China approves mazdutide for weight management as first GLP-1/glucagon dual agonist
Mazdutide is the first GLP-1/glucagon dual agonist approved in China, but no US approval or filing has been reported.
China has approved mazdutide for chronic weight management, a drug that combines GLP-1 and glucagon receptor activity [2]. Innovent Biologics is selling it in China under a license from Eli Lilly, which holds rights outside China [1][2]. Innovent says mazdutide is the world's first dual GCG/GLP-1 receptor agonist approved for blood sugar control in adults with type 2 diabetes [1].
The reports describe different uses and timing. A competitive-landscape report on the obesity market dates the Chinese approval to June 2025 [2]. Innovent's own announcement, dated Sept. 19, 2025, covers a separate indication — glycemic control in type 2 diabetes [1]. Innovent's release states that mazdutide has received approval for two indications, but it does not detail the weight-management decision [1]. Neither source gives the exact date of the weight-management approval.
Mazdutide is a manufactured version of oxyntomodulin, a hormone the body makes naturally [1]. Like semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound), it acts on the GLP-1 receptor, which is tied to insulin release, lower blood sugar and weight loss. It also activates the glucagon receptor, which the company says may raise energy use and improve fat metabolism in the liver [1].
The approval rests on two Phase 3 trials in Chinese adults with type 2 diabetes. In DREAMS-1, at week 24, average HbA1c — a measure of blood sugar over roughly three months — fell 1.57 percentage points on mazdutide 4 mg and 2.15 points on 6 mg, against 0.14 points on placebo. Body weight fell 5.61% and 7.81%, versus 1.26% on placebo. The share of participants reaching HbA1c below 7% was 68.6% at 4 mg, 87.4% at 6 mg and 10.7% on placebo, and the share hitting both HbA1c below 7% and at least 5% weight loss was 40.6%, 64.9% and 0% [1].
In DREAMS-2, at week 28, HbA1c fell 1.69 points on mazdutide 4 mg and 1.73 points on 6 mg, compared with 1.38 points on dulaglutide 1.5 mg. Weight fell 7.31% and 9.24%, versus 2.86% on dulaglutide. The share reaching HbA1c below 7% was 71.2%, 74.2% and 62.1% [1].
Innovent reports that mazdutide's side-effect profile matched earlier studies of the drug and other GLP-1 receptor agonists, with no new safety signals [1]. China has about 140 million adults with diabetes, roughly one in four cases worldwide, a figure projected to reach 174 million by 2045 [1].
Why it matters for patients
Mazdutide is not approved in the United States, and no US application or US study timeline is described in either report [1][2]. Lilly's rights outside China do not by themselves indicate a US filing, and none has been reported. For US patients, the practical effect is that a newer drug class has cleared a major regulator but is not available here.
Americans already have semaglutide, tirzepatide and orforglipron, which became the first oral small-molecule GLP-1 receptor agonist approved for obesity in April 2026 [2]. Boehringer Ingelheim's survodutide, another GLP-1/glucagon dual agonist, is in Phase 3 [2].
The trial results have limits. They come from Chinese adults with type 2 diabetes, so the numbers may not carry over to other populations [1]. The weight figures are averages from controlled trials, and individual results vary.
What happens next
Four of mazdutide's seven Phase 3 trials are still running: GLORY-2 in adults with moderate to severe obesity, GLORY-3 comparing it with semaglutide in people with overweight or obesity and fatty liver disease, GLORY-OSA in obstructive sleep apnea with obesity, and DREAMS-3 comparing it with semaglutide in type 2 diabetes with obesity [1]. Three have met their main goals: GLORY-1, DREAMS-1 and DREAMS-2 [1].
Innovent also lists started or planned studies in adolescents with obesity, in the liver condition MASH, and in heart failure with preserved ejection fraction [1]. No date for a US filing has been reported.
Sources
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