy of the drug across the United States, Europe, and Canada. The study aims to enroll approximately 4,600 participants. Researchers will test three maintenance doses—20 mg, 40 mg, and 60 mg—over a 72-week treatment period to determine the drug's performance in both diabetic and non-diabetic populations.

According to Jinzi Jason Wu, CEO of Ascletis, the transition to Phase III is supported by positive results from earlier clinical stages, which demonstrated favorable gastrointestinal tolerability and no hepatic safety signals. If successful, ASC30 could become a leading oral therapy in the obesity market. The company projects topline data will be available in the third quarter of 2028, with regulatory filings for the FDA and EMA expected to follow shortly thereafter.