Innovent Biologics, Inc., a leading biopharmaceutical company focused on developing and commercializing high-quality medicines, announced that its fourth Phase 3 clinical trial, DREAMS-3, evaluating mazdutide, a dual glucagon-like peptide-1 (GLP-1) and glucagon (GCG) receptor agonist met its primary endpoint.
In Chinese patients with type 2 diabetes (T2D) and obesity, mazdutide demonstrated superior efficacy to semaglutide in the proportion of participants achieving both HbA1c < 7.0% and ≥10% body weight reduction at week 32 — 48.0% in the mazdutide group versus 21.0% in the semaglutide group.
At week 32, the mean change in HbA1c from baseline was −2.03% with mazdutide and −1.84% with semaglutide, while the mean weight reduction from baseline was 10.29% for mazdutide and 6.00% for semaglutide. The overall safety profile of mazdutide was consistent with previous studies, with no new safety signals identified. Gastrointestinal symptoms were the most common adverse events, generally mild to moderate in severity.
Professor Linong Ji, Principal Investigator of DREAMS-3 from Peking University People’s Hospital, noted the growing challenge of managing both diabetes and obesity in China. He stated that combined treatment strategies addressing glycemic control and weight loss are increasingly vital for improving outcomes in patients with T2D and comorbid obesity.
He emphasized:
“As the world’s first approved GCG/GLP-1 dual receptor agonist, mazdutide has demonstrated superior efficacy in glucose lowering and weight loss over semaglutide in the latest Phase 3 clinical trial. Mazdutide also provides multiple metabolic benefits and has a favorable safety profile, making it a new-generation GLP-1-based therapy suitable for Chinese patients.”
Dr. Lei Qian, Chief R&D Officer of General Biomedicine at Innovent Biologics, added:
“Mazdutide is the world’s first and only approved GCG/GLP-1 dual receptor agonist indicated for both weight management and the treatment of T2D. The DREAMS-3 study further showed its superior efficacy in both weight loss and glucose lowering. With approvals for weight management and T2D, mazdutide will benefit a wide range of patients requiring multifaceted improvements in glycemic control, body weight, and cardiometabolic risk factors.”
DREAMS-3 is a multi-center, randomized, open-label Phase 3 study enrolling 349 Chinese adults with early-stage T2D and obesity, who had inadequate glycemic and weight control after lifestyle intervention with or without metformin monotherapy. Participants were randomized 1:1 to receive mazdutide 6 mg or semaglutide 1 mg for 32 weeks. The primary endpoint was the proportion achieving HbA1c < 7.0% and ≥10% weight reduction at week 32. In the extension period, participants initially on mazdutide continued treatment for another 24 weeks at different doses based on weight-loss target achievement.
Mazdutide is a dual GCG/GLP-1 receptor agonist developed under an exclusive license agreement between Innovent Biologics and Eli Lilly and Company for China. As a mammalian oxyntomodulin (OXM) analogue, it not only promotes insulin secretion and reduces blood glucose and body weight but may also increase energy expenditure and improve hepatic fat metabolism through glucagon receptor activation. Clinical studies have shown that mazdutide can reduce waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes, liver fat content, and improve insulin sensitivity.
