Innovent Biologics will present pivotal Phase 3 clinical trial results for its dual receptor agonist mazdutide at the American Diabetes Association's 85th Scientific Sessions in Chicago from June 20-23, 2025. The company will deliver an oral presentation of the DREAMS-1 study, marking the first Phase 3 trial of mazdutide in Chinese adults with type 2 diabetes.
DREAMS-1 Phase 3 Trial Takes Center Stage
The DREAMS-1 trial, evaluating mazdutide versus placebo as monotherapy in treatment-naïve Chinese participants with type 2 diabetes, represents a significant milestone for the dual GLP-1R/GCGR agonist. Dr. Lei Qian, Vice President of Clinical Development at Innovent, will present the results on June 23, highlighting what the company describes as mazdutide's "differentiated profile as a next-generation GCG/GLP-1 dual receptor agonist."
According to Dr. Qian, "We are honored to orally present the results of mazdutide's first Phase 3 clinical trial in T2D (DREAMS-1) at the ADA Scientific Sessions. The growing body of medical evidence will further validate mazdutide's differentiated profile as a next-generation GCG/GLP-1 dual receptor agonist, in particularly in liver fat and serum urine reduction."
Comprehensive Mechanism of Action Studies
Beyond the pivotal DREAMS-1 results, Innovent will showcase multiple exploratory studies examining mazdutide's mechanism of action through poster presentations. These include comparative studies against semaglutide in liver fat accumulation, effects on MASH fibrosis targeting the liver-gut axis and microbiome, and hyperuricemia reduction through modulation of energy and lipid metabolism.
The presentations will feature collaborations with leading Chinese medical institutions, including Peking University Third Hospital, Zhongda Hospital Affiliated to Southeast University, and The First Affiliated Hospital of Henan University of Science and Technology.
Dual Receptor Mechanism Offers Expanded Benefits
As a mammalian oxyntomodulin analogue, mazdutide functions as both a GLP-1R and GCGR dual agonist, potentially offering advantages beyond traditional GLP-1 receptor agonists. The drug activates glucagon receptors to increase energy expenditure and improve hepatic fat metabolism while maintaining the established benefits of GLP-1 receptor activation, including insulin secretion promotion, blood glucose lowering, and body weight reduction.
Clinical studies have demonstrated that mazdutide produces excellent weight loss and glucose-lowering effects while also showing benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity.
Regulatory Progress and Clinical Pipeline
Mazdutide currently has two New Drug Applications accepted for review by China's National Medical Products Administration (NMPA), covering long-term weight management in adults with obesity or overweight and glycemic control in adults with type 2 diabetes.
The drug is being evaluated across six Phase 3 clinical studies, with GLORY-1, DREAMS-1, and DREAMS-2 having already met their primary endpoints. The comprehensive clinical program includes:
- GLORY trials: Evaluating weight management in Chinese participants with varying degrees of obesity, including a head-to-head comparison with semaglutide in patients with metabolic dysfunction-associated fatty liver disease
- DREAMS trials: Assessing glycemic control in type 2 diabetes, including comparisons with dulaglutide and semaglutide
Novel Pipeline Asset IBI3030
Innovent will also present preclinical data for IBI3030, a novel antibody-peptide conjugate targeting PCSK9, GLP-1R, GCGR, and GIPR that has shown improvements in cardiovascular risk markers. This represents the company's continued innovation in cardiovascular and metabolic disease therapeutics.
Strategic Partnership with Eli Lilly
Mazdutide's development stems from an exclusive license agreement between Innovent and Eli Lilly and Company for the development and potential commercialization of OXM3 (mazdutide) in China. This partnership reflects the strategic importance of the Chinese market for next-generation metabolic therapies.
The company has outlined plans for additional clinical studies, including a Phase 3 trial in adolescents with obesity and new studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF), indicating the broad therapeutic potential of this dual receptor approach.
