A weight loss of over 15 kg in one year achieved with 9 mg mazdutide in a Phase 2 study of Chinese adults with a BMI ≥ 30 kg/m2; results published in MED, a Cell Press Journal
2026-03-30 · Innovent Biologics (Suzhou) Co. Ltd. · original innoventbio.com ↗
SAN FRANCISCO, U.S., SUZHOU, China March 30, 2026 – 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, ophthalmologic and other major diseases, announces that the results of a Phase 2 clinical study of 9 mg mazdutide in Chinese patients with obesity 1 was published online in the full text of MED, a Cell Press Journal. Mazdutide is the world’s first approved glucagon (GCG)/glucagon-like peptide-1 (GLP-1) dual-receptor agonist, indicated for the treatment of type 2 diabetes and overweight/obesity. The current Phase 2 study, along with the ongoing GLORY-2 study, is designed to evaluate the efficacy and safety of a higher 9 mg dose of mazdutide in patients with obesity. The first author of this article is Professor Linong Ji from Peking University People's Hospital. Professor Linong Ji and Dr. Lei Qian from Innovent Biologics are the co-corresponding authors of this article. Overweight and obesity are associated with a range of cardiometabolic diseases, and patients have an increased risk of developing cardiometabolic diseases with increasing body mass index (BMI) 2. Overweight and obesity have become a global public health challenge. In China, the prevalence of obesity has risen rapidly in the past decades, reaching 16.4% by Chinese criterial (BMI ≥28 kg/m2) 3. When applying the World Health Organization (WHO) criteria (BMI ≥30 kg/m²), the number of obese adults in China has reached approximately 85 million 4. In this multicenter, randomized, double-blind, placebo-controlled Phase 2 trial, a total of 80 Chinese adult obese patients without diabetes were enrolled, with a mean baseline BMI of 34.3 kg/m2 and a mean weight of 96.9 kg. Participants were randomized in a 3:1 ratio to receive once-weekly subcutaneous injections of mazdutide (initiated at 3 mg once weekly and increased by 3 mg every 4 weeks until the target dose of 9 mg was reached) or placebo for 24 weeks. After the 24-week treatment, 59 participants voluntarily chose to continue a double-blind, extended 24-week treatment and maintained their original treatment group allocation and treatment regimen. The primary endpoint was the percentage change in body weight from baseline to week 24. The results indicated that the mazdutide 9 mg achieved a placebo-adjusted weight loss of 15.4% at week 24, along with improvements in cardiometabolic risk factors. At week 48, the weight loss efficacy further increased, while cardiometabolic parameters were generally maintained. Mazdutide 9 mg exhibited a manageable safety profile. In November 2025, the Phase 3 GLORY-2 study of mazdutide 9 mg met its primary endpoint and all key secondary endpoints, demonstrating a 20.1% weight loss in Chinese patients with moderate-to-severe obesity and without diabetes 5. Based on these results, the marketing application for mazdutide 9 mg for long-term weight management in adults with moderate-to-severe obesity was accepted for review by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China in November 2025. Mazdutide 9 mg is expected to offer a new treatment option for Chinese adults with moderate-to-severe obesity. Results from this Phase 2 study Mazdutide 9 mg demonstrated robust weight-reduction efficacy The study results showed that mazdutide 9 mg demonstrated a placebo-adjusted weight reduction of 15.4% at week 24. Compared with no participants in the placebo group achieving ≥ 5% weight reduction, 81.7% of participants achieved weight reduction ≥5%, 65.0% achieved weight reduction ≥10%, and 21.7% achieved weight reduction ≥20% at week 24 in the mazdutide 9 mg group. At week 48, mazdutide 9 mg achieved a placebo-adjusted weight reduction of 18.6% and the percentage of participants with weight reduction ≥20% increased to 34.9%. Mazdutide 9 mg offered multiple cardiometabolic benefits At week 24, compared with the placebo group, the mazdutide 9 mg group showed notable improvements in multiple cardiometabolic risk factors, including waist circumference, blood pressure, lipids (triglyceride, total cholesterol, and low-density lipoprotein cholesterol), and serum uric acid; these benefits were maintained at week 48. Mazdutide showed clinical meaningful liver fat lowering Among 17 participants with baseline liver fat content (LFC) ≥ 5%, at week 24, the percentage change in LFC from baseline was −73.3% in the mazdutide 9 mg group and −6.57% in the placebo group; 83.3% of participants in the mazdutide group achieved LFC <5%, while no participants in the placebo group achieved this target. Mazdutide 9 mg demonstrated a manageable safety profile Mazdutide 9 mg demonstrated good tolerability. No treatment-emergent adverse events (TEAEs) leading to treatment discontinuation were reported. No serious adverse events occurred. The overall safety profile was consistent with previous clinical studies of mazdutide, and no new safety signals were observed. The most common TEAEs were nausea (50.0% [30/60] with mazdutide vs 0% with placebo), diarrhea (38.3% [23/60] vs 10.0% [2/20]), and vomiting (36.7% [22/60] vs 10.0% [2/20]), which were mostly mild or moderate, transient, and occurred mainly during the dose titration phase. Professor Ji Linong from Peking University People's Hospital, who led the study, said that obesity and its associated cardiovascular and metabolic diseases have become major global public health challenges. In China, the prevalence of obesity has increased rapidly over the past few decades. Although several GLP-1 receptor agonists have been approved for weight management in China, the clinical evidence is still limited in the Chinese adult population with BMI ≥30 kg/m2. The mean BMI of the Chinese obese population is generally lower than that of the Western obese population, but the prevalence of abdominal obesity is more prominent. Mazdutide effectively addresses this by