Mazdutide

Also known as IBI362 · LY3305677 · Xinermei (China)

Approved outside the USAHuman trial evidence What this means

Mazdutide is a once-weekly peptide that activates both the GLP-1 and glucagon receptors. It was approved in China in June 2025 for long-term weight management and in September 2025 for glycaemic control in type 2 diabetes, and it remains investigational in the United States, where phase 2 trials have been run. Randomized trials have reported body-weight and HbA1c reductions versus placebo or dulaglutide, with gastrointestinal events the most common adverse events; this entry summarizes them for research reference only.

US status: Approved outside the US
Evidence: Grade A
Half-life: 150.9 to 403.5 hours (phase 1b in overweight/obesity) ⁸
Class: Dual GLP-1 receptor and glucagon receptor agonist; long-acting oxyntomodulin analogue peptide

Studied in: Appetite & body weight · Metabolic & insulin research · Class: GIP and glucagon co-agonists

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Key takeaways

Mazdutide is a once-weekly dual GLP-1 and glucagon receptor agonist approved in China in 2025 for weight management and type 2 diabetes; it is not FDA-approved ^2,10.
In GLORY-1 (610 Chinese adults), mean weight change at 48 weeks was -11.00% (4 mg) and -14.01% (6 mg) versus +0.30% with placebo ^1.
In GLORY-2 (461 Chinese adults with BMI 30 or higher), mazdutide 9 mg produced a mean weight change of -16.65% at 60 weeks versus -1.50% with placebo ^5.
In two phase 3 type 2 diabetes trials, mazdutide lowered HbA1c by up to -2.15% versus -0.14% with placebo at 24 weeks, and was superior to dulaglutide 1.5 mg at 28 weeks ^3,4.
Vomiting (53.1% vs 1.3%), nausea (46.9% vs 3.2%) and diarrhoea (39.4% vs 6.5%) were the most common adverse events with 9 mg in GLORY-2 ^5.

Development stage

Where Mazdutide sits between laboratory work and regulatory approval.

Preclinical
Animal and cell work
Phase 1
First human safety studies
Phase 2
Early efficacy signal
Phase 3
Confirmatory trials
Approved (current)
Cleared by a regulator

Stage comes from the regulatory record and ClinicalTrials.gov studies naming the compound (for compounds approved nowhere, only completed trials or trials with posted results count) (checked 2026-10-24). A registered trial is not a result.

Mechanism of action

Mazdutide is a long-acting synthetic analogue of oxyntomodulin with a fatty-acyl moiety, designed to activate both the GLP-1 receptor and the glucagon receptor ⁸.

Receptor pharmacology

The phase 1b report describes potent binding to human and mouse GLP-1 and glucagon receptors in vitro, improved glucose control in mice, and body-weight reduction in both glucagon-receptor and GLP-1-receptor knockout mice, indicating that both receptors contribute ⁸.

Human pharmacology

After subcutaneous administration, absorption was slow (median Tmax 72 hours) and concentrations declined over several weeks, with half-lives of 150.9 to 403.5 hours, supporting once-weekly administration ⁸. Heart-rate increases were noted, most prominently in the 6.0 mg cohort ⁸.

Molecular structure

PubChem CID 167312357 ↗

2D depiction generated from the PubChem record. Depictions are schematic and do not show salt form, counter-ions or conformation.

Formula: C207H317N45O65
Molecular weight: 4476 g/mol
CAS: 2259884-03-0
InChIKey: XRBYWQZGSZWYEJ-HMQIFOERSA-N

Research overview

Human research

Phase 3 trials in Chinese adults reported mean weight changes of -11.00% and -14.01% at 48 weeks with 4 mg and 6 mg (GLORY-1) and -16.65% at 60 weeks with 9 mg (GLORY-2), versus placebo changes of +0.30% and -1.50% ^1,5. In type 2 diabetes, HbA1c fell by -1.57% and -2.15% versus -0.14% with placebo at 24 weeks, and was reduced more than with dulaglutide 1.5 mg at 28 weeks ^3,4. A US phase 2 trial reported weight changes of -7.3% to -18.1% at 32 weeks across doses up to 16 mg versus -0.9% with placebo ^7.

Animal research

In mice, mazdutide (IBI362) improved glucose control and decreased body weight in both glucagon-receptor and GLP-1-receptor knockout animals ^8.

In-vitro research

Mazdutide was reported to bind potently to human and mouse GLP-1 and glucagon receptors in vitro ^8.

