What Is Mazdutide?

1. What Is Mazdutide?

Mazdutide is a once-weekly dual receptor agonist developed by Innovent Biologics under a China license agreement with Eli Lilly. In clinical-trial records, it also appears as IBI362. Innovent describes it as a mammalian oxyntomodulin analogue designed to activate both glucagon-like peptide-1, or GLP-1, receptors and glucagon receptors. In China it is marketed under the brand name Xinermei, according to a 2025 Drugs first-approval review.

That receptor pairing is the main reason mazdutide gets discussed alongside semaglutide, tirzepatide, retatrutide, survodutide, and pemvidutide. They all sit within the broader incretin and metabolic-medicine category.

Common terminology includes:

For nearby explainers, see What Is Semaglutide?, What Is Tirzepatide?, and What Is Retatrutide?.

2. Is Mazdutide Approved?

Yes in China, for specific uses. No in the U.S.

Innovent announced on June 27, 2025 that China’s National Medical Products Administration, or NMPA, approved mazdutide for chronic weight management in Chinese adults with obesity or overweight. Innovent then announced on September 19, 2025 that NMPA approved mazdutide for glycemic control in adults with type 2 diabetes.

Innovent announced on November 25, 2025 that NMPA accepted a supplementary application for a 9 mg dose for long-term weight management in adults with moderate-to-severe obesity. Innovent’s August 2026 interim results presentation still listed the approved China uses as obesity and type 2 diabetes at 4 mg and 6 mg, with 9 mg approval as an upcoming milestone.

The 9 mg application is based on GLORY-2, a Phase 3 trial in 461 Chinese adults with a BMI of 30 or higher. JAMA published the results in 2026: mean body weight fell 16.65% with mazdutide 9 mg at Week 60, versus 1.50% with placebo.

Development Outside China

Innovent’s 2026 pipeline table lists its mazdutide rights as mainland China, Hong Kong, Taiwan, and Macau. Lilly runs development elsewhere under the code LY3305677. No Lilly Phase 3 mazdutide trial was listed on ClinicalTrials.gov as of October 15, 2026.

• A Lilly-funded U.S. Phase 2 trial in 179 adults with obesity or overweight without type 2 diabetes was published in Lancet Diabetes & Endocrinology in August 2026. At Week 32, mean weight change was -7.3% with 3 to 6 mg, -15.6% with 10 mg, and -18.1% with 16 mg, versus -0.9% with placebo, under the efficacy estimand. Twenty percent of the 16 mg group stopped treatment because of adverse events, mainly gastrointestinal.
• A Lilly Phase 2 trial in alcohol use disorder, NCT06817356, enrolled 308 participants and was completed in May 2026. Results had not been posted on ClinicalTrials.gov as of October 15, 2026.

3. How Does Mazdutide Work?

Mazdutide is designed to activate GLP-1 receptors and glucagon receptors. GLP-1 receptor activation is associated with glucose-dependent insulin secretion, delayed gastric emptying, appetite effects, and lower glucagon secretion in many GLP-1 drug labels. Glucagon receptor activation is a different pathway, often discussed in relation to energy expenditure and liver metabolism.

That second receptor is what makes mazdutide different from a single GLP-1 receptor agonist. It also makes the molecule different from a GIP and GLP-1 dual agonist such as tirzepatide.

Key receptor mechanisms:

4. What Was GLORY-1?

GLORY-1 was a Phase 3, randomized, double-blind, placebo-controlled trial of mazdutide in Chinese adults with obesity or overweight. ClinicalTrials.gov lists the trial as NCT05607680, with 610 actual participants.

The trial compared once-weekly subcutaneous mazdutide 4 mg, mazdutide 6 mg, and placebo. The primary outcomes focused on percent change in body weight at Week 32 and the share of participants who reached at least 5% body-weight reduction at Week 32.

Innovent noted that the China chronic weight-management approval was mainly based on GLORY-1. In its approval notice, Innovent reported the following Week 48 results under the efficacy estimand:

The New England Journal of Medicine published the GLORY-1 paper in 2025 under the title “Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight.”

5. What Were DREAMS-1 and DREAMS-2?

DREAMS-1 and DREAMS-2 were Phase 3 type 2 diabetes trials in China. Innovent stated its September 2025 NMPA glycemic-control approval was based on these two trials.

ClinicalTrials.gov lists DREAMS-1 as NCT05628311. It studied mazdutide monotherapy in Chinese adults with type 2 diabetes whose glycemic control remained poor with diet and exercise alone. ClinicalTrials.gov lists 319 enrolled participants, and the trial compared once-weekly mazdutide 4 mg, mazdutide 6 mg, and placebo over 24 weeks. The Nature DREAMS-1 paper, which reports 320 randomized participants, found mean A1C changes of -1.57% with 4 mg and -2.15% with 6 mg, versus -0.14% with placebo, at Week 24.

