Mazdutide Phase 3 Trial Success in Chinese Overweight/Obesity, NDA to NMPA Planned

Innovative pharmaceutical company Innovent Biologics has reported positive results from the first Phase 3 clinical trial of mazdutide, a dual GLP-1R and GCGR agonist, in addressing weight concerns among Chinese adults. The trial, known as GLORY-1, was a randomized, double-blind, placebo-controlled study involving 610 participants. Over a 48-week period, the trial evaluated the drug's efficacy and safety, with participants receiving either 4 mg or 6 mg of mazdutide or a placebo.

The study successfully met its primary goals, showing that both dosages of mazdutide were more effective than the placebo in terms of percentage body weight change from baseline to week 32 and the percentage of participants achieving at least a 5% weight loss by week 32. The drug's performance continued to improve from week 32 to week 48.

In addition to the primary endpoints, the trial also achieved all key secondary endpoints. These included the proportion of participants with a weight loss of 10% or more, changes in waist circumference, systolic blood pressure, triglycerides, LDL cholesterol, total cholesterol, serum uric acid, and alanine aminotransferase levels. Mazdutide proved superior to the placebo across all these metrics.

The safety profile of mazdutide during the trial was consistent with previous findings, with no new safety concerns raised. This Phase 3 success marks a significant milestone for mazdutide as the first GLP-1R/GCGR dual agonist to reach this stage. The trial's results reinforce the drug's efficacy and safety in a substantial population and provide valuable clinical evidence for long-term pharmacotherapy for weight management among Chinese individuals with overweight or obesity.

The study's leading principal investigator, Professor Linong Ji from Peking University People's Hospital, emphasized the importance of public awareness about the chronic nature of obesity and the need for long-term, science-backed treatment and management strategies. He expressed satisfaction with the trial's outcomes, which align with the results from previous phase 2 trials of mazdutide.

Dr. Lei Qian, Vice President of Clinical Development at Innovent, highlighted the drug's pioneering role in the next generation of weight-loss medications. With clinical data from over a thousand Chinese participants, the GLORY-1 study's results indicate mazdutide's strong efficacy and favorable safety profile. Innovent is preparing to submit an NDA for mazdutide for weight management and is committed to offering a safe and effective treatment option for overweight or obese individuals in China.

Obesity, a chronic condition with various causes, is a significant risk factor for numerous health issues, including type 2 diabetes, fatty liver, heart diseases, and certain cancers. The prevalence of obesity in China has increased dramatically with economic growth and lifestyle changes, making it a pressing health concern. While lifestyle interventions are the first line of treatment, many individuals struggle to achieve their weight loss goals and may require pharmaceutical interventions. Current treatments in China have limitations, indicating a need for more effective and safer options.

Mazdutide, developed under an exclusive license agreement with Eli Lilly and Company, is an analogue of mammalian oxyntomodulin. It has shown promising effects on insulin secretion, blood glucose levels, body weight reduction, energy expenditure, and liver fat metabolism. With ongoing Phase 3 trials for both overweight or obesity and type 2 diabetes, the drug has the potential to become a leading treatment in the cardiovascular and metabolic fields.

Innovent Biologics, founded in 2011, is dedicated to developing and commercializing affordable, high-quality biopharmaceutical products. With a diverse portfolio of products and ongoing collaborations with international partners, the company is well-positioned to contribute to the advancement of the biopharmaceutical industry and improve patient care.