ASCLETIS-B (01672) Announces Completion of First Dosing in 13-Week US Phase II Study of Oral Small-Molecule GLP-1R Agonist ASC30 for Diabetes

Stock News
01/26

ASCLETIS-B (01672) announced that its Board of Directors declared the completion of the first patient dosing in a 13-week US Phase II study (NCT07321678) of its oral small-molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of type 2 diabetes. Top-line data from this Phase II study are anticipated in the third quarter of 2026. The company recently concluded a separate 13-week Phase II study (NCT07002905) evaluating ASC30 for the treatment of obesity. This obesity study, conducted across multiple US centers, enrolled a total of 125 subjects with obesity or overweight accompanied by at least one weight-related comorbidity. At the 13-week primary endpoint, once-daily 20 mg, 40 mg, and 60 mg ASC30 tablets achieved placebo-adjusted mean weight reductions of 5.4%, 7.0%, and 7.7%, respectively, demonstrating statistically significant, clinically meaningful, and dose-dependent weight loss. No weight loss plateau was observed. The incidence of vomiting with ASC30, using weekly titration up to the target dose, was approximately half of the vomiting incidence observed with published data for weekly-titrated orforglipron. The gastrointestinal tolerability of weekly-titrated ASC30 was comparable to the published results for orforglipron using titration every four weeks in the Phase III ATTAIN-1 study. In the Phase II study of ASC30 for obesity or overweight, the overall discontinuation rate due to adverse events was 4.8%. Developed independently by ASCLETIS, ASC30 is the first and only small-molecule GLP-1R full biased agonist currently in clinical development that offers both once-daily oral administration and subcutaneous injection options ranging from monthly to quarterly, intended for the treatment of obesity, diabetes, and other metabolic diseases. "Expanding the clinical development of ASC30 into the vast diabetes treatment market is the logical next strategic step, providing us with another opportunity to demonstrate ASC30's potential to offer patients a best-in-class, once-daily oral therapeutic option," said Dr. Jinzi J. Wu, Founder, Chairman, and CEO of ASCLETIS. "We look forward to sharing the top-line data from the Phase II study in diabetic subjects in the third quarter of 2026."

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