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– 13-week U.S. Phase II study is evaluating the efficacy, safety and tolerability of oral small molecule GLP-1R agonist ASC30, a once-daily tablet, in 100 participants with diabetes.
– Topline data from the Phase II study are expected in the third quarter of 2026.
HONG KONG, April 27, 2026 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today completion of enrollment in its 13-week U.S. Phase II study (NCT07321678) evaluating ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist, for the treatment of type 2 diabetes mellitus (T2D). T2D is the second indication for ASC30, following its first indication of obesity. Topline data from the Phase II study for the treatment of T2D are expected in the third quarter of 2026.
“ASC30 has potential to be the best-in-class oral small molecule GLP-1 for obesity, evidenced by its efficacy and tolerability demonstrated by the U.S. Phase II study in participants with obesity or overweight,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, “Expanding ASC30’s clinical development into the large diabetes treatment market is a logical next step that provides us with another chance to highlight ASC30’s potential best-in-class profile as a once-daily oral treatment option for patients. We look forward to sharing topline data from the Phase II study in diabetes participants in the third quarter of 2026.”
Dr. Wu added, “Based on the positive clinical results announced in December 2025 from our 13-week U.S. Phase II study of ASC30 in participants with obesity or overweight, the Company expects to obtain the clearance from the U.S. Food and Drug Administration and initiate Phase III trials in the U.S. for obesity indication by the end of the third quarter 2026.”
ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R fully biased agonist that can be dosed 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 with ASC30 for the Treatment of Diabetes
The Phase II study is a 13-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the efficacy, safety, and tolerability of ASC30 tablets in participants with type 2 diabetes mellitus. The primary endpoint of the Phase II study is the mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group. Secondary endpoints include the mean change from baseline in fasting blood glucose up to 13 weeks in the treatment group compared with the placebo group, the mean change from baseline in body weight up to 13 weeks in the treatment group compared with placebo group, and safety and tolerability. The Phase II study enrolled 100 participants with type 2 diabetes mellitus at multiple sites across the U.S. Participants were randomly assigned in a ratio of approximately 2:3:3:2 to 40 mg, 60 mg and 80 mg ASC30 tablets and 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 potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, an amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, ASC39, a potent and amylin-selective oral small molecule amylin receptor agonist, and ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 and ASC39, for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).
For more information, please visit www.ascletis.com.
Contact:
Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com
Ascletis Pharma Inc. PR and IR Teams
+86-181-0650-9129 (China)
pr@ascletis.com
ir@ascletis.com
