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Mazdutide

Dual glucagon and GLP-1 receptor agonist (oxyntomodulin analogue)

Also known as IBI362, LY3305677

An oxyntomodulin analogue developed primarily in China, further along the regulatory path there than anywhere else. Its approval status is the thing people most often get wrong about it.

Guide updated Sep 2, 2026Literature checked Sep 2, 20263 curated studies43 literature recordsBaseline editorial

Overview

In shortA drug acting on two receptors, based on a natural gut peptide that hits both. It was licensed from Eli Lilly and developed by a Chinese company, with trials run largely in China. Its regulatory position causes most of the confusion: it has moved through Chinese approval while remaining investigational elsewhere, so approved and not approved are both true without naming a country.

Mazdutide is a dual GLP-1 and glucagon receptor agonist based on oxyntomodulin, a naturally occurring gut peptide that hits both receptors. It was licensed from Eli Lilly and developed by Innovent Biologics, with the clinical programme run largely in China.

Its regulatory position is unusual for this compendium and is where most confusion about it comes from: it has moved through the Chinese approval process while remaining investigational elsewhere. A statement that mazdutide "is approved" and a statement that it "is not approved" can both be made truthfully, and neither is useful without naming a country.

Mechanism

In shortIt acts on both the familiar gut-hormone receptor and the glucagon receptor, the same pairing as survodutide but built differently. The natural peptide it derives from has both activities already; this is an attempt to keep that while fixing the natural version's very short life in the body.

Co-agonism at GLP-1 and glucagon receptors, in the same class as survodutide but built on a different backbone. The oxyntomodulin lineage matters mostly as history: the endogenous peptide has this dual activity naturally, and the analogue is an attempt to keep it while fixing a very short half-life.

Evidence

In shortA substantial registered trial programme including late-stage trials, with published results for weight and diabetes. Most of the evidence comes from Chinese populations. That is a real limitation for anyone generalising it rather than a criticism of the trials: body composition, starting weight and background care all differ enough to matter, and the trials usually say so themselves.

A substantial registered trial programme, including phase 3, with results published for weight management and type 2 diabetes endpoints. The registry shows phase 4 activity as well, which is what post-approval study looks like.

Most of the clinical evidence is from Chinese populations. That is a real limitation for anyone generalising it, not a criticism of the trials: body composition, baseline BMI distribution and background care all differ enough to matter, and the trials themselves usually say so.

Safety

In shortStomach effects dominate, as across the class. Raised heart rate and the liver effects of glucagon activity are the class-specific things worth tracking, and they are monitored inside the registered programme. Outside that programme none of it applies, and material sold under this name in grey markets has no relationship to the manufactured product.

Gastrointestinal effects dominate, as across the class. Heart rate increase and the hepatic effects of glucagon agonism are the class-specific things worth tracking, and are monitored in the registered programme.

Outside that programme, none of it applies. Material sold under this name in grey markets has no relationship to the manufactured product and no safety data attaches to it.

Regulatory status

In shortApproved in China for weight management, investigational elsewhere including the US and the EU. Any confident one-sentence claim about its legality is describing one country without saying which. Banned in sport.

Approved in China for weight management; investigational elsewhere, including the United States and the European Union. Any confident single-sentence statement about its legality is describing one jurisdiction without saying which.

Prohibited in sport under WADA rules.

The literature

3 studies indexed. Findings and limitations get equal weight, on purpose.

Always check the primary source

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Everything above is free to read. What an account opens is the evidence underneath it: 3 studies with their limitations, and the regimen each trial actually reported.

  • Every study, with what it found and what it cannot show
  • The limitations, given the same weight as the findings
  • The dose each named trial administered, where recorded
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The wider literature

15 indexed papers and 28 registered trials mentioning Mazdutide, straight from PubMed and ClinicalTrials.gov. 28 of 28 administer it; the rest measure it. These have not been read by us. Unlike the studies above, they carry no findings and no limitations written by anyone here, because writing either would mean claiming a reading nobody has done. They are a starting point for yours.

Registered trials (28)

  1. ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management

    Shanghai Zhongshan Hospital2026NCT07517042

    interventionalnarecruitingn=420

  2. Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide

    Tianjin Medical University2026NCT07713992

    interventionalnanot yet recruitingn=72

  3. Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity

    Innovent Biologics (Suzhou) Co. Ltd.2026NCT07469800

    interventionalphase3recruitingn=336

  4. Mazdutide Plus LNG-IUS for Fertility-Sparing Treatment of AEH or Early Endometrial Cancer

    Tongji Hospital2026NCT07781150

    interventionalphase2not yet recruitingn=128

  5. QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

    Huijie Zhang2026NCT07775846

    interventionalphase4not yet recruitingn=820

  6. Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME)

    West China Hospital2026NCT07718126

    interventionalphase2phase3not yet recruitingn=60

  7. Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE)

