2026ADA | Innovent Biologics Presents Results of DREAMS-3: the First Globally Approved GCG/GLP-1 Dual Receptor Agonist versus Semaglutide in a Head-to-Head Phase 3 Randomized Controlled Trial
2026-06-08 · Innovent Biologics (Suzhou) Co. Ltd. · original innoventbio.com ↗
SAN FRANCISCO and SUZHOU, China, June 8, 2026 -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that key results from the Phase III DREAMS-3 trial of mazdutide, the world’s first approved glucagon (GCG)/glucagon-like peptide-1 (GLP-1) dual receptor agonist versus semaglutide in Chinese adults with type 2 diabetes (T2D) and comorbid obesity, were presented as an oral presentation (1226-OR) at the 2026 American Diabetes Association (ADA) Scientific Sessions. DREAMS-3 is a randomized, head-to-head trial comparing a GCG/GLP-1 dual receptor agonist of mazdutide with a GLP-1 receptor agonist of semaglutide. Mazdutide 6 mg demonstrated superior efficacy in both glycemic control and weight reduction. After 32-weeks of treatment, the percentage of participants achieving both HbA1c <7.0% and ≥10% weight loss was 48.0% in the mazdutide 6 mg group, significantly higher than 21.0% in the semaglutide 1 mg group; mean HbA1c reduction from baseline was −2.03% with mazdutide 6 mg, significantly greater than −1.84% with semaglutide 1 mg. Mazdutide demonstrated superior glycemic control and weight reduction versus semaglutide This multicenter, randomized, open-label Phase 3 DREAMS-3 (NCT06184568) trial enrolled 329 Chinese participants with T2D and comorbid obesity, who had inadequate glycemic and weight control with diet/exercise alone or metformin monotherapy. Baseline characteristics: mean age 42.4 years, mean HbA1c 8.02%, mean diabetes duration 1.8 years, mean body weight 90.5 kg, mean BMI 33.0 kg/m². Participants were randomized 1:1 to receive mazdutide (or semaglutide for 32 weeks (including 8 weeks for dose escalation; starting from 2 mg to the target dose 6 mg for mazdutide and 0.25 mg to 1 mg for semaglutide). After 32 weeks, participants in the semaglutide 1 mg group entered a 4-week follow-up period and completed the trial, while those in the mazdutide 6 mg group were scheduled to continue for a 24-week extension period on mazdutide 6 mg or 9 mg based on weight response and tolerability. Primary endpoint was the percentage of participants achieving both HbA1c <7.0% and ≥10% weight loss at week 32. Dual glycemic and weight target achievement rate more than doubled vs. semaglutide This phase 3 DREAMS-3 study met the primary endpoint. Under the efficacy estimand, the percentage of participants achieving both HbA1c <7.0% and ≥10% weight loss at week 32 was significantly superior with mazdutide 6 mg vs. semaglutide 1 mg―more than doubling the rate of semaglutide (48.0% vs. 21.0%, p<0.0001). Mazdutide also demonstrated significantly higher achievement rates for other dual-component endpoints vs. semaglutide (p<0.0001 for all comparisons): HbA1c <7.0% and ≥5% weight loss: 74.7% vs. 51.0% HbA1c <6.5% and ≥5% weight loss: 69.4% vs. 48.7% HbA1c <6.5% and ≥10% weight loss: 45.7% vs. 20.8% Mazdutide led to a HbA1c reduction of 2.03% Under the efficacy estimand, mean change in HbA1c from baseline at week 32 was ─2.03% with mazdutide 6 mg vs. ─1.84% with semaglutide 1 mg (p<0.05). Mazdutide achieved higher rates of HbA1c targets (<7.0%, <6.5%, and <5.7%) versus semaglutide. Mazdutide showed a weight loss of 10.3% Under the efficacy estimand, mean change in body weight from baseline at week 32 was ─10.3% with mazdutide 6 mg vs. -6.0% with semaglutide 1 mg (p<0.0001). More participants in the mazdutide 6 mg group achieved ≥5% (80.6% vs. 52.8%) and ≥10% weight loss (51.2% vs. 21.3%) vs. semaglutide 1 mg (both p<0.0001). Mazdutide offered broad metabolic benefits Mazdutide led to clinically meaningful improvements in waist circumference, fasting blood glucose, blood pressure, and lipid profiles. Mazdutide 6 mg demonstrated a manageable safety profile Mazdutide 6 mg was well tolerated, with a low incidence of adverse events leading to treatment discontinuation. Gastrointestinal disorders were the most common adverse events (nausea [mazdutide 6 mg: 30.5%; semaglutide 1 mg: 12.6%], diarrhea [27.0%; 21.8%], and vomiting [23.6%; 8.6%]), generally mild to moderate, transient, and occurring mainly during the dose-escalation phase. The incidence of hypoglycemia was low, with no severe hypoglycemia reported. The overall safety profile was consistent with previous mazdutide trials, with no new safety signals identified. An innovative treatment option for 70 million patients with diabesity T2D with comorbid obesity—termed diabesity—has reached epidemic proportions