Innovent secures another phase 3 success in China for next-gen Lilly GLP-1 drug

Innovent has achieved significant progress in the development of its dual GLP-1 drug, partnered with Eli Lilly, by demonstrating its efficacy in type 2 diabetes. This advancement sets the stage for a regulatory filing in China. The partnership began in 2019 when Lilly granted Innovent rights to mazdutide, also known as LY3305677, for the Chinese market. Although at Lilly mazdutide has been overshadowed by tirzepatide, marketed as Mounjaro and Zepbound, Innovent has continued its development efforts.

Innovent progressed with the clinical development of mazdutide, undeterred by Lilly’s internal assessment of the drug’s potential. Earlier this year, Innovent reported positive phase 3 trial results for adults with overweight or obesity. This led to the acceptance of a Chinese application for weight management approval. The latest findings further support Innovent’s plan to seek approval for treating type 2 diabetes in China.

The clinical study involved 320 Chinese adults with type 2 diabetes who had not achieved sufficient glycemic control through diet and exercise alone. Participants were randomized to receive either a low or high dose of mazdutide, or a placebo, administered weekly. After 24 weeks, the study showed significant reductions in HbA1c levels, a key measure of blood sugar. Specifically, HbA1c levels dropped by 1.57% and 2.15% in the low and high dose mazdutide groups, respectively, compared to a 0.14% decrease in the placebo group.

The significant reduction in HbA1c levels allowed the study to meet its primary endpoint. Innovent reported that the improvement in HbA1c was sustained through week 48. Additionally, patients experienced considerable weight loss, with those on the high dose of mazdutide losing 9.6% of their body weight after 48 weeks. Improvements were also observed in other health metrics, such as waist circumference and blood pressure.

While cross-trial comparisons have limitations, the data indicates that mazdutide is competitive with Lilly’s tirzepatide for managing type 2 diabetes. Lilly’s own studies reported a 2.07% reduction in HbA1c after 40 weeks of treatment with the high dose of tirzepatide. It is noteworthy that baseline HbA1c levels were higher in the mazdutide trial (8.24%) compared to the tirzepatide study (7.9%).

Both mazdutide and tirzepatide could vie for market share in China. Lilly received approval for tirzepatide for diabetes treatment in China in May and recently secured authorization for its use in weight management. Novo Nordisk’s semaglutide, marketed as Ozempic and Wegovy, has also been approved in China for both indications.

While mazdutide and tirzepatide may compete in the Chinese market, Lilly continues developing the dual agonist in other regions. Notably, Lilly initiated a phase 2 study for mazdutide in adults with overweight or obesity in the U.S. in November. However, diabetes is not an active area of study for mazdutide at Lilly, as the company concluded a phase 1 trial for this indication in 2021.

Innovent’s progress with mazdutide illustrates the potential for the drug to become an important treatment option for type 2 diabetes in China, complementing the therapies already available from Lilly and Novo Nordisk. As these developments continue, the competitive landscape for diabetes and weight management treatments in China is set to evolve.