ASCLETIS-B (01672) announced that the first batch of subjects in the 13-week Phase II study of the oral small molecule GLP-1R agonist ASC30 for the treatment of diabetes has been dosed in the United States.

ASCLETIS-B (01672) has announced that its oral small molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of type 2 diabetes in the US 13-week Phase II study (NCT07321678) has completed dosing for the first group of subjects. The top-line data for this Phase II study is expected to be available in the third quarter of 2026. Gala recently completed a 13-week Phase II study (NCT07002905) evaluating ASC30 for the treatment of obesity. The study was conducted at multiple centers in the US, with a total of 125 obese subjects or overweight subjects with at least one weight-related comorbidity. At the primary endpoint at week 13, daily doses of 20 mg, 40 mg, and 60 mg ASC30 tablets resulted in placebo-corrected average weight loss of 5.4%, 7.0%, and 7.7%, respectively, with statistically significant, clinically meaningful, and dose-dependent weight loss. No weight loss plateau was observed. The incidence of vomiting with weekly titration to target dose of ASC30 was approximately half of the incidence observed with orforglipron. The gastrointestinal tolerability of ASC30 with weekly titration was comparable to the results of the III phase ATTAIN-1 study with orforglipron titrated every four weeks. The overall discontinuation rate due to adverse events in the Phase II study of ASC30 for the treatment of obesity or overweight was 4.8%. ASC30, developed by Gala, is the first and only small molecule GLP-1R biased agonist in clinical development that can be administered orally once daily or subcutaneously once a month to once every quarter, for the treatment of obesity, diabetes, and other metabolic diseases. "Expanding the clinical development of ASC30 to the vast diabetes treatment market is the logical next strategic step, providing us with another opportunity to showcase ASC30 as a potential best-in-class once-daily oral therapy option for patients," said Dr. Jinzi Wu, founder, chairman, and CEO of Gala. "We look forward to sharing the top-line data from the Phase II study conducted in diabetes patients in the third quarter of 2026."