Six hundred and ten people, 48 weeks, one placebo group. That is the skeleton of GLORY-1, the Phase III trial in which Innovent Biologics said in January 2024 that its weight-loss drug mazdutide had hit its main target and every important secondary one.
Mazdutide, also known as IBI362, works on two fronts. It stimulates the GLP-1 receptor, as semaglutide-type drugs do, and the glucagon receptor too. Innovent holds an exclusive licence from Eli Lilly to develop and sell it in China, where the trial recruited adults who were overweight or obese.
What GLORY-1 measured
Participants were randomised to 4 mg, 6 mg or placebo in a multicentre, double-blind design. There were two primary endpoints: the percentage change in body weight by week 32, and the share of participants who had lost 5% or more by then. At both doses, mazdutide beat placebo on each. The weight loss kept improving between week 32 and week 48.
Notably, the secondary endpoints were also met. They included the proportion losing 10% or more, and 15% or more, along with shifts in waist size, systolic blood pressure, triglycerides, LDL and total cholesterol, uric acid and the liver enzyme ALT. Innovent said mazdutide was superior to placebo on all of them.
The safety picture was unremarkable, which is what a drugmaker wants to hear. The profile resembled earlier studies, and no new signals appeared during the double-blind period.
What the company says it means
Dr Lei Qian, Innovent’s vice-president for clinical development, said the drug “pioneers a new generation of weight-loss drugs” and that its data now cover more than 1,000 Chinese participants. Innovent describes mazdutide as the first dual GLP-1R/GCGR agonist to succeed in Phase 3.
The next step was regulatory. The company said it would file a new drug application with the Center for Drug Evaluation at China’s National Medical Products Administration, and a later report said the agency took up the filing for long-term weight management. Innovent also planned to present detailed GLORY-1 results at conferences or in journals later in 2024.
Five Phase 3 studies were running at the time: GLORY-1 and GLORY-2 in people with overweight or obesity, plus three DREAMS studies in type 2 diabetes. GLORY-2 tests a higher 9 mg dose.
Sources
- Innovent's Phase III obesity treatment trial meets all endpoints – Clinical Trials Arena
- Innovent's mazdutide accepted by China's NMPA for chronic weight management – Bariatric News
- Innovent Announces the First Phase 3 Clinical Trial of Mazdutide in Chinese Adults with Overweight or Obesity Met the Primary and All Key Secondary Endpoints – BioSpace (Innovent release)
