Innovent bags another phase 3 win in China for next-gen Lilly GLP-1 drug

Innovent bags another phase 3 win in China for next-gen Lilly GLP-1 drug

Innovent has pulled off another late-phase win for its Eli Lilly-partnered GLP-1 drug candidate, linking the dual agonist to improved outcomes in type 2 diabetes to tee up a filing for approval in China.

Lilly granted Innovent rights to the dual GLP-1/glucagon receptor agonist mazdutide in China in 2019. At Lilly, the molecule, which is also called LY3305677, has played second fiddle to tirzepatide—the GLP-1 receptor agonist sold as Mounjaro and Zepbound. As tirzepatide emerged as the star of Lilly’s portfolio, the Big Pharma weighed up whether mazdutide represented a meaningful improvement.

Innovent plowed ahead as Lilly mulled its options, reporting phase 3 data in adults with overweight or obesity in January and having a Chinese application for approval in weight management accepted weeks later. The latest update puts Innovent on course to seek approval in China in type 2 diabetes.

The study randomized 320 Chinese adults with type 2 diabetes and insufficient glycemic control using diet and exercise alone to take one of two doses of mazdutide or placebo once a week. After 24 weeks, HbA1c, a measure of blood sugar, had fallen by 1.57% and 2.15%, respectively, in the low and high dose mazdutide cohorts. HbA1c fell by 0.14% in the placebo arm.

The HbA1c data caused the study to hit its primary endpoint. Innovent said the reduction in HbA1c while on mazdutide was sustained through week 48. The Chinese drugmaker also reported significant weight loss, with patients shedding 9.6% after 48 weeks on the high dose, and improvements in measures such as waist circumference and blood pressure.

While cross-trial comparisons can be misleading, the study suggests mazdutide is competitive without providing conclusive evidence that it is an improvement over Lilly’s tirzepatide in type 2 diabetes. Lilly reported a 2.07% reduction in HbA1c after 40 weeks of treatment with the high dose of tirzepatide. HbA1c was higher at baseline in the mazdutide trial, 8.24%, than the tirzepatide study, 7.9%.

The two molecules could compete for market share in China. Lilly won Chinese approval for tirzepatide in diabetes in May and added authorization in weight management late last week. Novo Nordisk previously won approval for semaglutide, the GLP-1 medicine it sells as Ozempic and Wegovy, in both indications in China.

While potentially competing with mazdutide in China, Lilly is developing the dual agonist in other parts of the world. The Big Pharma began a phase 2 study in adults with overweight or obesity in the U.S. in November. But diabetes isn’t currently an area of active study, with Lilly wrapping up a phase 1 trial in the indication in 2021.

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