suppressing hepatic fat synthesis, enabling substantial weight reduction. Its robust weight-reduction efficacy and comprehensive and sustained cardiometabolic improvement effects further confirm its unique dual-target mechanism of action—simultaneous synergistic agonism of the GCG receptor while activating the GLP-1 receptor, thereby bringing more significant clinical benefits to patients. Dr. Lei Qian, Chief R&D Officer (General Biomedicine) from Innovent Biologics (Suzhou) Co., Ltd., stated “Mazdutide is the world's first approved dual-receptor agonist of GCG/GLP-1. Multiple dosage strengths of mazdutide have been developed to enable more precise and individualized treatment approaches. The marketing application for mazdutide 9 mg for long-term weight management in adults with moderate-to-severe obesity was accepted for review by the National Medical Products Administration of China. Available clinical data support the further development of mazdutide 9 mg as a promising treatment option for the Chinese population with moderate-to-severe obesity. Mazdutide 9 mg demonstrates robust weight-reduction efficacy and offers comprehensive benefits in improving multiple cardiometabolic risk factors. It is positioned as a promising non-surgical option for long‑term weight management in patients with moderate-to-severe obesity, as well as a powerful tool in addressing the serious public health challenge of obesity in China. As an innovation-driven biopharmaceutical company, Innovent Biologics actively supports national health strategies, advancing scientific weight management through cutting-edge pharmaceutical innovations, and contributing expertise to realize the ‘Healthy China’ vision.” About Mazdutide Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of GLP-1 receptor agonists—such as promoting insulin secretion, lowering blood glucose and reducing body weight. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies. It has also shown benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity. Mazdutide has been conducted in or completed a total of nine Phase 3 clinical studies, including: GLORY-1: A Phase 3 trial (mazdutide 4 mg and 6 mg) in Chinese participants with overweight or obesity. GLORY-2: A Phase 3 trial (mazdutide 9 mg) in Chinese participants with moderate-to-severe obesity. DREAMS-1: A Phase 3 trial in treatment-naïve Chinese participants with T2D. DREAMS-2: A Phase 3 trial comparing mazdutide and dulaglutide in Chinese T2D participants with inadequate glycemic control on oral antidiabetic drugs. DREAMS-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese participants with T2D and obesity. GLORY-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese participants with overweight/obesity and metabolic dysfunction-associated fatty liver disease (MAFLD). GLORY-OSA: A Phase 3 trial in Chinese participants with OSA and obesity. GLORY-ADOLESCENT: A Phase 3 trial in Chinese adolescents with obesity. GLORY-H: A Phase 3 trial in Chinese participants with obesity and hypertension. Among these, the first five phase 3 studies have met primary endpoints, and the latter four phase III trials remain ongoing. In addition, several clinical studies of mazdutide are ongoing, including studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF) and a head-to-head comparation of high-dose mazdutide versus tirzepatide for the treatment of moderate-to-severe obesity. *Mazdutide has received NMPA approval for two indications: 1. Long-term weight control in adult patients As an adjunct to dietary control and increased physical activity in adults with initial BMI: ≥28 kg/m² (obesity), or ≥24 kg/m² (overweight) plus ≥1 weight-related comorbidity (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome). 2. Glycemic control in adults with T2D: Monotherapy: Adults with inadequately controlled T2D after diet/exercise intervention alone. Combination Therapy: Adults with inadequately controlled T2D who insufficient glycemic control despite diet/exercise intervention on metformin and/or sulfonylureas, metformin and/or sodium-glucose cotransporter 2 inhibitors (SGLT2i). Mazdutide has garnered significant academic and industry recognition for its robust clinical data. Clinical results have been presented in globally renowned journals including Nature, NEJM, Nature Communications, Diabetes Care, and eClinicalMedicine. Mazdutide is the first China-developed innovative drug with two clinical studies simultaneously published in Nature and the only GLP-1-based therapy ever to achieve top-tier publications in both Nature and NEJM. It has now been included in multiple Chinese expert consensus guidelines for obesity and type 2 diabetes management. Previously, mazdutide was named to FIERCE Pharma's "Top 10 Most Anticipated Innovative Drugs of 2025", and Its phase 2 clinical trial in Chinese overweight/obese participants was selected by Nature Communications as one of the "50 Most Significant Translational Medicine Studies" and featured as an Editor's Highlight. About Innovent 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 18 products in the market. It has 5 assets in Phase III or pivotal clinical trials and 14 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. For more information, please contact: Media: Email: [email protected] Tel.: +86 512-69566088 Investor: Email: [email protected] Tel.: +86 512-69566088 References Ji, L. et al. Mazdutide 9 mg in Chinese adults with a body mass index ≥30 kg/m2 but without diabetes: A phase 2 randomized controlled trial. Med 101063 (2026) doi:10.1016/j.medj.2026.101063. Lingvay, I., Cohen, R. V., le Roux, C. W. & Sumithran, P. Obesity in adults. The Lancet 404, 972–987 (2024). Pan, X.-F., Wang, L. & Pan, A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 9, 373–392 (2021). Wang, L. et al. Body-mass index and obesity in urban and rural China: findings from consecutive nationally representative surveys during 2004–18. The Lancet 398, 53–63 (2021). https://www.innoventbio.com/#/news/656.
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