Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the results of a Phase 3 clinical study of mazdutide , a dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, in Chinese adults with overweight or obesity (GLORY-1) have been published in The New England Journal of Medicine (NEJM) with a related editorial [https://www.nejm.org/doi/full/10.1056/NEJMoa2411528]. The first authors of this paper are Professor Linong Ji from Peking University People’s Hospital and Professor Jiang Hongwei from the First Affiliated Hospital of Henan University of Science and Technology. In addition, Professor Linong Ji and Dr. Lei Qian from Innovent Biologics, served as the co-corresponding authors.
This marks the first time that a clinical study of mazdutide, the world’s first dual GCG/GLP-1 receptor agonist submitted for marketing, has been featured in a top-tier, peer-reviewed medical journal. It is also the first time a clinical trial of an innovative metabolic and endocrine therapy developed in China has been published in NEJM, a milestone that highlights China’s growing capabilities in drug development and biotechnology innovation. This publication is expected to contribute to the evolving global clinical guidelines for the treatment of overweight and obesity.
Regarding this groundbreaking new study, Professors Vanita R. Aroda of Harvard Medical School and Brigham and Women’s Hospital, Boston, and Leigh Perreault of the University of Colorado Anschutz Medical Campus jointly commented that the GLORY-1 trial reveals distinct characteristics in the Chinese population compared to Western populations. Specifically, younger individuals in China exhibit metabolic dysfunction at rates comparable to or even exceeding those in older Western populations. The dual GCG/GLP-1 receptor agonist therapy demonstrated not only significant reductions in body weight and BMI but also comprehensive improvements in obesity-associated systemic health risks. Moreover, they emphasized that obesity interventions in China must adopt differentiated strategies tailored to local population features, with a focus on liver health and lipid management. Given the earlier onset of obesity in China and its heavier societal burden, earlier intervention is critical—and yields greater long-term benefits. For emerging obesity therapies, the experts noted that pharmacological treatments are only one component of a broader strategy. They advocated for synergizing drug therapies with public health policies to build a comprehensive prevention and treatment system, addressing the global obesity epidemic more effectively.
Mazdutide is expected to launch in China this year, with anticipated approvals for weight management and glycemic control. Recognized for its superior weight loss efficacy and comprehensive metabolic benefits, mazdutide has been ranked among FIERCE Pharma’s 2025 Top 10 Most Anticipated Drugs.
In the GLORY-1 study, a total of 610 participants with obesity (BMI ≥ 28 kg/m2) or overweight (24 kg/m2 ≤ BMI < 28 kg/m2) with at least one obesity-related comorbidity were enrolled and randomized to receive mazdutide 4 mg, 6 mg, or placebo, administered subcutaneously once weekly for 48 weeks. The co-primary endpoints were the percentage change in body weight from baseline and a weight reduction of ≥5% at week 32.
At baseline, the mean weight was 87.2 kg, and the mean BMI was 31.1 kg/m 2. The study results showed that mazdutide significantly reduced body weight compared to placebo at both 4 mg and 6 mg doses.
Based on the efficacy estimand, the mean percent change from baseline in body weight was −10.97%, −13.38%, and −0.24% at Week 32 and −12.05%, −14.84%, and −0.47% at Week 48 in the mazdutide 4 mg, 6 mg, and placebo groups, respectively. A total of 76.3% of participants in the mazdutide 4 mg group and 84.0% in the mazdutide 6 mg group had a weight reduction of ≥5% at week 32, compared with 10.9% in the placebo group; 37.0% of participants in the mazdutide 4 mg group and 50.6% in the mazdutide 6 mg group had a weight reduction of ≥15% at week 48, compared with 2.1% in the placebo group.
The primary endpoint and all key secondary endpoints of the study showed statistically significant superiority to placebo with p-values < 0.001 (main results as follows).
Mazdutide also significantly reduced blood pressure, blood lipids (total cholesterol, triglycerides, and low-density lipoprotein cholesterol), serum uric acid, transaminase levels, and other cardiovascular and metabolic indicators.
In addition, mazdutide significantly reduced liver fat content.
- Among participants with baseline liver fat content ≥ 5%, the mean percent changes in liver fat content from baseline to week 48 were −63.26%, −73.18%, and +8.20% in the mazdutide 4 mg, 6 mg, and placebo groups, respectively;
- Among participants with baseline liver fat content ≥ 10%, the mean percent change from baseline in liver fat content to week 48 were −65.85%, −80.24%, and −5.27% in the mazdutide 4 mg, 6 mg, and placebo groups, respectively.
Good overall safety and tolerability of mazdutide were reported.
- The overall safety profile of the mazdutide group was consistent with findings from previous studies of mazdutide and aligned with that of other GLP-1 receptor agonists. The most frequently reported treatment-emergent adverse events included nausea, diarrhea, and vomiting, which were mostly mild or moderate in severity.
- At Week 48, both the mean change from baseline in heart rate was 2.6 beats per minute in both the mazdutide 4 mg and 6 mg groups. There were no safety signals of increased cardiovascular risk observed throughout the study.
Professor Linong Ji, the Leading Principal Investigator of the Study, Peking University People’s Hospital, stated, “For decades, global obesity management guidelines have predominantly relied on data from Caucasian populations, resulting in limited applicability to Asian demographics. Meanwhile, China’s overweight/obese population exhibits distinct clinical characteristics and therapeutic needs compared to Western populations, necessitating evidence-based weight management strategies specifically tailored for Chinese patients. For most Chinese patients with overweight or obesity, the recommended weight loss target should be 5%-15% reduction maintained over 3-6 months. Moderate-to-severe obesity patients may require more ambitious goals. The GLORY-1 study, conducted in Chinese populations aligned with these targets, demonstrated promising outcomes: mazdutide achieved >15% weight reduction in nearly half of participants, indicating its efficacy across people living with overweight to severe obesity.
Published in The New England Journal of Medicine, the GLORY-1 study not only signifies international recognition of China’s innovative research in endocrine-metabolic disorders but also underscores the pioneering innovation of Chinese biopharmaceutical industry. Mazdutide’s successful development will accelerate domestic enterprises’ strategic presence in obesity management, enabling comprehensive, personalized solutions for China’s overweight/obese population throughout their treatment journey.”
Dr. Lei Qian from Innovent Biologics, stated, “Mazdutide is globally first dual GCG/GLP-1 receptor agonist to be approved soon. The publication of its pivotal study GLORY-1 in The New England Journal of Medicine marks a breakthrough in China’s drug development in endocrine and metabolic diseases. The study provides robust, high-quality clinical evidence for treating overweight and obesity in Chinese adults and will undoubtedly influence future clinical guidelines, diagnostic criteria, and standards of care. This academic achievement also demonstrates the exceptional clinical research capabilities of Chinese investigators and the solid innovative R&D abilities of Innovent. With mazdutide’s imminent approval in China, we look forward to offering an advanced therapeutic option to improve the health and quality of life of individuals living with overweight or obesity. As an innovative pharmaceutical company, Innovent has actively responded to and promoted the goal of ‘Healthy China 2030’ by advancing science-based weight management through strategic collaborations and cutting-edge medical achievements. “
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