Innovent Biologics hits 20% weight loss in Phase 3: Will mazdutide become China’s Ozempic?

Mazdutide 9 mg, a dual GCG and GLP-1 receptor agonist developed by Innovent Biologics (HKEX: 01801), has demonstrated significant weight loss efficacy in a pivotal Phase 3 trial involving Chinese adults with obesity. The GLORY-2 clinical study met both its primary and all key secondary endpoints, including a mean weight loss of over 20.08 percent in non-diabetic participants. Based on these results, Innovent Biologics announced plans to file a new drug application with the Center for Drug Evaluation under the National Medical Products Administration of China for chronic weight management.

The GLORY-2 study enrolled 462 participants with a body mass index of 30 kg/m² or greater, with 16 percent of them diagnosed with type 2 diabetes. Participants were randomized in a 2:1 ratio to receive either mazdutide 9 mg or placebo over a 60-week treatment period. The average baseline weight was 94 kilograms, and the mean body mass index was 34.3 kg/m². During the course of treatment, patients in the mazdutide arm experienced consistent weight loss with no plateau by the 60-week endpoint. At the conclusion of the study, the treatment group achieved an average reduction of 18.55 percent in body weight, while the placebo group saw only a 3.02 percent reduction. Among patients without type 2 diabetes, the mazdutide 9 mg group showed a higher average weight loss of 20.08 percent. In this subgroup, 48.7 percent of participants lost 20 percent or more of their baseline weight, compared to just 3.1 percent in the placebo arm.

What cardiometabolic benefits were observed beyond weight loss with mazdutide 9 mg?

These findings reinforce the growing scientific consensus that dual agonist therapies such as mazdutide may offer a clinically effective, non-surgical alternative for patients with moderate-to-severe obesity. In addition to weight loss, the trial recorded statistically significant improvements in waist circumference, systolic blood pressure, triglycerides, LDL cholesterol, non-HDL cholesterol, and serum uric acid levels. In a subset of participants without type 2 diabetes and with baseline liver fat content of 10 percent or higher, the average reduction in liver fat content was 71.9 percent compared to a 5.1 percent increase in the placebo group.

How safe and well-tolerated was mazdutide in the 60-week obesity treatment study?

Innovent Biologics stated that the tolerability and safety profiles of mazdutide 9 mg were favorable. No new safety signals were observed, and the majority of gastrointestinal adverse events were mild to moderate and transient. The treatment discontinuation rate due to adverse events was low, at 2.9 percent for the mazdutide group and zero percent in the placebo group.

Why are Chinese obesity guidelines making room for advanced GLP-1 therapies?

Principal investigator Professor Linong Ji of Peking University People’s Hospital noted that patients in China with a body mass index over 32.5 kg/m² face increased cardiometabolic risks and are often considered candidates for metabolic surgery under current clinical guidelines. He added that pharmacological interventions such as mazdutide could serve as a viable alternative for long-term weight management in this high-risk group. According to Professor Ji, the weight-loss efficacy of GLP-1 receptor agonists is dose-dependent, and the results of the GLORY-2 study confirm that mazdutide 9 mg delivers substantial metabolic benefits alongside weight reduction. He expressed optimism that the drug would secure regulatory approval and support more personalized treatment protocols for China’s obese population.

What strategic roadmap is Innovent Biologics pursuing with mazdutide lifecycle management?

Dr. Lei Qian, Chief Research and Development Officer of General Biomedicine at Innovent Biologics, described mazdutide 9 mg as the only GLP-1 receptor agonist to demonstrate over 20 percent weight loss after one year in obese adults without type 2 diabetes using only a two-step dose titration. Dr. Qian said the company plans to submit a supplemental application in the near future and emphasized that the product could serve as an alternative to bariatric surgery. He also highlighted that Innovent Biologics is continuing to develop additional indications for mazdutide in areas of unmet need, including liver-related metabolic disorders and cardiovascular risk management.

How does mazdutide compare with global GLP-1 and dual agonist benchmarks?

Mazdutide’s clinical profile has attracted recognition in both academic and industry circles. A Phase 2 study in Chinese patients with overweight or obesity was selected by Nature Communications as one of the 50 most important studies in translational and clinical research. That study was also designated as Editor’s Choice. The drug was listed by FIERCE Pharma among the top 10 most anticipated drug launches of 2025.

Further reinforcing its visibility, mazdutide’s clinical findings have been published in leading peer-reviewed journals including The New England Journal of Medicine, Nature Communications, Diabetes Care, and eClinicalMedicine. The drug has also been featured at major international medical conferences, such as the American Diabetes Association and the European Association for the Study of Diabetes annual meetings. According to Innovent Biologics, mazdutide is the first Chinese-developed endocrinology drug to have its clinical outcomes published in The New England Journal of Medicine, underscoring its scientific and regulatory significance.

