China puts down marker in diabetes, weight-loss drug research

Two phase III clinical studies of a China-developed weight-loss and diabetes drug have been published in Nature, representing a milestone for China's growing presence in global metabolic disease research.

The studies evaluated the impact of mazdutide, a dual GCG/GLP-1 receptor agonist developed by Innovent Biologics, on Chinese patients with type 2 diabetes. According to the articles, the phase III trials, known as DREAMS-1 and DREAMS-2, showed the drug improved blood sugar control and reduced body weight versus placebo or the GLP-1 drug dulaglutide.

The journal published the two phase III studies back-to-back, a rare occurrence in the metabolism and endocrinology field. 

Mazdutide has already drawn attention after a separate phase III weight-loss study, GLORY-1, was published in The New England Journal of Medicine in May. Innovent said the drug is the first GLP-1-based therapy to have phase III results published in both journals. 

In the DREAMS studies, mazdutide met primary endpoints for glycaemic control and weight reduction, while also improving several cardiometabolic, liver and kidney markers. Safety and tolerability were consistent with earlier trials, with no new safety signals reported, the researchers said.

Innovent said mazdutide's dual mechanism — stimulating GLP-1 to enhance insulin secretion and suppress appetite, while activating GCG to increase energy expenditure and reduce liver fat — may be particularly suited to these characteristics.

In October, Innovent released results from a head-to-head comparative study, known as DREAMS-3, comparing mazdutide with semaglutide, one of the world's best-selling drugs for diabetes and weight loss. The study showed that, among Chinese patients with type 2 diabetes and obesity, mazdutide delivered superior outcomes in blood glucose control, weight reduction and overall metabolic benefits.

China's drug regulator approved mazdutide as a Category 1 innovative drug in June for long-term weight management in adults with obesity and related metabolic conditions. According to Innovent, it is the world's first authorized GCG/GLP-1 dual-target drug for weight loss.

While China's GLP-1 weight-loss market has expanded rapidly in recent times, it remains at an early stage of development. Industry estimates show overall penetration of the GLP-1 drug class in China is still below 1 percent, with the market long saturated by imported products.

Before mazdutide's approval, there were four GLP-1-based weight-loss drugs available in China: liraglutide, benaglutide, semaglutide and tirzepatide. The first two are short-acting drugs produced by domestic companies, while semaglutide and tirzepatide are longer-acting imported therapies.

Innovent said mazdutide has also been approved in China for type 2 diabetes and is being tested across multiple late-stage trials covering obesity and related complications, including adolescent obesity.

China's drug regulator has also accepted a market entry application for a higher-dose formulation for adult weight control, Innovent added.