China approves mazdutide for type 2 diabetes

China's National Medical Products Administration has approved mazdutide for glycemic control in adults with type 2 diabetes, Innovent Biologics announced on September 19, 2025 ^[1]. The approval comes three months after mazdutide was cleared in China for weight management, and it marks the drug's addition to a growing lineup of GLP-1-based treatments available to Chinese patients ^[1].

Mazdutide is a dual receptor agonist that acts on both glucagon (GCG) and GLP-1 receptors, and Innovent describes it as the world's first dual GCG/GLP-1 agonist approved anywhere for glycemic control in type 2 diabetes ^[1]. The company licensed the drug from Eli Lilly for development and sale in China ^[1]. Unlike single-target GLP-1 drugs, mazdutide is designed to also increase energy expenditure and improve liver fat metabolism through its glucagon receptor activity, according to Innovent ^[1].

The approval rests on two late-stage trials. In the DREAMS-1 study, which tested mazdutide alone against placebo in patients with untreated type 2 diabetes, the 6 mg dose lowered HbA1c by 2.15 percentage points at 24 weeks, versus 0.14 points for placebo, and cut body weight by 7.81%, compared with 1.26% for placebo ^[1]. Nearly 87% of patients on the 6 mg dose reached an HbA1c below 7%, versus about 11% on placebo ^[1]. In DREAMS-2, which compared mazdutide with the injectable diabetes drug dulaglutide (1.5 mg) in patients already on oral medications, the 6 mg dose reduced HbA1c by 1.73 points and body weight by 9.24% at 28 weeks, compared with 1.38 points and 2.86% for dulaglutide ^[1]. Innovent reported no new safety signals in either trial, describing mazdutide's safety profile as consistent with other GLP-1 receptor agonists ^[1].

China has roughly 140 million adults with type 2 diabetes, about one in four cases worldwide, and that number is projected to reach 174 million by 2045, according to International Diabetes Federation data cited by Innovent ^[1]. Many of these patients also have obesity, high blood pressure, fatty liver disease or kidney disease, which complicates treatment, according to physicians quoted in the announcement ^[1].

Why it matters for patients

This approval is specific to China and does not change what is available in the United States, where mazdutide is not approved. But it adds to a wider pattern in which multiple companies, not just Novo Nordisk and Eli Lilly, are advancing dual-hormone drugs that combine blood sugar control with weight loss. For US patients following the GLP-1 market, mazdutide's results offer another data point on how a dual GCG/GLP-1 approach compares with existing options like dulaglutide, at least in Chinese trial populations. Innovent's trial data suggest mazdutide produced larger reductions in both blood sugar and body weight than dulaglutide in head-to-head comparisons ^[1], though these results come from company-sponsored trials conducted in China and have not been reviewed by US regulators.

The device used to inject mazdutide also reflects a broader industry trend toward easier-to-use injection pens, with Innovent describing features like a hidden needle and single-use design meant to reduce injection anxiety and improve comfort ^[1].

What happens next

Innovent has five additional Phase 3 trials of mazdutide underway or planned, including DREAMS-3, which compares mazdutide with semaglutide in Chinese adults who have both type 2 diabetes and obesity, and separate studies of mazdutide in adolescents with obesity, in metabolic dysfunction-associated steatohepatitis (MASH), and in heart failure with preserved ejection fraction ^[1]. Three trials, GLORY-1, DREAMS-1 and DREAMS-2, have already met their primary goals, while four others are still ongoing ^[1]. No timeline for a US regulatory filing was included in the announcement, and whether or when mazdutide might reach American patients is not yet known from these sources.