Innovent Biologics Inc., a biopharmaceutical company based in China (HKG: 1801), has announced the first patient dosing in the Phase III GLORY-2 study, which is assessing the higher dose 9mg version of mazdutide (IBI362) for the treatment of obesity in Chinese adults. Mazdutide is a dual agonist drug candidate targeting both the glucagon-like peptide 1 receptor (GLP-1R) and the glucagon receptor (GCGR).
The study aims to enroll 450 subjects, who will be randomized to receive either mazdutide 9mg or a placebo. The primary endpoints will evaluate the percentage change in body weight from baseline to week 60 and the proportion of subjects achieving a 5% or more reduction in body weight from baseline at week 60.
A previous Phase II study conducted in Chinese individuals with obesity and a BMI ≥30 kg/m2 (NCT04904913) demonstrated that after 48 weeks of treatment, mazdutide 9mg resulted in an 18.6% placebo-adjusted mean reduction in body weight. Additionally, mazdutide was shown to reduce waist circumference, blood pressure, lipids, serum uric acid, transaminase, and liver fat, providing multiple metabolic benefits to the subjects. The drug was well tolerated, with an overall safety profile similar to other GLP-1 class drugs and no new safety signals observed.
Innovent has entered into an exclusive license agreement with Eli Lilly & Co. (Lilly, NYSE: LLY) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may increase energy expenditure and improve hepatic fat metabolism through the activation of the glucagon receptor, in addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose, and reducing body weight.- Flcube.com
