ASCLETIS-B (01672) has announced that patient enrollment has been completed for its 13-week US Phase II clinical study (NCT07321678) evaluating the oral small-molecule GLP-1 receptor agonist ASC30 for the treatment of type 2 diabetes. This represents the second indication for ASC30, following obesity, which was its initial target. Top-line data from this Phase II study in type 2 diabetes are expected in the third quarter of 2026.

The efficacy and tolerability demonstrated by ASC30 in a US Phase II study involving subjects with obesity or overweight support its potential to become a best-in-class oral small-molecule GLP-1 therapy for obesity, stated Dr. Jinzi J. Wu, Founder, Chairman, and CEO of ASCLETIS. Expanding the clinical development of ASC30 into the substantial diabetes treatment market is a logical next strategic step, providing another opportunity to highlight its potential as a best-in-class, once-daily oral treatment option for patients. We look forward to sharing the top-line data from the Phase II study in diabetic subjects in Q3 2026.

Dr. Wu added that, based on positive clinical results from the 13-week US Phase II study of ASC30 in obese or overweight subjects announced in December 2025, the company anticipates receiving US Food and Drug Administration approval and initiating a Phase III trial for the obesity indication in the US by the end of the third quarter of 2026.

Developed independently by ASCLETIS, ASC30 is the first and only small-molecule GLP-1 receptor full biased agonist currently in clinical development that can be administered either as a once-daily oral dose or as a subcutaneous injection ranging from once monthly to once quarterly, intended for the treatment of obesity, diabetes, and other metabolic disorders.