Mazdutide: Uses, Benefits & Research

Mazdutide (IBI362) is the world's first approved GLP-1/glucagon dual receptor agonist, approved in China for Type 2 Diabetes with Phase 3 data showing up to 20.1% weight loss and superiority over semaglutide.

Approved (Other Indication) Well-Established Evidence
Reviewed by Peptide Treatments Medical Advisory Board (Medical Advisory Board) 5 min read

Mazdutide: At a Glance

Mazdutide activates both GLP-1 and glucagon receptors to produce dual therapeutic effects. GLP-1 receptor activation drives insulin secretion, appetite suppression, and delayed gastric emptying. Glucagon receptor activation enhances energy expenditure and promotes hepatic lipid metabolism — a mechanism validated by head-to-head superiority over GLP-1 monotherapy (semaglutide) in the DREAMS-3 trial.

  • Up to 20.1% body weight reduction at 9 mg dose in Phase 3 GLORY-2 trial
  • Superior glycemic control and weight loss vs. semaglutide in head-to-head DREAMS-3 trial
  • Significant HbA1c reduction in Type 2 Diabetes patients
  • Once-weekly subcutaneous injection for patient convenience
  • First-in-class dual GCG/GLP-1 agonist — validates the dual mechanism approach
  • Clinically meaningful body weight reduction demonstrated across multiple Phase 2/3 trials
  • Nausea (common, consistent with GLP-1 class)
  • Vomiting (common)
  • Diarrhea (common)
  • Decreased appetite (common)
  • Constipation (common)
  • Theoretical risk of gastroparesis (GLP-1 class effect)
  • Theoretical risk of thyroid C-cell tumors (GLP-1 class effect)
  • All Phase 2/3 data from Chinese populations — safety in other ethnic groups not established
Approved (Other Indication) Well-Established

Research Summary

Mazdutide has approximately 5-10 completed RCTs, primarily in Chinese populations. The Phase 3 GLORY-2 trial demonstrated up to 20.1% weight loss at 9 mg in adults with obesity. The Phase 3 DREAMS-3 head-to-head trial showed superiority over semaglutide in both glycemic control and weight loss. NMPA (China) approved mazdutide in September 2025 for Type 2 Diabetes glycemic control — making it the world's first approved GCG/GLP-1 dual agonist. However, mazdutide is NOT FDA approved and has no active US IND as of March 2026. All clinical data comes from Chinese populations; efficacy in other ethnic groups is not established.

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What is Mazdutide?

Mazdutide (IBI362) is a synthetic peptide developed by Innovent Biologics (China) that acts as a dual GLP-1 and glucagon (GCG) receptor agonist. It became the world’s first approved GCG/GLP-1 dual receptor agonist when China’s National Medical Products Administration (NMPA) granted approval in September 2025 for glycemic control in adults with Type 2 Diabetes.

Administered as a once-weekly subcutaneous injection at doses of 3 mg, 6 mg, or 9 mg, mazdutide represents a new class of metabolic therapeutics that go beyond GLP-1 monotherapy by adding glucagon receptor activation for enhanced energy expenditure and hepatic lipid metabolism.

Mazdutide is not FDA approved and is only legally available in China as of March 2026.

Mechanism of Action

Mazdutide’s dual mechanism targets two complementary metabolic pathways:

GLP-1 receptor activation: Stimulates glucose-dependent insulin secretion from pancreatic beta cells, suppresses glucagon release from alpha cells, delays gastric emptying, and reduces appetite through central satiety signaling. This is the same mechanism used by semaglutide, tirzepatide, and other GLP-1 receptor agonists.

Glucagon receptor activation: Enhances hepatic energy expenditure, promotes lipid oxidation in the liver, and increases thermogenesis. This additional pathway provides metabolic benefits beyond what GLP-1 alone can achieve — validated by the DREAMS-3 trial showing superiority over semaglutide.

The dual mechanism’s clinical advantage was confirmed in head-to-head Phase 3 data: mazdutide produced greater glycemic control and weight loss than semaglutide monotherapy.

