Ascletis Completes Enrollment in U.S. Phase IIa Study for Its Small Molecule Oral GLP-1R Agonist, ASC30, in Participants with Obesity or Overweight

Core Insights - Ascletis Pharma Inc. has completed enrollment for its 13-week Phase IIa study of ASC30, a small molecule oral GLP-1 receptor agonist aimed at treating obesity, with 125 participants enrolled in just over one month [2][3]. Group 1: Study Details - The Phase IIa study is randomized, double-blind, placebo-controlled, and multi-center, focusing on participants with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m² but < 30 kg/m²) who have at least one weight-related comorbidity [3][4]. - Two oral formulations of ASC30 are being evaluated: formulation 1 (ASC30 tablets) and formulation 2 (ASC30 tablets A1), with a primary endpoint of mean percentage body weight change from baseline at Week 13 [3][4]. - The study protocol starts with a low dose of 1 mg for both formulations, with weekly titrations to maintenance doses of 20 mg and 40 mg for formulation 1, and 20 mg, 40 mg, and 60 mg for formulation 2 [3]. Group 2: Product Information - ASC30 is a first and only investigational small molecule GLP-1R biased agonist, designed for both once-daily oral and once-monthly subcutaneous injection dosing options for obesity treatment [4][5]. - The compound has U.S. and global patent protection until 2044, ensuring its exclusivity in the market [5]. Group 3: Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing therapeutics for metabolic diseases, utilizing proprietary platforms for drug discovery [6]. - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [6].