SAN FRANCISCO and SUZHOU, China, Nov. 19, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, and ophthalmologic diseases, announces that the Phase 3 clinical trial of mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, in Chinese adults with obesity (GLORY-2) met the primary endpoints and all key secondary endpoints. Innovent plans to submit the new drug application (NDA) of mazdutide 9 mg for weight management to the Center for Drug Evaluation (CDE) of China'sNational Medical Products Administration (NMPA) in the near term.

GLORY-2 (NCT06164873) is a Phase 3 clinical study to evaluate the efficacy and safety of mazdutide 9 mg combined with lifestyle intervention versus placebo in Chinese adults with obesity (BMI ≥30 kg/m²). The study enrolled 462 participants (including 16% with type 2 diabetes), randomized in a 2:1 ratio to receive mazdutide 9 mg group or placebo in the 60-week double-blind treatment period (mean baseline weight: 94.0 kg; mean BMI: 34.3 kg/m²).

During the treatment period, participants in the mazdutide group exhibited continuous weight loss, with no plateau observed in Week 60. At Week 60, the mazdutide 9 mg group achieved a mean weight reduction of 18.55%, compared to 3.02% in the placebo group. 44.0% of participants in the mazdutide 9 mg group achieved a weight reduction of 20% or more, versus 2.6% in the placebo group (P<0.0001 for all comparisons). The key secondary endpoints demonstrated that among participants without type 2 diabetes, the mazdutide 9 mg group showed a mean weight reduction of 20.08% at Week 60 (placebo: 2.81%), with 48.7% of participants achieving a weight reduction of 20% or more (placebo: 3.1%; P<0.0001).

Furthermore, all key secondary endpoints of the study were met, including other body weight endpoints, waist circumference, systolic blood pressure, triglycerides, non-HDL cholesterol, LDL cholesterol, and serum uric acid levels. Mazdutide 9 mg demonstrated superiority to placebo in all the above weight-loss and cardiometabolic endpoints.

This study also evaluated liver fat content using MRI-PDFF in a subset of participants. Among participants (without type 2 diabetes) with baseline liver fat content ≥10%, the mean percent change in liver fat content from baseline to week 60 was -71.9% in the mazdutide 9 mg group compared with 5.1% in the placebo group.

Mazdutide 9 mg demonstrated favorable tolerability and safety profiles, with no new safety signals identified. The majority of gastrointestinal adverse events were mild to moderate in severity and transient in nature. The proportion of participants who discontinued treatment prematurely due to adverse events was 2.9% in the mazdutide 9 mg group and 0% in the placebo group.

Professor Linong Ji, the leading principal investigator of the study, Peking University People's Hospital, stated, "As a chronic disease with a complex etiology, obesity requires public awareness of long-term treatment and management. China faces a high prevalence of obesity, with obese individuals bearing a significant burden of cardiometabolic diseases. Those with a BMI exceeding 32.5 kg/m², often experience an even greater cardiometabolic burden. This patient population requires special attention in clinical weight management and metabolic syndrome prevention. According to current Chinese clinical guidelines, metabolic surgery is often considered a first-line treatment for such patients. Extensive clinical evidence on GLP-1 receptor agonists demonstrates that the weight-loss efficacy of these drugs is dose-dependent. Therefore, developing pharmacological treatments tailored to moderate-to-severe obesity could offer new therapeutic options for this group. The investigators of this study and I are delighted that this study met both its primary endpoints and all key secondary endpoints. Mazdutide 9 mg has once again demonstrated outstanding weight-loss efficacy, multiple metabolic benefits and favorable safety. We hope mazdutide 9 mg will successfully achieve regulatory approval, supporting stratified weight management for China's obese population and enabling more personalized treatment approaches."

Dr. Lei Qian, Chief R&D Officer of General Biomedicine of Innovent, stated, "Mazdutide 9 mg is currently the only GLP-1 receptor agonist that achieves over 20% weight loss in obese adults without T2D after 1 year of treatment with just a 2-step dose titration. Its development provides evidence-based medical support for effective weight management in Chinese patients with moderate-to-severe obesity, offering an alternative to metabolic surgery. We plan to submit a supplemental application for mazdutide 9 mg in the near future, aiming to deliver this innovative treatment to patients as soon as possible. Concurrently, the lifecycle management plan for mazdutide continues to expand its boundaries, exploring further therapeutic potentials. We are developing mazdutide for other indications on the basis of scientific evidence and unmet medical needs. Innovent will continue to strategically build our next-generation product pipeline in the cardiovascular and metabolic (CVM) field, and help people's pursuit of a healthy life."

Mazdutide has earned widespread recognition supported by robust data set. Its Phase 2 clinical trial in Chinese subjects with overweight or obesity was selected by Nature Communications as one of the 50 most important studies in translational and clinical research and highlighted as Editor's Choice. Additionally, mazdutide was listed among the "Top 10 Most Anticipated Drug Launches of 2025" by the FIERCE Pharma.

Furthermore, clinical findings on mazdutide have been featured in top-tier international journals such as The New England Journal of Medicine, Nature Communications, Diabetes Care, and eClinicalMedicine, as well as presented at leading scientific conferences including the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) annual meetings. Notably, mazdutide is the first innovative drug in China's endocrinology and metabolism field to have clinical results published in The New England Journal of Medicine, underscoring its significant clinical value.

About Mazdutide

Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of mazdutide, a dual GCG/GLP-1 receptor agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, in addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes, liver fat content and improved insulin sensitivity.

Innovent has currently conducted or completed seven Phase 3 clinical studies of mazdutide, including:

• GLORY-1: A Phase 3 clinical study conducted in Chinese adults with overweight of obesity;
• GLORY-2: A Phase 3 clinical study conducted in Chinese adults with moderately to severely obesity;
• DREAMS-1: A Phase 3 clinical study conducted in Chinese adults with untreated type 2 diabetes;
• DREAMS-2: A Phase 3 clinical study comparing mazdutide versus dulaglutide in Chinese adults with type 2 diabetes who have poor glycemia control with oral medication;
• DREAMS-3: A Phase 3 clinical study comparing mazdutide versus semaglutide in Chinese adults with type 2 diabetes and obesity;
• GLORY-3: A Phase 3 clinical study comparing mazdutide versus semaglutide 2.4mg in Chinese adults with overweight of obesity accompanied metabolic-associated fatty liver disease (MAFLD);
• GLORY-OSA: A Phase 3 trial in Chinese participants with obstructive sleep apnea (OSA) and obesity;

Among these, the first five Phase 3 clinical studies have all met their primary endpoints, while the remaining two Phase 3 studies are still ongoing.

In addition, several clinical studies of mazdutide are ongoing in adolescents with obesity, patients with metabolic dysfunction-associated steatohepatitis (MASH),heart failure with preserved ejection fraction (HFpEF) etc.

Mazdutide has received NMPA approval for two indications:

First Indication: As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial Body Mass Index (BMI) of:

• BMI ≥ 28 kg/m² (obesity); or
• BMI ≥ 24 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, or obstructive sleep apnea syndrome).

Second Indication: For glycemic control in adults with type 2 diabetes.

Monotherapy:

For adults with type 2 diabetes who have inadequate glycemic control despite diet and exercise interventions.

Combination Therapy:

For adults with T2D who still have poor glycemic control despite:

• Diet and exercise, plus Metformin and/or sulfonylureas;
• Diet and exercise, plus Metformin and/or SGLT2 inhibitors (SGLT2i).

About Innovent Biologics

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).

Forward-looking statement

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

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