Innovent Biologics Inc. (HKG: 1801), a biopharmaceutical company based in China, has announced the presentation of key results from the first Phase III clinical trial of mazdutide in Chinese adults with overweight or obesity at the ADA Scientific Sessions 2024. The trial, known as GLORY-1 (NCT05607680), is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of mazdutide.
A total of 610 participants were enrolled and randomized to receive mazdutide at doses of 4 mg or 6 mg, or a placebo, over a 48-week double-blind treatment period. Mazdutide demonstrated significant weight loss efficacy, with superior results over placebo in terms of mean percentage change in body weight from baseline and the percentage of participants achieving weight reductions of ≥5%, ≥10%, and ≥15% (P<0.001) at both week 32 and week 48. By week 48, the treatment difference for the mean percentage weight change between mazdutide 6 mg and placebo was -14.31% for the treatment-policy estimand and -14.37% for the efficacy estimand.
Mazdutide was also associated with reductions in multiple cardiometabolic risk factors. Notably, at week 48, the change from baseline in waist circumference was significantly greater with mazdutide 4 mg (-9.48 cm) and 6 mg (-10.96 cm) compared to placebo (-1.48 cm). The pooled mazdutide group showed significant reductions in systolic blood pressure, triglycerides, total cholesterol, low-density lipoprotein cholesterol, serum uric acid, and ALT compared to placebo.
Furthermore, mazdutide showed marked reductions in liver fat content. In an exploratory analysis of GLORY-1, participants with baseline MRI-PDFF ≥10% experienced an average reduction of 80.2% in liver fat content with mazdutide 6 mg, compared to 5.3% with placebo.
Mazdutide, co-promoted by U.S. pharmaceutical giant Eli Lilly, is a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist. It works by activating GLP-1R to reduce appetite and delay gastric emptying, thus facilitating weight loss. Additionally, through GCGR activation, it increases energy expenditure, enhances fatty acid oxidation and lipolysis, and reduces liver fat. In February 2024, the first New Drug Application (NDA) for mazdutide was accepted by China’s National Medical Products Administration (NMPA) for chronic weight management in adults with obesity or overweight.- Flcube.com
