Mazdutide: clinical evidence record
Also known as: IBI362, LY3305677, Xinermei
Oliver Mackman · Editorial director · Best Business Loans Ltd (16833937)
Last updated 2026-07-19
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AI-friendly summary · Mazdutide
The clinical programme runs from a phase 1b multiple-ascending-dose study (EClinicalMedicine, 2022) through phase 2 trials in overweight and obesity (Nature Communications, 2023) and type 2 diabetes (Diabetes Care, 2024) to phase 3 results published in the New England Journal of Medicine in 2025 and Nature in 2026. Gastrointestinal adverse events are the most frequently reported tolerability issue. Mazdutide received its first regulatory approval in China in June 2025 for long-term weight management, followed in September 2025 by approval in China for glycaemic control in type 2 diabetes. It has no marketing authorisation in the United Kingdom, so it is not a licensed medicine here and cannot be lawfully supplied for human use. A further caution specific to this compound is that the pivotal evidence base is drawn overwhelmingly from Chinese trial populations, so generalisability to a UK population has not been established. Product sold online under this name in the UK is unlicensed and unverified.
Mechanism of action
How Mazdutide works
Synthetic peptide based on the oxyntomodulin scaffold, acting as a dual agonist at the glucagon receptor and the GLP-1 receptor. Licensed by Innovent Biologics from Eli Lilly and developed principally in Chinese trial populations. The glucagon component is associated in published pharmacology with hepatic and energy-expenditure effects alongside the GLP-1 appetite and glycaemic effects.
Top peer-reviewed citations
Selection of the most-cited peer-reviewed literature on Mazdutide. Where a verified PMID or DOI is shown, the citation links to the original record. Other citations list the title, authors, journal and year so the reader can locate the paper through the journal index or the PubMed search linked below. PeptideClear publishes editorial commentary, not clinical guidance.
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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, Gao L, Jiang H, et al.. EClinicalMedicine, 2022.
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A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity
Ji L, Jiang H, Cheng Z, et al.. Nature communications, 2023.
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Efficacy and Safety of Mazdutide in Chinese Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
Zhang B, Cheng Z, Chen J, et al.. Diabetes care, 2024.
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Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight
Ji L, Jiang H, Bi Y, et al.. The New England journal of medicine, 2025.
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Mazdutide: First Approval
Shirley M. Drugs, 2025.
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Mazdutide versus placebo in Chinese adults with type 2 diabetes
Zhu D, Zhao J, Cai H, et al.. Nature, 2026.
Full PubMed search: https://pubmed.ncbi.nlm.nih.gov/?term=mazdutide.
Registered clinical trials
As of 2026-07-13, no interventional trials for Mazdutide are listed on ClinicalTrials.gov or the ISRCTN registry. This is itself informative: much of the Mazdutide evidence base is preclinical, which is why the evidence grade above matters.
Source: ClinicalTrials.gov and the ISRCTN registry, refreshed 2026-07-13. See the peptide clinical-trials tracker for the full picture across compounds.
UK regulatory status
Plain-English summary of where Mazdutide sits under the four UK and international frameworks that govern peptide supply. Editorial commentary, not legal advice.
- Misuse of Drugs Act 1971: Not controlled under the Misuse of Drugs Act 1971.
- Psychoactive Substances Act 2016: Not scheduled under the Psychoactive Substances Act 2016.
- MHRA medicines classification: No UK marketing authorisation as a medicine.
- WADA Prohibited List: Not currently listed on the WADA Prohibited List.
Risks and unknowns
What the literature does not yet show about Mazdutide
Known concerns
- Mazdutide has been studied in randomised human trials, which is a materially stronger position than most compounds on this site. Trial populations, endpoints and durations are still narrower than everyday use, so results describe the trial, not every person.
- The body of published work on Mazdutide is small, at 6 papers in our record. A thin literature means individual findings carry more weight than they should, and one contrary result can change the picture.
- There are no registered interventional clinical trials for Mazdutide on ClinicalTrials.gov or the ISRCTN registry. Nobody is currently running the study that would answer the safety and efficacy questions.
- Mazdutide holds no UK marketing authorisation, so nothing you can buy has been assessed by a regulator, released by batch, or dispensed by an accountable pharmacy. Purity, dose accuracy and sterility rest entirely on the seller's own documentation.
Open questions in the literature
- Long-term outcomes beyond the duration of the published trials are unknown, and the published trials are considerably shorter than the periods over which people actually use these compounds.
- Interactions between Mazdutide and prescribed medicines are not systematically studied, which matters most for anyone already on treatment for a long-term condition.
- Effects on body composition, and whether any change is maintained after stopping, are among the least well characterised parts of the metabolic literature.
Regulatory note
No UK marketing authorisation as a medicine. Not currently listed on the WADA Prohibited List. The moment a UK seller or commentator makes a therapeutic claim, MHRA can treat the product as an unlicensed medicinal product.
Important: PeptideClear publishes encyclopedia commentary only and does not recommend human use. Speak to a UK-registered prescriber before any medical decision.
Related reading on PeptideClear
Frequently asked questions
What is the evidence level for Mazdutide?
What is the UK regulatory status of Mazdutide?
Has Mazdutide been tested in human clinical trials?
Where can I read the source literature for Mazdutide?
Last verified 2026-07-19. Editorial commentary, not legal or clinical advice. Citations without a linked identifier can be located through the PubMed search and the journal index.