Second Phase III win sets stage for Chinese approval of Innovent’s mazdutide in diabetes
Phase 3Clinical ResultDrug Approval
Innovent Biologics on Monday said its dual GLP-1/glucagon receptor (GCGR) agonist mazdutide met the primary and key secondary endpoints of a second Phase III study, dubbed DREAMS-1, in Chinese patients with type 2 diabetes. The success comes after the DREAMS-2 study demonstrated mazdutide’s superiority over Eli Lilly’s GLP-1 receptor agonist Trulicity (dulaglutide) in May.
Backed by data from DREAMS-1 and DREAMS-2, Innovent intends to file a marketing application for mazdutide with China's National Medical Products Administration (NMPA) in the near term. Touting the drug as “the first and fastest-developed GLP-1R/GCGR dual agonist in the world,” Lei Qian, vice president of clinical development at Innovent, said “the two studies demonstrate mazdutide's comprehensive efficacy in improving glycaemic control, promoting weight loss, and enhancing metabolic outcomes in patients with [type 2 diabetes].”
Marked HbA1C reduction
DREAMS-1 randomised 320 participants with type 2 diabetes, inadequately controlled on diet and exercise alone, to receive either mazdutide 4 mg, 6 mg or placebo for 24 weeks. Results showed that both doses of Innovent’s therapy demonstrated superiority to placebo on the main goal of change in HbA1c level from baseline at 24 weeks (1.57% and 2.15% vs 0.14%, respectively).
Moreover, mazdutide beat placebo on secondary endpoints of glucose-lowering and weight loss, alongside cardiometabolic indicators such as waist circumference, blood pressure, blood lipids, liver transaminases and urine albumin-to-creatinine ratio. In terms of safety, the company noted a low incidence of hypoglycaemia events in the study, none being severe.
Innovent, which secured Chinese rights to mazdutide from Eli Lilly in 2019, is also conducting the Phase III DREAMS-3 trial pitting the drug head-on with Novo Nordisk’s GLP-1 agonist Ozempic (semaglutide). Lilly has already positioned Mounjaro (tirzepatide) in the Chinese market, after having gained approval recently. Meanwhile, a regulatory review of mazdutide for chronic weight management in adults with obesity or overweight is under way in China following its success in the GLORY-1 study.
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