Ascletis Completes Enrollment in U.S. Phase IIa Study for Its Once-Monthly Subcutaneous Depot Treatment Formulation of Small Molecule GLP-1R Agonist ASC30 for Obesity

Core Insights - Ascletis Pharma Inc. has completed enrollment in a U.S. Phase IIa study for its once-monthly subcutaneous (SQ) depot formulation of the small molecule GLP-1 receptor agonist ASC30, targeting obesity treatment [3][4] - The Phase IIa study is a 12-week, randomized, double-blind, placebo-controlled trial involving 65 participants with obesity or overweight, all having at least one weight-related comorbidity [4][3] - Topline data from the study is expected in the first quarter of 2026, marking a significant milestone in the development of ASC30 [2][7] Study Details - The Phase IIa study evaluates the efficacy, safety, and tolerability of ASC30 in participants with a body mass index (BMI) of 30 kg/m or higher, or 27 kg/m but less than 30 kg/m [4] - The study consists of three cohorts with different doses, totaling 65 participants [4] - The ultra-long-acting SQ depot formulation of ASC30 demonstrated a 46-day observed half-life in a Phase Ib study, supporting its once-monthly administration [2][5] Technology and Development - ASC30 is developed using Ascletis' Ultra-Long-Acting Platform (ULAP), which allows for a longer half-life compared to traditional albumin-dependent technologies [6][7] - The proprietary formulation shows a favorable peak-to-trough ratio of approximately 1.5 to 1, indicating its potential as a once-monthly treatment option for obesity [7][6] - ASC30 is a first and only investigational small molecule GLP-1R biased agonist designed for both oral and subcutaneous administration [9][10] Company Overview - Ascletis Pharma Inc. is a biotechnology company focused on developing therapeutics for metabolic diseases, utilizing advanced technologies such as Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) [10] - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [10]