Ascletis Begins Phase Two Diabetes Drug Trial

HONG KONG, Jan. 26, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the first participants have been dosed in a U.S. 13-week Phase II study (NCT07321678) with ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist for the treatment of type 2 diabetes mellitus. Topline data from the Phase II study are expected in the third quarter of 2026.

Ascletis recently completed a 13-week Phase II study evaluating ASC30 for the treatment of obesity (NCT07002905) in 125 participants with obesity or overweight with at least one weight-related comorbidity at multiple sites across the U.S. At the 13-week primary endpoint, ASC30 once-daily tablets showed statistically significant, clinically meaningful and dose-dependent placebo-adjusted mean body weight reductions of 5.4%, 7.0% and 7.7% for 20 mg, 40 mg and 60 mg, respectively. No plateau was observed for weight loss. The vomiting rate of ASC30 titrated weekly to target dose was approximately half of the published vomiting rate observed with orforglipron titrated weekly. The gastrointestinal tolerability of ASC30 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 for the ASC30 Phase II study for obesity or overweight was 4.8%.

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.

"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."

For more information, please visit www.ascletis.com.