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– This 13-week U.S. Phase II study is evaluating the efficacy, safety, and tolerability of ASC30 tablets, a once-daily oral small-molecule GLP-1R agonist, in 100 diabetic subjects.
– Topline data from this Phase II study are expected in the third quarter of 2026.
“The efficacy and tolerability demonstrated by ASC30 in the U.S. Phase II study in obese or overweight subjects prove its potential to become a best-in-class oral small-molecule GLP-1 drug for the treatment of obesity,” said Dr. Jinzi Wu, Founder, Board Chairman, and CEO of Ascletis Pharma. “Expanding the clinical development of ASC30 into the vast diabetes treatment market is a logical next strategic step, offering us another opportunity to highlight ASC30’s potential to provide patients with a best-in-class once-daily oral therapy option. We look forward to sharing topline data from the Phase II study in diabetic subjects in the third quarter of 2026.”
Dr. Wu added: “Based on the positive clinical results from the 13-week U.S. Phase II study of ASC30 in obese or overweight subjects announced in December 2025, the company expects to obtain U.S. Food and Drug Administration approval and initiate a Phase III trial for the obesity indication in the United States by the end of the third quarter of 2026.”
ASC30, independently developed by Ascletis, is the first and only small-molecule GLP-1R full biased agonist in clinical research that can be administered both once-daily orally and once-monthly to once-quarterly subcutaneously for the treatment of obesity, diabetes, and other metabolic diseases.
About the U.S. Phase II Study of ASC30 for Diabetes
This Phase II study is a 13-week, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy, safety, and tolerability of ASC30 tablets in subjects with type 2 diabetes. The primary endpoint of this Phase II study is the mean change from baseline in glycated hemoglobin (HbA1c) at week 13 in the treatment group compared to the placebo group. Secondary endpoints include: mean change from baseline in fasting plasma glucose at week 13 in the treatment group compared to the placebo group; mean change from baseline in body weight at week 13 in the treatment group compared to the placebo group; and safety and tolerability. This Phase II study enrolled 100 subjects with type 2 diabetes at multiple centers in the United States. Subjects were randomized in an approximately 2:3:3:2 ratio to receive 40 mg, 60 mg, and 80 mg of ASC30 tablets or matching placebo (tablets), respectively. ASC30 was titrated weekly from 1 mg to target doses of 40 mg, 60 mg, and 80 mg.
About Ascletis Pharma Inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of drugs that have the potential to be best-in-class and first-in-class for the treatment of metabolic diseases. Leveraging its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD), Ultra-Long-Acting Platform (ULAP) technology, and Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has independently developed multiple small-molecule and peptide drug candidates, including its core program ASC30, an investigational small-molecule GLP-1R agonist that can be administered both once-daily orally and once-monthly to once-quarterly subcutaneously as a weight loss therapy and weight maintenance therapy for long-term weight management; ASC36, an amylin receptor agonist peptide; ASC35, a once-monthly subcutaneous GLP-1R/GIPR dual agonist peptide; ASC37, a GLP-1R/GIPR/GCGR triple agonist peptide; ASC39, a potent oral small-molecule amylin receptor agonist selective for amylin; and ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 and ASC39 for long-term weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).
For more information, please visit the website: www.ascletis.com.
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