ClinicalTrials.gov lists DREAMS-2 as NCT05606913. It studied mazdutide as add-on therapy in Chinese adults with type 2 diabetes who were already using oral diabetes medicines. The trial enrolled 731 participants and compared once-weekly mazdutide 4 mg, mazdutide 6 mg, and dulaglutide 1.5 mg.

Nature published the DREAMS-2 paper online on December 17, 2025. The paper states that both mazdutide doses met non-inferiority and superiority criteria versus dulaglutide 1.5 mg for mean A1C change at Week 28. It also reported greater body-weight reductions with mazdutide than dulaglutide and noted the most common treatment-emergent adverse events were diarrhea, nausea, and vomiting.

6. What Is DREAMS-3?

DREAMS-3 is another Phase 3 mazdutide trial in China, listed as NCT06184568. It compared mazdutide 6 mg once weekly with semaglutide 1 mg once weekly in adults with early type 2 diabetes and obesity.

ClinicalTrials.gov lists DREAMS-3 as completed, with 349 actual participants and a study completion date of February 2026. The trial was open-label, meaning participants and investigators knew which drug was given.

The main outcome is a composite endpoint at Week 32: A1C less than 7.0% and at least 10% body-weight loss. This endpoint evaluates glycemic control and weight loss concurrently.

Innovent reported topline results on October 26, 2025:

These are company-reported topline figures, and the comparison used semaglutide at 1 mg, not the 2.4 mg weight-management dose.

7. Mazdutide vs Semaglutide, Tirzepatide, and Retatrutide

Semaglutide is a GLP-1 receptor agonist. Tirzepatide is a GIP receptor and GLP-1 receptor agonist. Retatrutide is an investigational triple GIP, GLP-1, and glucagon receptor agonist. Mazdutide targets GLP-1 and glucagon receptors.

8. Mazdutide Safety Profile

Mazdutide’s safety profile is documented within the GLORY-1 and DREAMS clinical trial programs.

Across GLP-1 and glucagon receptor research, gastrointestinal adverse events are frequently reported. The Nature DREAMS-2 paper named diarrhea, nausea, and vomiting as the most common treatment-emergent adverse events during the trial.

9. Mazdutide Fact Summary

Key details summarizing the current clinical and regulatory status of mazdutide:

10. Bottom Line

Mazdutide is a dual GLP-1 and glucagon receptor agonist, also known by the development code IBI362. Innovent announced China NMPA approvals in 2025 for chronic weight management and for glycemic control in adults with type 2 diabetes. The most significant public data comes from the GLORY-1 trial for obesity or overweight, and the DREAMS trial program for type 2 diabetes. A 9 mg dose remains under review in China, and Lilly’s registered trials outside China have reached Phase 2, not Phase 3.

11. What Is Mazdutide FAQ

• What is mazdutide in simple terms?

  Mazdutide, also called IBI362, is a once-weekly dual GLP-1 and glucagon receptor agonist developed by Innovent with Lilly. It is approved in China for chronic weight management and for glycemic control in adults with type 2 diabetes.

• Is mazdutide FDA-approved?

  No. Mazdutide currently holds China NMPA approval, but it is not approved by the U.S. FDA.

• Why is mazdutide called a dual agonist?

  It is called a dual agonist because it activates GLP-1 receptors and glucagon receptors. That differs from semaglutide, which is described in U.S. labels as a GLP-1 receptor agonist, and from tirzepatide, which is described as a GIP and GLP-1 receptor agonist.

• What was GLORY-1?

  GLORY-1 was a Phase 3 trial in China that randomized 610 adults with obesity or overweight to once-weekly mazdutide 4 mg, mazdutide 6 mg, or placebo. Innovent said the trial supported the China weight-management approval.

• What were the DREAMS trials?

  DREAMS-1 and DREAMS-2 were Phase 3 type 2 diabetes trials in China. Innovent said the China glycemic-control approval was based on these two trials. DREAMS-3 was a separate, open-label Phase 3 comparison with semaglutide 1 mg in adults with early type 2 diabetes and obesity; Innovent reported in October 2025 that mazdutide 6 mg met the primary endpoint.

• Is the 9 mg dose of mazdutide approved?

  Not as of Innovent's August 2026 update. China's NMPA accepted a supplementary application for 9 mg in adults with moderate-to-severe obesity in November 2025, based on the GLORY-2 trial. The approved China uses are at 4 mg and 6 mg.

• Is Lilly developing mazdutide outside China?

  Yes, at an earlier stage. Lilly-sponsored U.S. trials include a Phase 2 obesity trial published in 2026 and a completed Phase 2 alcohol use disorder trial. No Lilly Phase 3 mazdutide trial was listed on ClinicalTrials.gov as of October 15, 2026.

12. Sources