Workflow
国内GLP-1创新减重药研究首次登上国际顶刊，有望年内获批上市
Di Yi Cai Jing·2025-05-26 07:29

Core Insights - The clinical study of the innovative weight-loss drug, Masitide, developed in China, has reached international leading status, potentially transforming clinical treatment and guidelines for overweight and obesity both domestically and internationally [1][4]. Group 1: Clinical Study Details - The study published in the New England Journal of Medicine (NEJM) is led by Professor Ji Linong from Peking University People's Hospital and is the first Phase III, double-blind, placebo-controlled trial (GLORY-1) assessing the efficacy and safety of Masitide in overweight or obese Chinese participants [1][4]. - The GLORY-1 trial set a weight loss target of 5%-15% within 3-6 months for overweight and mildly obese patients, with nearly half of the participants achieving a weight loss greater than 15% [4][5]. Group 2: Drug Development and Market Potential - Masitide is the world's first and only GCG/GLP-1 dual receptor agonist for weight loss and glycemic control, co-developed by Innovent Biologics and Eli Lilly, with commercialization rights in China secured in 2019 [4]. - The drug is expected to be approved for market in China this year, targeting both weight loss and glycemic control indications [4]. Group 3: Research Significance and Global Recognition - The publication of the GLORY-1 study in a prestigious journal signifies international recognition of China's innovative research in the field of endocrine metabolism [5]. - The study highlights the unique characteristics and treatment needs of the Chinese population regarding obesity, contrasting with existing guidelines primarily based on data from Caucasian populations [4][5]. Group 4: Comparative Efficacy - At 48 weeks of treatment, the proportion of participants achieving at least 15% weight loss in the 4mg and 6mg Masitide groups were 35.7% and 49.5%, respectively [5]. - In comparison, a recent head-to-head study of competing GLP-1 weight-loss drugs showed that 64.6% and 40.1% of patients achieved similar weight loss with alternative treatments [5].