甘李药业启动中国首个每月一次GLP-1RA减重III期临床研究

Core Viewpoint - Ganli Pharmaceutical has initiated China's first Phase III clinical study for a monthly formulation of glucagon-like peptide-1 receptor agonist (GLP-1RA) called Bofanglutide, aimed at weight management, which is expected to significantly improve patient adherence to medication [1][2] Group 1: Clinical Research - The GRADUAL-3 study is a randomized controlled trial designed to evaluate the efficacy and safety of Bofanglutide administered via subcutaneous injection once a month for weight loss [1] - This study is part of a larger GRADUAL series, which includes three Phase III clinical trials in China, targeting over 1,000 adult participants who are overweight or obese [2] - The primary endpoint of the GRADUAL-3 study is the change in body weight from baseline after 24 weeks of treatment [1] Group 2: Product Advantages - Compared to existing weekly GLP-1RA formulations, the monthly injection regimen of Bofanglutide reduces the number of injections from 52 to 12 per year, decreasing injection frequency by nearly 80% [1] - This reduction in injection frequency is expected to alleviate the treatment burden and enhance the quality of life for patients, addressing a critical clinical pain point in long-term weight management [1] Group 3: Broader Innovation Strategy - Ganli Pharmaceutical's innovation in metabolic diseases extends beyond GLP-1RA, with multiple new drugs entering global development, including a fourth-generation insulin (GZR) that has reached Phase III clinical trials [2] - The GZR weekly formulation is anticipated to reduce insulin injection frequency by over 85% compared to daily formulations, significantly lowering the treatment burden for diabetes patients [2] - The company is also developing a fixed-ratio combination formulation of Bofanglutide and GZR, currently in Phase II clinical trials, reflecting its strategic vision to expand from diabetes treatment to comprehensive metabolic health management [2]