Innovent Unveils Phase 3 Mazdutide Weight Management Study Results at ADA's 84th Sessions

Innovent Biologics, Inc. (Innovent), a prominent biopharmaceutical company that focuses on creating high-quality medicines for a range of major diseases, including oncology, autoimmune disorders, cardiovascular and metabolic conditions, and ophthalmology, has shared the significant results of the first Phase 3 clinical trial of its GLP-1R/GCGR dual agonist, mazdutide, in Chinese adults with overweight or obesity. The findings were presented at the ADA Scientific Sessions 2024.

Mazdutide, known by its development code IBI362, is designed to activate both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) to promote weight loss. Activation of GLP-1R reduces appetite and delays gastric emptying, while activation of GCGR enhances energy expenditure, fatty acid oxidation, and lipolysis, and reduces liver fat.

The GLORY-1 study, a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial, enrolled 610 participants to evaluate the efficacy and safety of mazdutide. Participants were randomized to receive either 4 mg or 6 mg of mazdutide or a placebo over a 48-week treatment period. The trial met its primary and key secondary endpoints, demonstrating robust weight loss and improvements in various cardiometabolic risk factors.

At week 32 and week 48, participants receiving mazdutide showed superior weight loss compared to those on placebo. Specifically, at week 48, the mean percentage weight change for the 6 mg mazdutide group was -14.31% for the treatment-policy estimand and -14.37% for the efficacy estimand. Additionally, a significant proportion of participants achieved weight reductions of ≥5%, ≥10%, and ≥15%.

Mazdutide also led to considerable reductions in multiple cardiometabolic risk factors. For instance, waist circumference decreased by -9.48 cm with 4 mg and -10.96 cm with 6 mg of mazdutide, compared to -1.48 cm with placebo. Other improvements included reductions in systolic blood pressure, triglycerides, total cholesterol, low-density lipoprotein cholesterol, serum uric acid, and ALT levels.

The study further showcased the potential of mazdutide in reducing liver fat content. An exploratory analysis indicated an 80.2% reduction in liver fat content for participants in the mazdutide 6 mg group, compared to a 5.3% reduction with placebo.

Safety and tolerability data for mazdutide were favorable. Only a small percentage of participants discontinued the study drug prematurely due to adverse events (AEs). Common AEs were gastrointestinal in nature, such as nausea, diarrhea, and vomiting, which were mostly mild to moderate. The incidence of serious adverse events was low and comparable to placebo, with no new safety signals observed.

The promising results of the GLORY-1 trial indicate that mazdutide could be an effective and safe option for chronic weight management in adults with obesity or overweight, offering additional cardiovascular and metabolic benefits. The new drug application (NDA) for mazdutide is currently under review by the National Medical Products Administration (NMPA) of China, and if approved, it could provide a convenient medication for weight reduction among the Chinese population.

Innovent is committed to advancing its next-generation product pipeline in the cardiovascular and metabolic therapeutic areas, aiming to support healthier lifestyles and address the unmet clinical needs of patients with obesity and related conditions. The company also plans to publish further results of mazdutide in type 2 diabetes later in the year.

Obesity is recognized as a significant risk factor for numerous chronic diseases, including type 2 diabetes, fatty liver disease, cardiovascular conditions, and certain cancers. The number of obese individuals in China is the highest globally, posing a major public health challenge. Traditional pharmacological therapies in China have had limited success and presented safety concerns, highlighting the need for more effective and safe treatments like mazdutide.

Innovent Biologics, founded in 2011, has launched ten products in the market and has several new drug applications under regulatory review. The company collaborates with various global healthcare organizations to make high-quality pharmaceutical drugs widely accessible.