Successful Phase 3 Trials Propel Innovent’s Mazdutide into China’s Obesity Market

Innovent, a prominent player in the Chinese pharmaceutical landscape, is gearing up to tap into the burgeoning obesity market in China with the successful culmination of phase 3 trials for mazdutide. This dual GLP-1/glucagon receptor agonist, procured from Eli Lilly’s portfolio of obesity assets in 2019, has emerged as a promising contender for weight management.

Having secured the rights to mazdutide, Innovent witnessed heightened expectations following a compelling phase 2 readout in May. The preliminary results indicated a noteworthy placebo-adjusted weight loss of 15.4% after 24 weeks with a 9 mg dose of mazdutide. Building on this momentum, the subsequent phase 3 trial, named GLORY-1, enrolled 610 participants, administering either 4 mg or 6 mg doses of mazdutide or a placebo over the 48-week study duration.

Remarkably, GLORY-1 not only met its primary endpoints, demonstrating mazdutide’s superiority over placebo in reducing body weight by week 32 and achieving a weight loss of 5% or more but also excelled in secondary endpoints. These encompassed a weight loss of 10% and above, alterations in waist circumference, systolic blood pressure, triglycerides, and low-density lipoprotein cholesterol. Innovent underscored the comprehensive success of mazdutide across all weight loss and cardiometabolic endpoints, a noteworthy achievement in the drug’s developmental trajectory.

Significantly, the safety profile of mazdutide remained consistent with its prior trials, with no emergence of new safety signals. While a detailed breakdown of efficacy data was not provided in the release, Innovent expressed confidence in the results, intending to present a comprehensive analysis in the future. 

Lei Qian, Vice President of Clinical Development at Innovent, emphasized mazdutide’s robust weight loss efficacy, coupled with favorable safety and tolerability, laying the foundation for an imminent submission of a New Drug Application (NDA) for weight management in China.

Innovent’s strategic foray into the Chinese obesity market is further underscored by the launch of another phase 3 study, GLORY-2, concentrating on a 9 mg dose of mazdutide. This strategic move aligns with Innovent’s commitment to fortifying its product pipeline in the cardiovascular and metabolic domain.

The Chinese obesity market, estimated at a staggering 160 million individuals, has garnered the attention of major pharmaceutical players, including Eli Lilly. Lilly’s completion of a China phase 3 trial for tirzepatide, marketed as Mounjaro for diabetes and Zepbound for obesity in the U.S., attests to the industry’s recognition of the market’s vast potential. Similarly, Novo Nordisk’s approval for semaglutide in China in 2021, albeit off-label for obesity, further underscores the dynamic landscape.

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