SAN FRANCISCO and SUZHOU, China, June 24, 2024 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, presents the key results of the first Phase 3 clinical trial of mazdutide in Chinese adults with overweight or obesity (GLORY-1) at the ADA Scientific Sessions 2024.
The primary endpoints and all key secondary endpoints of GLORY-1 were met, reconfirming the unique advantages of the GLP-1R/GCGR dual agonist
Mazdutide (Innovent R&D code: IBI362) is a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist. By activating GLP-1R, it reduces appetite and delays gastric emptying, thereby achieving weight loss. At the same time, through activation of GCGR, it increases energy expenditure, enhances fatty acid oxidation and lipolysis, and reduces liver fat.
The results of the GLORY-1 study demonstrated that mazdutide not only induced robust weight loss in adults with obesity or overweight, but also reduced liver fat content and multiple cardiometabolic risk factors. Its first new drug application (NDA) for chronic weight management is under review by the CDE of the National Medical Products Administration (NMPA). Mazdutide, once approved, is expected to provide a safe and convenient medication for adults with obesity or overweight to effectively reduce body weight while providing cardiovascular and metabolic benefits.
Full results and analysis of GLORY-1 will be published at peer-reviewed academic journals. At present, over 1,500 subjects have received doses of mazdutide in 17 clinical trials, providing solid clinical evidence for weight management and diabetes treatment in China.
GLORY-1 (NCT05607680) is a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy and safety of mazdutide in Chinese adults with overweight or obesity. A total of 610 participants were randomized to receive mazdutide 4 mg, 6 mg or placebo in the 48-week double-blind treatment period.
Mazdutide showed robust weight loss efficacy
At week 32 and week 48, the weight loss efficacy of mazdutide 4mg and 6mg were superior to placebo in the mean percentage change in body weight from baseline, and percentage of participants achieved body weight reduction ≥5%, ≥10% and ≥15% (P