Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the Phase 3 clinical study results for mazdutide, a dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, in Chinese adults with type 2 diabetes (T2D) (DREAMS-1) were orally presented (Abstract #: 306-OR) at the 85th Scientific Sessions of the American Diabetes Association (ADA), with Dr. Lei Qian from Innovent Biologics, as the presenter. The DREAMS-1 clinical study met its primary endpoint and all key secondary endpoints in July 2024. Mazdutide demonstrated dual benefits in glycemic control and weight loss, along with comprehensive improvements in cardiovascular, renal, and metabolic indicators. These findings provide important evidence-based medical support for the use of next-generation GCG/GLP-1 receptor agonists in treating T2D. In August 2024, mazdutide’s NDA for glycemic control of T2D patients was accepted by China’s National Medical Products Administration (NMPA) for review. It is expected to offer a better treatment option for Chinese T2D patients soon.
DREAMS-1 (ClinicalTrials.gov, NCT05628311) enrolled 319 Chinese participants with T2D inadequately controlled by diet and exercise alone (mean age 50.4 years, mean baseline HbA1c 8.24%, mean baseline body weight 77.7 kg). Participants were randomized to receive mazdutide 4 mg, mazdutide 6 mg or placebo for 24 weeks. The primary endpoint was the change in HbA1c from baseline to week 24.
Mazdutide demonstrated robust glucose-lowering efficacy, achieving HbA1c reduction of 2.15% after 24 weeks of treatment
For the efficacy estimand, the change in HbA1c from baseline to week 24 were -1.57% and -2.15% for mazdutide 4 mg and mazdutide 6 mg, respectively, demonstrating superiority to placebo (-0.14%). At week 24, 68.6% and 87.4% of participants receiving mazdutide 4 mg and 6 mg, respectively, achieved HbA1c <7.0% compared to 10.7% with placebo. Additionally, 55.6% and 81.5% of participants receiving mazdutide 4 mg and 6 mg, respectively, achieved HbA1c ≤6.5%, compared to 4.4% with placebo.
Mazdutide demonstrated robust efficacy in both glycemic control and weight reduction
For the efficacy estimand, after 24 weeks of treatment, the percentage change in body weight from baseline to week 24 were -5.61% and -7.81% for mazdutide 4 mg and mazdutide 6 mg, respectively, demonstrating superiority to placebo (-1.26%). At week 24, 50.9% and 69.0% of participants receiving mazdutide 4 mg and mazdutide 6 mg achieved a weight reduction of ≥5%, compared to 7.3% with placebo. Additionally, 40.6% and 64.9% of participants treated with mazdutide 4 mg and mazdutide 6 mg achieved both a weight reduction of ≥5% and HbA1c < 7.0%, respectively (vs. placebo: 0%).
Improvements in multiple cardiometabolic risk factors
Mazdutide treatment also led to significant and clinically meaningful improvements on fasting glucose, self-measured blood glucose, waist circumference, blood pressure, lipids, and transaminases.
Favorable safety profile and no new safety signals observed
- Mazdutide was well tolerated, with low incidence of TEAEs leading to treatment discontinuation.
- Gastrointestinal symptoms were the most common adverse events, mostly mild to moderate severity, transient, and occurring mainly during dose escalation.
- Low incidence of hypoglycemia, and no severe hypoglycemia was reported.
- The overall safety profile was consistent with previous clinical studies of mazdutide, with no new safety signals observed.
Mazdutide is the most advanced dual GCG/ GLP-1 receptor agonist in clinical development, with two NDAs currently under review by China’s NMPA:
(1) Chronic weight management in adults with obesity or overweight
(2) Glycemic control in adults with type 2 diabetes
Professor Lixin Guo, the Principal Investigator of DREAMS-1, Nanjing University Affiliated Drum Tower Hospital, said: “China has a high incidence of T2D, with 140 million adult patients, ranking first in the world. A significant proportion of these patients also suffer from overweight/obesity, cardiovascular diseases, and/or kidney diseases, making prevention and treatment a formidable challenge. There is an urgent need for more effective and safer innovative drugs. In recent years, GLP-1 receptor agonists have emerged as a superior treatment option for type 2 diabetes due to their comprehensive benefits in blood glucose control, weight management, and cardiovascular and renal health. Mazdutide, as a dual GCG/GLP-1 receptor agonist, demonstrated superior efficacy compared to placebo in glycemic control and weight reduction in the DREAMS-1 study in Chinese patients with T2D inadequately controlled by diet and exercise alone. It also showed a favorable safety profile. Additionally, mazdutide offers comprehensive benefits such as reduced waist circumference, blood pressure, and lipid levels. I am delighted to see the study results presented as an oral presentation at ADA congress and look forward to mazdutide’s approval in near future, providing a new treatment option for T2D patients in China and improving their clinical outcomes.”
Professor Jiajun Zhao, the Principal Investigator of DREAMS-1, Shandong Provincial Hospital, said: “In recent years, the treatment for diabetes has gradually shifted from mere blood glucose control to a ‘patient-centered’ approach, integrating glycemic control, weight management, cardiovascular risk factor management, and addressing cardiorenal comorbidities and complications. GLP-1 receptor agonists not only excel in glycemic control but also effectively reduce weight, making them a hotspot and frontier in metabolic disease drug development. The pivotal clinical study DREAMS-1 for mazdutide, a dual GCG/GLP-1 receptor agonist, was orally presented at ADA 85th Scientific Sessions, reaffirming its outstanding efficacy in glucose-lowering and weight reduction, multiple metabolic benefits, and favorable safety profile. We hope it will soon benefit Chinese patients with T2D.”
Dr. Lei Qian from Innovent Biologics said: “I am pleased to orally present the results of DREAMS-1 at this year’s ADA conference, which demonstrated its comprehensive benefits in glycemic control, weight reduction, and multiple metabolic indicators. This also reflects the outstanding research capabilities of Chinese investigators and Innovent’s solid clinical development strength. The detailed results of DREAMS-1 and another Phase 3 study (DREAMS-2), which compared mazdutide with dulaglutide combined with oral hypoglycemic drugs in Chinese T2D patients, will also be published in academic journals. We hope mazdutide will soon be approved and launched, benefiting the vast number of T2D patients in need of comprehensive improvements in blood glucose, weight, and cardiovascular metabolic indicators. Innovent will continue to develop a next-generation pipeline in the cardiovascular and metabolic fields, meeting the public’s aspirations for a healthier life and serving more patients.”
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