Ascletis Launches Global Phase III Trials for Oral Obesity Drug ASC30

The AURORA-1 and AURORA-2 trials will evaluate the long-term efficacy and safety of ASC30 over a 72-week period, testing three distinct maintenance doses against a placebo. These trials focus on two key cohorts: patients with obesity or overweight without type 2 diabetes, and those living with the condition. Ascletis anticipates topline data by the third quarter of 2028, with regulatory filings in the U.S. and Europe projected to follow in late 2028 and early 2029, respectively.

Beyond the ASC30 program, the company reported promising preclinical data for its oral triple-agonist combination, which targets GLP-1, GIP, and amylin receptors. In non-human primate studies, this triple-action candidate demonstrated significant body weight reduction, outperforming dual-agonist combinations. According to Jinzi Jason Wu, CEO of Ascletis, the firm’s strategy centers on creating a comprehensive portfolio of once-daily oral small molecules, designed to offer a more convenient alternative to current injectable standards like tirzepatide.