Head-to-head Superiority over Dulaglutide: Innovent's Phase 3 Clinical Trial DREAMS-2 of Mazdutide in Chinese Patients with Type 2 Diabetes were Orally Presented at EASD 2024
Meanwhile, the first Phase 3 study results of mazdutide in the weight loss of overweight/obese subjects (GLORY-1) were reported in oral presentation session of EASD. Mazdutide also works as a breakthrough weight-loss drug that offers dual-targeted fat burning, liver function improvement, and long-lasting weight reduction, providing comprehensive metabolic benefits to support weight loss and promote a healthier life.
DREAMS-2 (ClinicalTrials.gov, NCT05606913) enrolled 731 Chinese participants with T2D (mean age 51.8 years, mean baseline HbA1c 8.22%, mean baseline body weight 76.95 kg), whose diabetes was inadequately controlled with metformin alone or in combination with other oral anti-diabetic medications. Participants were randomized to receive mazdutide 4 mg, mazdutide 6 mg or dulaglutide 1.5 mg for 28 weeks. The primary endpoint was the change in HbA1c from baseline to week 28.
Superiority of mazdutide to dulaglutide in glycemic control*
For the efficacy estimand, after 28 weeks of treatment, mean reductions in HbA1c from baseline were 1.69% and 1.73% for mazdutide 4 mg and mazdutide 6 mg, respectively, demonstrating superiority over dulaglutide 1.5 mg (1.36%). At week 28, 71.2% and 74.2% of participants receiving mazdutide 4 mg and 6 mg, respectively, achieved HbA1c <7.0% compared to 62.1% with dulaglutide. Additionally, 54.8% and 63.1% of participants receiving mazdutide 4 mg and 6 mg, respectively, achieved HbA1c ≤6.5% , compared to 42.1% for dulaglutide.
Mazdutide's superiority over dulaglutide in weight loss and HbA1c/weight composite endpoints*
After 28 weeks of treatment, participants treated with mazdutide 4 mg and mazdutide 6 mg experienced mean weight reductions of 9.24% and 7.13%, respectively, significantly outperforming dulaglutide (2.86%). At week 28, 62.4% and 78.2% of participants receiving mazdutide 4 mg and mazdutide 6 mg achieved a weight reduction of ≥5%, compared to 26.9% for dulaglutide. Additionally, 50.1% and 64.3% of participants with mazdutide 4 mg and mazdutide 6 mg achieved both a weight reduction of ≥5% and HbA1c < 7.0%, respectively (dulaglutide 19.4%).
Improvements on multiple cardiometabolic risk factors by mazdutide
Mazdutide treatment also led to significant and clinically meaningful improvements on fasting glucose, post-prandial glucose, waist circumference, blood pressure, lipids, serum uric acid and transaminases, mostly greater than dulaglutide. Detailed results will be published in peer-reviewed journals.
Favorable safety and tolerability profile and no new safety signals
- Mazdutide was well tolerated, with low incidence of TEAEs leading to treatment discontinuation.
- The overall safety profile was consistent with previous clinical studies of mazdutide, with no new safety signals observed. Gastrointestinal symptoms were the most common adverse events, mostly mild to moderate in severity, transient, and occurring mainly during dose escalation. No severe hypoglycemia was reported with mazdutide, and the incidence of grade 1-2 hypoglycemia was comparable to dulaglutide.
Mazdutide is the first GLP-1R/GCGR dual agonist in the regulatory review status, with a first new drug application (NDA) for chronic weight management and a second NDA for T2D currently under review by the
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About Diabetes
According to the 2021 global diabetes overview by the
About Mazdutide (IBI362)
Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in
Mazdutide has two NDAs accepted by
- For the chronic weight management in adults with obesity or overweight;
- For the glycemic control in adults with type 2 diabetes.
Currently, a total of five Phase 3 studies of mazdutide are underway, including:
- Phase 3 study conducted in Chinese adults with overweight or obesity (GLORY-1);
- Phase 3 study conducted in Chinese adults with moderate to severe obesity (GLORY-2);
- Phase 3 study in newly treated Chinese patients with type 2 diabetes (DREAMS-1);
- Phase 3 study comparing mazdutide and dulaglutide in Chinese patients with type 2 diabetes (DREAMS-2);
- Phase 3 study comparing mazdutide and semaglutide in Chinese patients with type 2 diabetes and obesity (DREAMS-3).
Among them, GLORY-1, DREAMS-1 and DREAMS-2 have reached the study endpoints.
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 11 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte,
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).
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References:
[1]. Sun H, Saeedi P, Karuranga S, et al. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projects for 2045 [published correction appeals in Diabetes Res Clin Pract. 2023 Oct; 204: 110945]. Diabetes Res Clin Pract. 2022; 183: 109119. doi: 10.1016/j.diabres.2021. 109119 [2]. Gregg EW, Sattar N, Ali MK. The changing face of diabetes complications. Lancet Diabetes Endocrinol. Published online 2016. doi: 10.1016/S2213-8587 (16) 30010-9
[3]. Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes-state-of-the-art. Mol Metab. Published online 2020. doi: 10.1016/j.molmet.2020. 101102 |
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