Innovent is looking to file an NDA to the Chinese authorities for mazdutide in type 2 diabetes in 2024. Image credit: Shutterstock / Halfpoint.

Innovent Biologics has said that its type 2 diabetes (T2D) candidate mazdutide was superior to Eli Lilly’s Trulicity (dulaglutide) in a Phase III trial.

The study results demonstrated that mazdutide was superior to Trulicity for glycaemic control, as well as showing multiple cardiometabolic benefits including weight loss, blood lipid, blood pressure, serum uric acid and liver enzymes.

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The Phase III DREAMS-2 trial (NCT05606913) investigating mazdutide in Chinese patients with T2D met the primary endpoint of reducing glycated haemoglobin (HbA1c) after 28 weeks.

Key secondary endpoints also showed mazdutide’s superior benefits in both glucose-lowering and weight loss. The safety profile was consistent with previous trials, with no new safety signals observed.

DREAMS-2 is a non-inferiority, multi-centre, randomised Phase III trial which enrolled 731 patients to receive mazdutide 4mg, mazdutide 6mg or dulaglutide 1.5mg for 28 weeks.

The company is also running a head-to-head study of mazdutide and Novo Nordisk’s Ozempic (semaglutide), the DREAMS-3 study (NCT06184568).

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Innovent clinical development vice president Dr Lei Qian, said that the company plans to submit a new drug application (NDA) for mazdutide in T2D to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China this year.

Mazdutide is a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist. Innovent secured the rights to develop mazdutide in China from Lilly back in 2019. Lilly retains the rights to develop the therapy outside of China, with the candidate remaining in its pipeline as a Phase II candidate for obesity.

In January, Innovent announced that the Phase III GLORY-1 trial of mazdutide met both of its primary endpoints in patients with obesity.

Type 2 diabetes landscape

Outside of China, the T2D landscape is dominated by Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro (tirzepatide).

A GlobalData report predicts the T2D market to be worth $136bn in 2029 across the nine major markets (9MM: US, France, Germany, Italy, Spain, UK, China, India, and Japan). The US will maintain a majority of the global market share at 48.5%.

GlobalData is the parent company of the Clinical Trials Arena.