Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the first Phase III clinical study for mazdutide (IBI362), a dual agonist targeting both the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR), has successfully met its primary endpoints and all key secondary endpoints in Chinese adults with overweight or obesity in the GLORY-1 trial. The company plans to submit the new drug application (NDA) for mazdutide for weight management to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) in the near future.
The GLORY-1 study (NCT05607680) was a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of mazdutide in overweight or obese Chinese adults. A total of 610 participants were randomized to receive mazdutide at doses of 4 mg or 6 mg, or a placebo, over a 48-week double-blind treatment period. The study achieved both primary endpoints, demonstrating superiority of mazdutide over placebo in terms of percentage change in body weight from baseline to week 32 and the proportion of participants achieving a weight loss of ≥5% at week 32. The weight-loss efficacy of mazdutide was further enhanced from week 32 to week 48.
Moreover, the study met all key secondary endpoints, including the proportion of participants with a weight loss of ≥10% or ≥15%, as well as improvements in waist circumference, systolic blood pressure, triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), total cholesterol, serum uric acid, and alanine aminotransferase (ALT). Mazdutide demonstrated superiority over placebo in all above weight-loss and cardiometabolic endpoints.
The safety profile of mazdutide during the double-blind treatment period was consistent with previous clinical studies, with no new safety signals detected.
Mazdutide, a mammalian oxyntomodulin (OXM) analogue, not only promotes insulin secretion, lowers blood glucose, and reduces body weight like other GLP-1 receptor agonists but also has the potential to increase energy expenditure and improve hepatic fat metabolism through the activation of the glucagon receptor.- Flcube.com