What is the scientific mechanism behind mazdutide’s dual GCG/GLP-1 receptor activity?

Mazdutide is a dual glucagon and GLP-1 receptor agonist licensed by Innovent Biologics from Eli Lilly and Company for development and potential commercialization in China. As a mammalian oxyntomodulin analogue, the drug promotes weight loss by combining the insulin secretion and appetite suppression benefits of GLP-1 activation with increased energy expenditure and hepatic fat metabolism through glucagon receptor activity. Clinical studies have demonstrated that mazdutide not only reduces body weight and improves glycemic control, but also lowers blood lipids, serum uric acid, liver enzyme levels, and improves insulin sensitivity.

How many Phase 3 trials support Innovent Biologics’ clinical development of mazdutide?

Innovent Biologics has completed or is currently conducting seven Phase 3 clinical trials of mazdutide. These include GLORY-1 in overweight or obese adults, GLORY-2 in moderate-to-severe obesity, DREAMS-1 in untreated type 2 diabetes, DREAMS-2 in patients with poor glycemic control on oral medications, and DREAMS-3 in a head-to-head comparison with semaglutide. Two additional studies, GLORY-3 and GLORY-OSA, are ongoing and target patients with metabolic-associated fatty liver disease and obstructive sleep apnea, respectively. Among these trials, five have already met their primary endpoints.

What regulatory approvals and indications has mazdutide secured in China to date?

Beyond adult obesity and type 2 diabetes, Innovent Biologics is evaluating mazdutide in adolescents with obesity and in patients with heart failure with preserved ejection fraction. The drug is already approved in China for two indications. First, for chronic weight management in adults with a body mass index of 28 kg/m² or higher, or a body mass index of 24 kg/m² with comorbid conditions such as dyslipidemia or fatty liver. Second, as monotherapy or combination therapy for glycemic control in patients with type 2 diabetes.

What should investors track next in the regulatory and commercialization timeline?

Mazdutide is a flagship asset in Innovent Biologics’ cardiovascular and metabolic pipeline, which is one of four core therapeutic areas for the company. Founded in 2011, Innovent Biologics has launched 16 commercial products and maintains partnerships with major global pharmaceutical players, including Eli Lilly and Company, Roche, Takeda, Sanofi, Incyte, LG Chem, and the MD Anderson Cancer Center. The company has two drugs under regulatory review, four candidates in Phase 3 or pivotal trials, and 15 early-stage assets in clinical development.

Analysts tracking the Chinese biopharmaceutical sector expect the GLORY-2 results to accelerate regulatory review and increase the likelihood of market approval for mazdutide 9 mg by late 2026. With rising obesity rates and a growing need for effective pharmacologic alternatives to surgery, China’s weight-loss treatment market is projected to expand significantly in the coming years. If approved, mazdutide could become a leading therapy within this space and help Innovent Biologics strengthen its competitive position both domestically and across international obesity care markets.

Sentiment among institutional investors remains cautiously optimistic as Innovent Biologics continues to invest in lifecycle extensions and real-world evidence generation. Investors are also watching closely for updates on regional partnerships, reimbursement decisions, and long-term cardiovascular outcomes associated with mazdutide. The next wave of data readouts, including from GLORY-OSA and GLORY-3, are expected to further inform the company’s strategy and regulatory engagements.

What are the key takeaways from Innovent Biologics’ Phase 3 GLORY-2 trial of mazdutide 9 mg?

• Mazdutide 9 mg achieved mean weight loss of 18.55% in the full study group and 20.08% in non-diabetic participants over 60 weeks.

• 48.7% of non-diabetic patients lost 20% or more of their body weight, compared to 3.1% in the placebo group.

• GLORY-2 met all primary and key secondary endpoints, including improvements in waist circumference, blood pressure, cholesterol, and liver fat.

• MRI data showed 71.9% liver fat reduction in a non-diabetic subgroup versus a 5.1% increase in the placebo group.

• Safety profile was favorable, with low discontinuation (2.9%) and no new safety signals reported.

• Innovent Biologics plans to file a new drug application with the NMPA for chronic weight management in China.

• Mazdutide is currently the only GLP-1 receptor agonist in China to deliver >20% weight loss in obese adults without type 2 diabetes.

• The drug has been published in The New England Journal of Medicine, selected by Nature Communications, and ranked by FIERCE Pharma among the Top 10 Most Anticipated Drug Launches of 2025.

• Innovent Biologics is advancing seven Phase 3 trials of mazdutide, with five having already met primary endpoints.

• Analysts expect regulatory approval by late 2026, with high interest in the drug’s potential to disrupt China’s obesity and metabolic care market.