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.
In section Releases
Ascletis Begins Global Phase III Trials for Oral Weight-Loss Drug ASC30
Ascletis Pharma has administered the first dose in a global Phase III clinical program for ASC30, an experimental once-daily oral small molecule designed for chronic weight management. The launch of the AURORA trials marks a significant step toward providing an alternative to current injectable incretin therapies for patients worldwide.
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.
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