Ascletis announces FDA approval of IND for a 13-week Phase II study of its oral small molecule GLP-1, ASC30, in diabetic subjects

Hong Kong, January 5, 2026 -- Ascletis Pharma Inc. (HKEX code: 1672, referred to as 'Ascletis') announced today that it has recently received FDA approval for an Investigational New Drug (IND) application for its Phase II study of the oral small molecule GLP-1, ASC30, in diabetic subjects. This Phase II study is a 13-week, randomized, double-blind, placebo-controlled, and multi-center study designed to evaluate the efficacy, safety, and tolerability of ASC30 in type 2 diabetic subjects. The primary endpoint of this Phase II study is the mean change from baseline in HbA1c at week 13 compared to the placebo group. Secondary endpoints include: the mean change from baseline in fasting blood glucose at week 13 compared to the placebo group; the mean change from baseline in body weight at week 13 compared to the placebo group; as well as safety and tolerability. This Phase II study will enroll approximately 100 type 2 diabetic subjects across multiple centers in the United States. Subjects will be randomly assigned in an approximate ratio of 2:3:3:2 to treatment groups receiving 40 mg, 60 mg, and 80 mg of ASC30 tablets and a matched placebo group. ASC30 will start at 1 mg and will be titrated weekly to target doses of 40 mg, 60 mg, and 80 mg. Subject enrollment is expected to begin in the first quarter of 2026.

ASC30, independently developed by Ascletis, is the first and only small-molecule GLP-1R full biased agonist currently in clinical research that can be administered either once daily orally or once a month to once a quarter via subcutaneous injection for the treatment of obesity, diabetes, and other metabolic diseases.

Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class drugs for metabolic diseases. Leveraging proprietary technologies such as Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD), Ultra-Long-Acting Platform (ULAP), and Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has independently developed multiple small-molecule and peptide candidates, including its core project ASC30, an investigational small-molecule GLP-1R agonist that can be administered orally once daily or subcutaneously once monthly to quarterly for weight loss treatment and maintenance therapy, intended for long-term weight management; ASC36, a once-monthly subcutaneous injectable amylin receptor agonist peptide; ASC35, a once-monthly subcutaneous injectable GLP-1R/GIPR dual-target agonist peptide; and ASC37, an orally administered GLP-1R/GIPR/GCGR triple-target agonist peptide for long-term weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).