–Topline data from the Phase II diabetes treatment study are expected in the third quarter of 2026.

–ASC30 achieved placebo-adjusted weight loss of up to 7.7% in a recently completed 13-week U.S. Phase II study in participants with obesity or overweight, with improved gastrointestinal tolerability. No hepatic safety signal was observed.

HONG KONG, Jan. 25, 2026 — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announced that the first participants have been dosed in a 13-week U.S. Phase II study of ASC30, an oral small-molecule GLP-1 receptor (GLP-1R) agonist for the treatment of type 2 diabetes mellitus. Topline data from this Phase II study are expected in the third quarter of 2026.

Ascletis recently completed a 13-week Phase II study evaluating ASC30 for obesity treatment in 125 participants with obesity or overweight (each with at least one weight-related comorbidity) across multiple U.S. sites. At the 13-week primary endpoint, once-daily ASC30 tablets delivered statistically significant, clinically meaningful, and dose-dependent placebo-adjusted mean body weight reductions of 5.4%, 7.0%, and 7.7% for the 20 mg, 40 mg, and 60 mg doses, respectively. No weight loss plateau was observed. The vomiting rate of weekly-titrated ASC30 was approximately half that of weekly-titrated orforglipron (per published data). ASC30’s gastrointestinal tolerability when titrated weekly was comparable to published results of orforglipron titrated every four weeks in the Phase III ATTAIN-1 study. The total treatment discontinuation rate due to adverse events in this obesity/overweight Phase II study was 4.8%.

ASC30 was discovered and developed in-house at Ascletis as the first and only investigational small-molecule GLP-1R fully biased agonist, with dosing options including once-daily oral administration and once-monthly to once-quarterly subcutaneous injection for the treatment of obesity, diabetes, and other metabolic diseases.

“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,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, “We look forward to sharing topline data from the Phase II study in diabetes participants in the third quarter of 2026.”

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, multi-center trial to evaluate the efficacy, safety, and tolerability of ASC30 tablets in participants with type 2 diabetes mellitus. Its primary endpoint is the mean change from baseline in HbA1c over 13 weeks for the treatment group versus the placebo group. Secondary endpoints include: the mean change from baseline in fasting blood glucose over 13 weeks (treatment vs. placebo), the mean change from baseline in body weight over 13 weeks (treatment vs. placebo), and safety and tolerability. The study will enroll approximately 100 participants with type 2 diabetes at multiple U.S. sites. Participants will be randomly assigned in an approximate 2:3:3:2 ratio to 40 mg, 60 mg, or 80 mg ASC30 tablets, or matching placebo tablets, respectively. ASC30 will be 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), Ultra-Long-Acting Platform (ULAP), and Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house—including small molecules and peptides. These include its lead program ASC30 (a small-molecule GLP-1R agonist designed for once-daily oral use and once-monthly to once-quarterly subcutaneous injection as a treatment and maintenance therapy for chronic weight management); ASC36 (a once-monthly subcutaneous amylin receptor peptide agonist); ASC35 (a once-monthly subcutaneous GLP-1R/GIPR dual peptide agonist); and ASC37 (a GLP-1R/GIPR/GCGR triple peptide agonist for chronic weight management). Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).

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Contact Details:

Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)

Ascletis Pharma Inc. PR & IR Teams
+86-181-0650-9129 (China)

SOURCE Ascletis Pharma Inc.