China-based Innovent Biologics Inc., (HKG: 1801), has announced that a Phase II clinical study assessing the higher dose (9mg) of mazdutide (IBI362) in Chinese adults with obesity has achieved its 24-week primary endpoint. This milestone marks a significant step forward in the development of this potential treatment for obesity.
Study Design and Participant Demographics
The study was a randomized, double-blind, placebo-controlled Phase II trial designed to evaluate the efficacy and safety of mazdutide 9mg in Chinese subjects with obesity, defined as a body mass index (BMI) of ≥30.0 kg/m². A total of 80 subjects with a mean baseline weight of 96.9 kg, mean height of 168.0 cm, and mean BMI of 34.3 kg/m² were enrolled and randomized in a 3:1 ratio to either the mazdutide 9 mg group or the placebo group. Participants received treatment once a week for 24 weeks, with an option to extend treatment to 48 weeks.
Primary Endpoint and Efficacy Results
The primary endpoint of the study was the percent change in body weight from baseline versus placebo after 24 weeks of treatment. Results demonstrated that mazdutide 9mg showed superior body weight loss compared to placebo in Chinese subjects with obesity. After 24 weeks, the treatment difference in mean percent change in body weight from baseline versus placebo was -15.4% (95%CI: -18.8%, -11.9%), P<0.0001. The treatment difference in mean change in body weight from baseline versus placebo was -14.7 kg (95%CI: -17.9 kg, -11.5 kg), P<0.0001. Notably, 81.7%, 65.0%, 31.7%, and 21.7% of subjects in the mazdutide 9 mg group achieved 5% or more, 10% or more, 15% or more, and 20% or more weight loss from baseline, respectively, while no subject in the placebo group lost 5% or more of body weight from baseline.
Safety and Tolerability
The overall tolerability and safety of mazdutide 9mg were favorable. Apart from COVID-19 infection, the most common adverse events are gastrointestinal related adverse events, most of which are mild or moderate and short-lived.
Partnership with Eli Lilly and Company
Innovent has entered into a licensing agreement with Eli Lilly and Company (Lilly) 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 glucagon receptor, in addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose, and reducing body weight. Mazdutide has shown excellent weight loss and glucose-lowering effects in clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, and improving insulin sensitivity, offering multiple metabolic benefits.
Ongoing Studies
Currently, three key phase 3 studies of mazdutide 4 mg and 6 mg in Chinese patients with overweight or obesity (GLORY-1) and type 2 diabetic (DREAM-1 and DREAM-2) subjects are underway. Additionally, the Phase 2 clinical study of mazdutide 9 mg in Chinese patients with obesity is in progress.-Fineline Info & Tech