Clinical Evidence

Human Studies

Mazdutide has a robust clinical evidence base of approximately 5-10 RCTs:

  • Phase 3 GLORY-2 (Obesity, 2025): Randomized, double-blind, placebo-controlled trial in Chinese adults with obesity. The 9 mg dose achieved up to 20.1% body weight reduction, meeting all primary and key secondary endpoints.
  • Phase 3 DREAMS-3 (Head-to-Head, 2025): Randomized, open-label, head-to-head comparison against semaglutide in Chinese adults with Type 2 Diabetes. Mazdutide demonstrated superiority in both glycemic control and weight loss — the first Phase 3 trial to show dual agonist superiority over GLP-1 monotherapy.
  • Phase 3 T2D Approval Trial: Randomized, double-blind, placebo-controlled trial leading to NMPA approval. Showed significant glucose-lowering efficacy and potential superiority over dulaglutide in weight reduction.
  • Phase 2 Obesity (PMID: 38092790): 24-week treatment with mazdutide up to 6 mg was safe and produced clinically meaningful weight reduction.
  • Phase 2 T2D (Diabetes Care, 2024): Mazdutide up to 6 mg demonstrated clinically meaningful HbA1c and body weight reductions.

Preclinical

Preclinical studies confirmed dual GLP-1R and GCGR agonist activity, enhanced weight reduction and glycemic control in diabetic/obese animal models, and acceptable safety in toxicology studies.

Drug Interactions & Contraindications

Mazdutide shares class-level drug interaction concerns with other GLP-1 receptor agonists. Insulin and sulfonylureas pose documented additive hypoglycemic risk — dose reduction may be required. Delayed gastric emptying may slow absorption of co-administered oral medications. No specific interaction data exists for non-Chinese populations.

Contraindicated in patients with hypersensitivity to the compound, personal or family history of medullary thyroid carcinoma, and MEN2 syndrome.

Safety & Side Effects

The safety profile is consistent with the GLP-1 receptor agonist class. Common adverse events include nausea, vomiting, diarrhea, decreased appetite, and constipation. No new safety signals were reported in Phase 3 trials. Theoretical concerns based on the dual mechanism include gastroparesis risk, potential hyperglucagonemia, and thyroid C-cell tumor risk (GLP-1 class effect).

All Phase 2/3 data comes from Chinese populations — safety and tolerability in other ethnic groups has not been established.

Honest Bottom Line

Mazdutide is the world’s first approved GLP-1/glucagon dual receptor agonist, with strong Phase 3 data showing up to 20.1% weight loss and head-to-head superiority over semaglutide. The NMPA approval in China validates the dual agonist approach. However, mazdutide is not FDA approved and is only available in China — patients elsewhere cannot legally obtain it. The evidence base is strong for Chinese populations but lacks data in other ethnic groups. No US or EMA trials are publicly announced as of March 2026. Patients globally should continue using approved GLP-1 therapies in their jurisdiction while monitoring mazdutide’s international development.

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Related Conditions

References

  1. 1

    Efficacy and safety of mazdutide in Chinese adults with obesity: the Phase 3 GLORY-2 trial

    Innovent Biologics investigators

    The Lancet 2025 clinical trial
  2. 2

    Mazdutide versus semaglutide in Chinese adults with Type 2 Diabetes: the Phase 3 DREAMS-3 head-to-head trial

    Innovent Biologics investigators

    Diabetes Care 2025 clinical trial
  3. 3

    Safety and efficacy of mazdutide in Chinese overweight adults or adults with obesity: a randomised, double-blind, placebo-controlled phase 2 trial

    Innovent Biologics investigators

    The Lancet Diabetes & Endocrinology 2023 clinical trial
  4. 4

    Mazdutide in Type 2 Diabetes: a Phase 2 randomized, double-blind, placebo-controlled trial

    Innovent Biologics investigators

    Diabetes Care 2024 clinical trial

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