Core Viewpoint - The completion of subject enrollment in the Phase IIa study of ASC30, a small molecule GLP-1 receptor agonist for obesity treatment, marks a significant milestone in the development of this innovative therapy [1][2]. Group 1: Study Details - The Phase IIa study is a 12-week, randomized, double-blind, placebo-controlled, multi-center clinical trial conducted in the U.S. with 65 participants, all of whom are either obese or overweight with at least one weight-related comorbidity [1]. - The study aims to evaluate the safety, tolerability, and efficacy of ASC30 in subjects with a body mass index (BMI) of ≥ 30 kg/m² or those with a BMI between 27 kg/m² and 30 kg/m² [1]. - Top-line data from the study is expected in the first quarter of 2026 [1]. Group 2: Pharmacokinetics and Technology - The observed half-life of ASC30 in obese subjects is 46 days, supporting a once-monthly dosing regimen, while the terminal half-life is 36 days [1]. - The peak-to-trough ratio of the drug is approximately 1.5:1, indicating favorable pharmacokinetic properties [2]. - ASC30 is developed using the company's proprietary ultra-long-acting drug development platform (ULAP), which overcomes limitations of albumin-dependent half-life extension technologies [2]. Group 3: Product Characteristics - ASC30 is the first and only small molecule GLP-1 receptor agonist that can be administered both orally and via subcutaneous injection, suitable for both weight loss treatment and maintenance [2][3]. - The compound is a new chemical entity (NCE) with patent protection in the U.S. and globally until 2044, excluding any patent extensions [3].
歌礼制药-B(01672)完成小分子GLP-1R激动剂ASC30治疗肥胖症的每月一次皮下储库型治疗制剂的美国IIa期研究受试者入组