Core Insights - The completion of subject enrollment for the Phase IIa study of ASC30, a small molecule GLP-1 receptor agonist for obesity treatment, marks a significant milestone in its development [1][2] - ASC30 is designed as a depot formulation for subcutaneous administration once a month, with a 12-week duration study involving 65 participants [1] - The observed half-life of ASC30 is 46 days, supporting its monthly dosing regimen, while the terminal half-life is 36 days [1][2] Group 1: Study Details - The Phase IIa study is randomized, double-blind, placebo-controlled, and multi-center, aimed at assessing safety, tolerability, and efficacy in obese subjects with a BMI of ≥30 kg/m² or overweight subjects with at least one weight-related comorbidity [1] - The study is divided into three cohorts with different dosages, and top-line data is expected in Q1 2026 [1] Group 2: Drug Characteristics - ASC30 has a peak-to-trough ratio of approximately 1.5:1, indicating its pharmacokinetic profile [2] - The drug is developed using the company's proprietary Ultra Long-Acting Platform (ULAP), which overcomes limitations of albumin-dependent half-life extension technologies [2] - ASC30 is the first and only small molecule GLP-1R agonist that can be administered both orally and via subcutaneous injection, suitable for both weight loss and weight maintenance therapies [3] Group 3: Intellectual Property - ASC30 is a new chemical entity (NCE) with patent protection in the U.S. and globally, valid until 2044 without considering patent extensions [3]
歌礼制药-B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