globally and represents a major public health challenge. In China, the burden is particularly severe: 70 million adults with T2D are also overweight or obese. Persistent hyperglycemia and uncontrolled weight gain not only impair quality of life and impose a long-term physical burden but also significantly increase the risk of cardiovascular, renal, retinal, and other complications. Regarding this issue, Professor Linong Ji from Peking University People’s Hospital, who led the study, stated: “The global prevalence of T2D with obesity (diabesity) continues to rise, posing a critical public health challenge. In China, over half of individuals with T2D are overweight or obese, and poor glycemic and weight control substantially reduces quality of life and shortens life expectancy. This head-to-head Phase 3 DREAMS-3 study demonstrates that mazdutide delivered superior glycemic and weight loss efficacy in patients with T2D and obesity compared with semaglutide, alongside significant improvements in cardiometabolic risk factors. Mazdutide is well tolerated, with manageable gastrointestinal events. In summary, mazdutide offers a treatment option for integrated glycemic, weight, and metabolic management in people with diabesity. As the only globally approved GCG/GLP-1 dual receptor agonist for both T2D and weight management, its clinical value carries profound practical significance for China’s large diabesity population.” As an effective therapy for glycemic control and weight reduction, mazdutide acts via the GLP-1 pathway to stabilize blood glucose and suppress appetite, while targeting the GCG pathway to directly act on the liver, promote fat oxidation and boost metabolism. It reduces body weight and visceral fat, and improves systemic metabolism. Key clinical findings for mazdutide have been published in top-tier international journals, including Nature, The New England Journal of Medicine (NEJM), and JAMA. It is also the only GLP-1 drug globally whose clinical outcomes have been published in all three top science or medicine journals. Dr. Lei Qian, Chief R&D Officer (General Biomedicine), Innovent, stated: “China has a large population with T2D and obesity, with high rates of comorbidities. Therefore, there is an urgent need for more effective, safer, and convenient innovative therapies. Mazdutide is the only globally approved GCG/GLP-1 dual receptor agonist for both T2D and weight management. Previous DREAMS-1 and DREAMS-2 studies established its comprehensive benefits in glycemic control, weight loss, and metabolic parameters. This head-to-head DREAMS-3 study further demonstrates that mazdutide achieves superior weight loss and glycemic outcomes versus semaglutide in patients with T2D and obesity. With ongoing approvals, mazdutide will benefit a broader population with metabolic diseases, supporting comprehensive improvements in glycemic control, body weight, and cardiometabolic health. As an innovative Chinese biopharmaceutical company, Innovent remains guided by the Healthy China 2030 strategy, safeguarding national metabolic health through cutting-edge pharmaceutical innovation and contributing to a healthier China.” 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-YOUNG: 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: 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). 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, JAMA,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 1 asset under NMPA review, 4 assets in phase 3 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, Pfizer, 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: 1.Innovent does not recommend the use of any unapproved drug or unapproved indication. 2.This article is intended for scientific and educational purposes only and should not be construed as a recommendation or suggestion for any treatment or drug. If you feel unwell, please be sure to follow your physician's advice for medication and treatment. 3.Ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), and pirtobrutinib tablets (Jaypirca®) were developed by Eli Lilly and Company. 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. Reference Guo, L. et al. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. Nature 652, 181–188 (2026). Zhu, D. et al. Mazdutide versus placebo in Chinese adults with type 2 diabetes. Nature 652, 174–180 (2026). Ji, Q. et al. Prevalence and co-prevalence of comorbidities among Chinese adult patients with type 2 diabetes mellitus: a cross-sectional, multicenter, retrospective, observational study based on 3B study database. Front. Endocrinol. 15, 1362433 (2024).
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