    Shandong Provincial Hospital2026NCT07654062

    interventionalphase4not yet recruitingn=150

  8. Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity

    China National Center for Cardiovascular Diseases2026NCT07657676

    interventionalphase4not yet recruitingn=116

  9. A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor

    Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.2026NCT07417306

    interventionalphase3not yet recruitingn=912

  10. Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial

    Yanbing Li2026NCT07767552

    interventionalnanot yet recruitingn=249

  11. A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity

    Innovent Biologics (Suzhou) Co. Ltd.2025NCT06862908

    interventionalphase2recruitingn=141

  12. A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

    Eli Lilly and Company2025NCT06817356

    interventionalphase2completedn=308

  13. A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2

    Innovent Biologics (Suzhou) Co. Ltd.2025NCT06931028

    interventionalphase3recruitingn=260

  14. Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity

    Innovent Biologics (Suzhou) Co. Ltd.2025NCT07000955

    interventionalphase1phase2active not recruitingn=98

  15. A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

    Innovent Biologics (Suzhou) Co. Ltd.2025NCT06937749

    interventionalphase2recruitingn=165

  16. Mazdutide in Type 2 Diabetes With Early-Stage Cognitive Impairment (LIGHT-COG Study)

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School2025NCT07083154

    interventionalphase3recruitingn=420

  17. A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）

    Innovent Biologics (Suzhou) Co. Ltd.2025NCT06884293

    interventionalphase3active not recruitingn=479

  18. This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity

    Innovent Biologics (Suzhou) Co. Ltd.2024NCT06536023

    interventionalphase1completedn=36

  19. A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity

    Innovent Biologics (Suzhou) Co. Ltd.2024NCT06184568

    interventionalphase3completedn=349

  20. Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

    Innovent Biologics (Suzhou) Co. Ltd.2023NCT05793450

    interventionalphase1completedn=20

  21. A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

    Eli Lilly and Company2023NCT06143956

    interventionalphase2recruitingn=1481

  22. A Study of IBI362 9 mg in Chinese Adults With Obesity

    Innovent Biologics (Suzhou) Co. Ltd.2023NCT06164873

    interventionalphase3unknownn=462

  23. A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

    Innovent Biologics (Suzhou) Co. Ltd.2023NCT05628311

    interventionalphase3completedn=319

  24. A Study of IBI362 in Chinese Patients With Type 2 Diabetes

    Innovent Biologics (Suzhou) Co. Ltd.2021NCT04965506

    interventionalphase2completedn=252

  25. A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

    Innovent Biologics (Suzhou) Co. Ltd.2021NCT04904913

    interventionalphase2completedn=328

  26. Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

    Innovent Biologics (Suzhou) Co. Ltd.2020NCT04440345

    interventionalphase1phase2completedn=60

  27. A Study of LY3305677 in Participants With Type 2 Diabetes

    Eli Lilly and Company2019NCT03928379

    interventionalphase1completedn=24

  28. A Study of LY3305677 in Healthy Participants

    Eli Lilly and Company2016NCT02972645

    interventionalphase1completedn=66

Papers (15)

  1. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes.

    Guo L, et al.Nature2026PMID 41407860

    journal articlerandomized controlled trialclinical trial, phase iiicomparative studyresearch support, non-u.s. gov't

  2. Novel GLP-1-based Medications for Type 2 Diabetes and Obesity.

    Son JW, et al.Endocrine reviews2026PMID 41054801

    journal articlereview

  3. Mazdutide versus placebo in Chinese adults with type 2 diabetes.

    Zhu D, et al.Nature2026PMID 41407859

    journal articlerandomized controlled trialclinical trial, phase iiiresearch support, non-u.s. gov't

  4. Beyond weight loss: multisystem benefits of obesity medications.

    Savas M, et al.The lancet. Diabetes & endocrinology2026PMID 42208956

    journal articlereview

  5. Comparative effects of drugs for adults with overweight or obesity: systematic review and network meta-analysis.

    Nong K, et al.BMJ (Clinical research ed.)2026PMID 42419792

    systematic reviewnetwork meta-analysisjournal articlecomparative study

  6. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight.

    Ji L, et al.The New England journal of medicine2025PMID 40421736

    journal articlerandomized controlled trialclinical trial, phase iiimulticenter study

  7. Mazdutide, a dual agonist targeting GLP-1R and GCGR, mitigates diabetes-associated cognitive dysfunction: mechanistic insights from multi-omics analysis.

    Dong W, et al.EBioMedicine2025PMID 40479843

    journal article

  8. Once-Weekly Mazdutide in Obesity or Overweight.

    Zhang Y, et al.The New England journal of medicine2025PMID 40929641

    lettercomment

  9. Once-Weekly Mazdutide in Obesity or Overweight. Reply.

    Ji L, et al.The New England journal of medicine2025PMID 40929642

    lettercomment

  10. Emerging pharmacotherapies for obesity: A systematic review.

    Kokkorakis M, et al.Pharmacological reviews2025PMID 39952695

    journal articlesystematic review

  11. Mazdutide: First Approval.

    Shirley MDrugs2025PMID 41028652

    journal articlereview

  12. Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial.

    Zhang B, et al.Diabetes care2024PMID 37943529

    randomized controlled trialclinical trial, phase iijournal articleresearch support, non-u.s. gov't

  13. Seven glucagon-like peptide-1 receptor agonists and polyagonists for weight loss in patients with obesity or overweight: an updated systematic review and network meta-analysis of randomized controlled trials.

    Xie Z, et al.Metabolism: clinical and experimental2024PMID 39305981

    journal articlesystematic reviewnetwork meta-analysisresearch support, non-u.s. gov't

  14. A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity.

    Ji L, et al.Nature communications2023PMID 38092790

    randomized controlled trialclinical trial, phase iijournal article

  15. Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial.

    Ji L, et al.EClinicalMedicine2022PMID 36247927

    journal article

Discussion

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For Research & Educational Discussion Only. Not Medical Advice

This guide is educational reference material compiled from published literature. It is not medical advice, not a recommendation, and not a substitute for a clinician who knows your history. Nothing here should be used to make a decision about your own health without one.

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