Innovent Biologics has lifted the curtain on late-stage data from its next-generation “double-G” drug in overweight or obese Chinese patients after the company teased in January that the trial delivered positive results.
The Suzhou-based biotech licensed the China rights to the dual GLP-1/glucagon receptor agonist, dubbed mazdutide, from Eli Lilly in a 2019 deal with undisclosed financials. Mazdutide is currently under review with China’s National Medical Products Administration for weight management.
In the 610-participant Phase 3 GLORY-1 trial, 6 mg mazdutide achieved a mean 12.55% weight loss at 32 weeks versus 0.45% for placebo. Further, 82% of subjects given the same dose reached at least 5% weight loss at 32 weeks versus 10.5% with placebo, according to an abstract from the American Diabetes Association’s annual conference.
By comparison, Boehringer Ingelheim and Zealand Pharma’s survodutide, which is also a dual agonist of the same targets, achieved almost 19% weight loss at 46 weeks in overweight and obese participants in a 387-participant Phase 2 test. The drug candidate is currently in a trio of Phase 3 studies in overweight and obese people.
In the ADA abstract, mazdutide improved several cardiometabolic markers including blood pressure, triglyceride levels and cholesterol levels at 48 weeks, according to secondary endpoint data. The most common side effects were gastrointestinal in nature and mostly mild to moderate in severity.
The candidate also helped improve liver steatosis in GLORY-1 patients, according to an exploratory analysis.
The Suzhou-based biotech is preparing to launch mazdutide for weight loss in China in the first half of 2025, Jefferies analysts said in March. Innovent is also testing a 9 mg dose of mazdutide in the 450-participant Phase 3 GLORY-2 trial in Chinese people with obesity. The first participant was dosed in January.
Last month, the biotech touted data from the Phase 3 DREAMS-2 trial showing mazdutide was “superior compared with dulaglutide” — the active ingredient in Eli Lilly’s Trulicity — in Chinese patients with diabetes.
Innovent is also planning to file mazdutide with the NMPA for type 2 diabetes pending data from a 319-participant Phase 3 test, dubbed DREAMS-1. The trial is set to complete in January next year, according to ClinicalTrials.gov.
Mazdutide is forecast to reach $327 million in annual global sales by 2039, GlobalData analysts said earlier this month.