Initiation of Phase 3 Mazdutide Trial for Obesity in China

Innovent Biologics, a renowned biopharmaceutical firm, has recently initiated a Phase 3 clinical trial for mazdutide, a novel medication designed to address obesity. The trial, known as GLORY-2, marks the fourth substantial phase 3 study for this GLP-1R and GCGR dual agonist, which has shown promising results in reducing body weight and improving metabolic health in Chinese adults with obesity.

The Phase 2 study, which involved subjects with a BMI of 30 kg/m2 or higher, demonstrated that mazdutide at a dosage of 9mg led to an average weight reduction of 18.6% compared to the placebo group after 48 weeks of treatment. This effect was accompanied by a decrease in waist circumference, blood pressure, lipid levels, serum uric acid, and liver fat. The medication was well-tolerated, with a safety profile akin to other GLP-1 class drugs and no new safety concerns were raised.

Professor Linong Ji, the principal investigator from Peking University People's Hospital, highlighted the unique challenges faced by the Chinese population, where individuals tend to have higher body fat percentages and cardiovascular risks at lower BMI levels compared to Western populations. The prevalence of obesity in China is significant and continues to rise, necessitating effective clinical management and early intervention strategies for metabolic syndrome. The Phase 2 study results for mazdutide indicate its potential as a leading weight loss drug in China, particularly for those with severe obesity.

Dr. Lei Qian, Vice President of Clinical Development at Innovent, emphasized that mazdutide 9 mg is tailored to cater to the weight loss needs of individuals with moderate to severe obesity, offering a much-needed alternative to bariatric surgery. The medication's simple titration process and favorable safety profile make it a promising candidate for the treatment of obesity.

Obesity is a growing concern in China, affecting a vast number of individuals and contributing to a range of health complications that reduce life expectancy and quality of life. The lack of effective and safe long-term treatments has led to an unmet need for innovative solutions. Mazdutide, with its demonstrated efficacy in weight loss and metabolic improvements, could fill this gap.

Innovent, established in 2011, is dedicated to developing and commercializing innovative biopharmaceutical products that are accessible to the general public. The company has a diverse portfolio of 10 marketed products and several others in various stages of clinical development. Their strategic collaborations with international partners, such as Eli Lilly and Company, aim to advance the biopharmaceutical industry and enhance patient care.

Mazdutide, developed under an exclusive license agreement with Eli Lilly, is an analogue of mammalian oxyntomodulin (OXM). It works by promoting insulin secretion, reducing blood glucose and body weight, and may also increase energy expenditure and improve liver fat metabolism. The ongoing Phase 3 trials for mazdutide in overweight or obese patients, as well as those with type 2 diabetes, underscore Innovent's commitment to addressing significant health challenges with innovative solutions.