Mazdutide Demonstrates Superiority to Semaglutide in Type 2 Diabetes and Obesity

Innovent Biologics, Inc.’s investigative GLP-1/glucagon (GCG) dual receptor agonist mazdutide has met its primary endpoint of superiority to semaglutide in HbA1c and body weight reduction in patients with type 2 diabetes (T2D) and comorbid obesity.1

Announced on October 26, 2025, DREAMS-3 was the fourth in a series of phase 3 clinical trials investigating mazdutide. The results showed a significantly higher proportion of participants achieved HbA1c <7% and a ≥10% body weight reduction from baseline at week 32 in the mazdutide group compared to semaglutide. Mazdutide also exhibited a consistent safety profile with previous studies, with no new safety signals identified.1

“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,” Linong Ji, Peking University People’s Hospital and principal investigator of DREAMS-3, said in a statement. “We believe that mazdutide can bring benefits to patients with T2D and comorbid obesity who are appropriate candidates for this class of therapy—to control blood glucose, effectively manage weight, and improve overall health status.”1

To be included in DREAMS-3, participants were required to have T2D diagnosed according to WHO standards in 1999, poorly controlled blood glucose after diet and exercise with or without sable metformin ≥1500 mg/day, no more than 2550 mg/day, within 3 months before screening, and a body mass index (BMI) ≥28 kg/m2. Participants with a self-reported body weight change of >5% within 3 months before screening, oral hypoglycemic drug use within 2 months, previous diagnosis of type 1 diabetes, or active or untreated malignant tumors within 5 years.2

DREAMS-3 had a primary endpoint of the proportion of subjects achieving a composite of HbA1c <7% and ≥10% weight loss. Secondary endpoints included a composite of HbA1c <7% and ≥15% weight loss, as well as change from baseline in HbA1c, fasting plasma glucose, waist circumference, body weight, systolic blood pressure, triglycerides, and total cholesterol.2

A total of 349 patients were enrolled; Ji and colleagues randomly assigned these participants in a 1:1 ratio to receive either mazdutide 6 mg or semaglutide 1 mg for 32 weeks. This was followed by an extension period during which the mazdutide arm continued treatment at different doses for another 24 weeks based on whether the weight loss target was achieved.1

Ultimately, the mean HbA1c change from baseline was recorded as -2.03% in the mazdutide group and -1.84% in the semaglutide group, respectively. Mean percentage weight reduction was 10.29% in the mazdutide group and 6% in the semaglutide group, respectively (both P <.05). The most common adverse events were gastrointestinal symptoms, almost entirely mild to moderate in severity.1

“The head-to-head DREAMS-3 study comparing mazdutide with semaglutide further showed that, in patients with T2D and comorbid obesity, mazdutide provides superior efficacy in both weight loss and glucose lowering,” Lei Qian, chief R&D officer of General Biomedicine from Innovent Biologics, said in a statement. “With successive approvals for weight management and T2D indications, we believe mazdutide will benefit a wide range of patients requiring multifaceted improvements in glycemic control, body weight, and cardiometabolic risk factors.”1

Innovent Biologics has also announced plans for future trials of mazdutide in various diseases, including metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), and obesity.1

References

1. Innovent Biologics, Inc. Innovent’s Mazdutide Shows Superiority in Glycemic Control with Weight Loss over Semaglutide in a Head-to-head Phase 3 Clinical Trial DREAMS-3. PR Newswire. October 26, 2025. Accessed October 28, 2025. https://www.prnewswire.com/news-releases/innovents-mazdutide-shows-superiority-in-glycemic-control-with-weight-loss-over-semaglutide-in-a-head-to-head-phase-3-clinical-trial-dreams-3-302594633.html

2. Innovent Biologics, Inc. A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity. ClinicalTrials.gov identifier: NCT06184568. Updated January 15, 2025. Accessed October 28, 2025. https://clinicaltrials.gov/study/NCT06184568?intr=IBI362%20&rank=6