Mazdutide Outperforms Dulaglutide in Chinese Type 2 Diabetes: Phase 3 DREAMS-2 Results Presented at EASD 2024

Innovent Biologics, Inc. (Innovent), a prominent biopharmaceutical company, announced significant findings from the Phase 3 clinical trial of mazdutide, a dual agonist targeting glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), in Chinese adults with type 2 diabetes (T2D). The results were disclosed at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD). The study, named DREAMS-2, demonstrated that mazdutide was superior to dulaglutide in both glycemic control and weight reduction.

The DREAMS-2 study involved 731 Chinese participants aged around 51.8 years, all of whom had T2D inadequately managed with metformin or other oral anti-diabetic medications. Participants were divided to receive either 4 mg or 6 mg of mazdutide or 1.5 mg of dulaglutide over a period of 28 weeks. The primary aim was to observe changes in HbA1c levels from baseline to the end of the study.

The findings revealed that mazdutide outperformed dulaglutide in lowering HbA1c levels. After 28 weeks, participants receiving 4 mg and 6 mg of mazdutide saw average HbA1c reductions of 1.69% and 1.73%, respectively, compared to 1.36% for those on dulaglutide. Furthermore, a higher percentage of participants on mazdutide achieved HbA1c levels below 7.0% and 6.5% than those on dulaglutide.

Mazdutide also proved more effective in weight reduction. Participants on 4 mg and 6 mg of mazdutide experienced average weight losses of 9.24% and 7.13%, respectively, compared to 2.86% for the dulaglutide group. Additionally, a significant proportion of mazdutide users achieved a weight reduction of 5% or more, with many also achieving concurrent improvements in HbA1c levels.

The study also highlighted mazdutide's impact on various cardiometabolic risk factors. Treatment with mazdutide resulted in notable improvements in fasting glucose, postprandial glucose, waist circumference, blood pressure, lipid profiles, serum uric acid, and liver enzymes. These benefits were generally more pronounced than those achieved with dulaglutide.

In terms of safety, mazdutide was well tolerated, with mostly mild to moderate gastrointestinal symptoms being the most common side effects. Importantly, there were no new safety signals, and the incidence of severe hypoglycemia was not reported with mazdutide, paralleling the safety profile observed in previous clinical trials.

Mazdutide is currently the first GLP-1R/GCGR dual agonist under regulatory review, with applications for chronic weight management and T2D treatment submitted to the National Medical Products Administration (NMPA) in China. The principal investigator of the study, Professor Lixin Guo from Beijing Hospital, emphasized the high incidence of T2D in China and noted the significant benefits that GLP-1 receptor agonists provide in managing diabetes and related conditions. He lauded mazdutide for its superior efficacy in glucose control and weight management, expressing optimism for its potential availability as a new treatment option.

Dr. Lei Qian, Vice President of Clinical Development at Innovent, recognized the urgent need for effective diabetes treatments in China due to the country's large diabetic population. He noted that the positive results from the mazdutide trials underscore its potential to offer comprehensive benefits in glycemic control, weight loss, and various metabolic indicators.

Innovent Biologics, founded in 2011, is dedicated to developing and commercializing affordable, high-quality biopharmaceuticals. The company focuses on creating innovative treatments for cancer, cardiovascular and metabolic diseases, autoimmune disorders, and ophthalmology conditions. Innovent has successfully launched multiple products and continues to advance numerous clinical-stage drugs through its robust pipeline, aiming to address some of the most challenging health conditions globally.

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