Ascletis Announces First Participant Dosed in a Global Phase III Clinical Program of Once-Daily Oral Small Molecule GLP-1 Receptor Agonist ASC30 for Chronic Weight Management

Ascletis Pharma Inc. has initiated its global Phase III clinical program for ASC30, an investigational oral small molecule glucagon-like peptide-1 receptor (GLP-1R) agonist aimed at chronic weight management. The program is expected to enroll approximately 4,600 participants diagnosed with obesity or overweight across two pivotal trials, AURORA-1 and AURORA-2, which will take place in the U.S., Europe, and Canada.

The clinical trials will evaluate the efficacy and safety of three maintenance doses (20 mg, 40 mg, and 60 mg) of ASC30 over a duration of 72 weeks. AURORA-1 will focus on participants with obesity or overweight without type 2 diabetes, while AURORA-2 will involve participants who do have type 2 diabetes. Topline data from these trials is anticipated in the third quarter of 2028.

Jinzi Jason Wu, Ph.D., the Founder, Chairman, and CEO of Ascletis, emphasized the ongoing global health burden of obesity and the need for effective treatments. He noted that injectable therapies have advanced obesity care, but there remains a significant demand for an oral medication that is effective, well-tolerated, and convenient for patients.

Ascletis plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2028, along with a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in early 2029, if the trials are successful. The company retains a robust financial position to support the clinical program and related operations into 2029.

In addition to the AURORA global Phase III trials, Ascletis is developing several other oral small molecule therapies for obesity, including combinations targeting GLP-1, GIP, and amylin, enhancing its comprehensive portfolio in this therapeutic area.