Ascletis Starts Phase III Trial of Oral GLP-1 Drug

Hong Kong, China, August 30, 2026

Global Phase III Program Targets 4,600 Participants

The AURORA Phase III program consists of two pivotal multicenter trials designed to evaluate the long-term efficacy, safety and tolerability of once-daily oral ASC30 over 72 weeks. AURORA-1 will evaluate participants with obesity or overweight without type 2 diabetes, while AURORA-2 will investigate ASC30 in adults with obesity or overweight who also have type 2 diabetes. Across both trials, participants will be randomized to one of three maintenance doses—20 mg, 40 mg or 60 mg of ASC30—or placebo. The primary endpoint for both pivotal studies is the percentage change in body weight from baseline to Week 72. AURORA-1 is enrolling adults with a BMI of at least 30 kg/m², or a BMI of at least 27 kg/m² accompanied by at least one weight-related comorbidity. AURORA-2 evaluates participants with obesity or overweight and type 2 diabetes. The randomized, double-blind and placebo-controlled design is intended to provide comparative data on the potential benefits and risks of long-term treatment with the investigational oral therapy.

ASC30 Advances as Oral GLP-1 Option

ASC30 is an investigational proprietary oral small-molecule GLP-1R agonist discovered and developed in-house by Ascletis. The company describes ASC30 as a fully biased GLP-1R agonist and the lead program within its broader portfolio of oral small-molecule therapies targeting obesity and metabolic diseases. Ascletis is developing the candidate as a once-daily tablet, an approach intended to provide an oral alternative to injectable incretin-based therapies if clinical development and regulatory review are successful.The company said the Phase III program builds on its reported Phase II weight-loss results, favorable gastrointestinal tolerability profile and the absence of observed hepatic safety signals. However, these observations come from the company’s development program, and the safety and efficacy of ASC30 have not been established for regulatory approval. The Phase III trials are expected to provide substantially broader evidence regarding long-term treatment outcomes, tolerability and safety across people living with obesity or overweight. Ascletis is also developing additional oral small-molecule combination programs designed to target multiple metabolic pathways, including GLP-1/GIP, GLP-1/GIP/amylin and GLP-1/amylin combinations. These programs form part of the company’s strategy to develop potentially convenient once-daily treatment options for chronic weight management.

Regulatory Submissions Planned for 2028 and 2029

Ascletis expects to report topline data from the AURORA Phase III program in the third quarter of 2028. Subject to the clinical results and regulatory requirements, the company expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2028, followed by a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in early 2029. If approved, ASC30 could potentially become the second oral small-molecule GLP-1 receptor agonist available in the United States and Europe, according to Ascletis. The company said it has sufficient cash resources to support operations into 2029 and expects to fully fund the ASC30 Phase III program beyond the planned U.S. and European regulatory submissions. The initiation of AURORA-1 and AURORA-2 therefore marks an important transition from mid-stage clinical development to pivotal Phase III testing for ASC30. Results from the approximately 4,600-participant program will be closely watched as the company evaluates whether its once-daily oral GLP-1 approach can demonstrate clinically meaningful and durable weight reduction while maintaining an acceptable safety and tolerability profile.

Source: Ascletis Pharma press relese