Innovent Biologics has reported that the Phase III GLORY-1 clinical trial of mazdutide in Chinese adults who are overweight or obese met the primary and all crucial secondary endpoints.
The latest development paves the way for filing an NDA with the Center for Drug Evaluation of China’s National Medical Products Administration soon.
The NDA for mazdutide, a glucagon-like peptide-1 receptor and glucagon receptor dual agonist, is intended for weight management indication.
GLORY-1 is a multicentre, double-blind, randomised, placebo-controlled trial designed to assess the safety and efficacy of mazdutide in 610 Chinese adult individuals who are overweight or obese.
These subjects were randomised to receive either mazdutide or a placebo for 48 weeks.
At week 32, mazdutide was found to be superior in percentage variation in body weight and the proportion of subjects achieving significant weight loss versus placebo, thereby meeting both primary endpoints.
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The weight-loss efficacy was demonstrated to improve from weeks 32 to 48.
The trial’s secondary endpoints, including changes in waist circumference, systolic blood pressure, and levels of triglycerides, total cholesterol and serum uric acid, among others, were also met.
In the trial’s double-blind treatment period, mazdutide’s safety profile was consistent with that observed in previous trials without any new safety issues identified.
Innovent has an exclusive licence deal in place with Eli Lilly to develop and market mazdutide in China.
Innovent clinical development vice-president Dr Lei Qian said: “Mazdutide pioneers a new generation of weight-loss drugs as a novel GLP-1R/GCGR dual agonist, with accumulated clinical data on more than 1,000 Chinese participants.
“The results of the GLORY-1 study show that mazdutide has strong weight-loss efficacy with favourable safety and tolerability.”
The announcement follows the commencement of the Phase III GLORY-2 trial, which is testing a higher 9mg dose of mazdutide in adults with obesity in China.