Key studies

Ji et al., N Engl J Med (GLORY-1) (2025)
Randomized, double-blind, placebo-controlled phase 3, 48 weeks, 610 participants (NCT05607680)
Model: Humans (Chinese adults with BMI 28 or higher, or 24 to below 28 with a weight-related condition)
At week 32, weight change was -10.09% (4 mg) and -12.55% (6 mg) versus +0.45% with placebo; at week 48, -11.00% and -14.01% versus +0.30%. Adverse events leading to discontinuation occurred in 1.5%, 0.5% and 1.0% ^1.
Gao et al., JAMA (GLORY-2) (2026)
Randomized, double-blind, placebo-controlled phase 3, 60 weeks, 461 treated participants (NCT06164873)
Model: Humans (Chinese adults with BMI 30 or higher, with or without type 2 diabetes)
Mean weight change at week 60 was -16.65% with mazdutide 9 mg versus -1.50% with placebo; 84.3% versus 33.1% reached at least 5% weight reduction; discontinuation due to adverse events was 2.9% versus 0% ^5.
Zhu et al., Nature (phase 3, type 2 diabetes, monotherapy) (2026)
Randomized, placebo-controlled phase 3, 24 weeks plus 24-week extension, 320 participants
Model: Humans (Chinese adults with type 2 diabetes inadequately controlled with diet and exercise)
HbA1c change at week 24 was -1.57% (4 mg) and -2.15% (6 mg) versus -0.14% with placebo; weight change was -5.61% and -7.81% versus -1.26%; diarrhoea, decreased appetite and nausea were most common ^3.
Guo et al., Nature (DREAMS-2) (2026)
Randomized phase 3 versus dulaglutide 1.5 mg, 28 weeks, 731 participants
Model: Humans (Chinese adults with type 2 diabetes on oral antidiabetic drugs)
HbA1c reduction exceeded dulaglutide by 0.24% (4 mg) and 0.30% (6 mg) and weight reduction by 3.78% and 5.76%; gastrointestinal adverse events were more frequent with mazdutide ^4.
Hsia et al., Lancet Diabetes Endocrinol (US phase 2) (2026)
Randomized, double-blind, placebo-controlled phase 2, 48 weeks, 179 participants (NCT06124807)
Model: Humans (US adults with obesity or overweight without type 2 diabetes)
At 32 weeks, weight change was -7.3% (3 to 6 mg), -15.6% (10 mg) and -18.1% (16 mg) versus -0.9% with placebo; discontinuation due to adverse events was highest with 16 mg (20%), mainly gastrointestinal ^7.
Ji et al., Nat Commun (phase 2, China) (2023)
Randomized, double-blind, placebo-controlled phase 2, 24-week interim analysis, 248 participants (NCT04904913)
Model: Humans (Chinese adults with overweight or obesity)
Weight change at week 24 was -6.7% (3 mg), -10.4% (4.5 mg) and -11.3% (6 mg) versus +1.0% with placebo; diarrhoea, nausea and upper respiratory tract infection were most common ^6.

Doses used in published trials

What investigators administered in the cited studies, recorded as a fact about those studies. Not a protocol and not a recommendation.

Full dosing reference, study durations and vial arithmetic →

In GLORY-1 (NCT05607680), Chinese adults with overweight or obesity were randomized 1:1:1 to mazdutide 4 mg, mazdutide 6 mg or placebo, once weekly, for 48 weeks ^1.
In GLORY-2 (NCT06164873), participants were randomized 2:1 to once-weekly subcutaneous mazdutide 9 mg (n=308) or placebo (n=154), with a reduced-calorie diet and increased physical activity, for 60 weeks ^5.
In the phase 3 monotherapy trial in type 2 diabetes, 320 participants were randomized 1:1:1 to weekly subcutaneous mazdutide 4 mg or 6 mg or placebo for 24 weeks, followed by 24 weeks of extended mazdutide treatment ^3.
In DREAMS-2, 731 participants with type 2 diabetes on oral agents were randomized 1:1:1 to mazdutide 4 mg, mazdutide 6 mg or dulaglutide 1.5 mg for 28 weeks ^4.
In the US phase 2 trial (NCT06124807), participants were randomized 3:2:3:3 to once-weekly subcutaneous placebo or mazdutide 3 to 6 mg, 10 mg or 16 mg for 48 weeks; the 3 to 6 mg group maintained 3 mg from week 4 to week 32 before moving to 6 mg ^7.
In the Chinese phase 2 trial (NCT04904913), participants were randomized 3:1:3:1:3:1 to once-weekly mazdutide 3 mg, 4.5 mg, 6 mg or matching placebo, with a 24-week interim analysis ^6.
In the phase 1b study (NCT04440345), participants were randomized 2:1 to once-weekly subcutaneous IBI362 or placebo in three cohorts for 12 weeks, with stepwise 4-week increases to 3.0 mg, 4.5 mg or 6.0 mg ^8.
In the phase 1b type 2 diabetes study (NCT04466904), 43 patients received once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide 1.5 mg subcutaneously for 12 weeks ^9.

Mazdutide draw calculator

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Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

Vomiting
53.1% vs 1.3% placebo
GLORY-2, mazdutide 9 mg, 60 weeks ⁵ · Most adverse events mild to moderate
Nausea
46.9% vs 3.2% placebo
GLORY-2, mazdutide 9 mg, 60 weeks ⁵ · Most adverse events mild to moderate
Diarrhoea
39.4% vs 6.5% placebo
GLORY-2, mazdutide 9 mg, 60 weeks ⁵ · Most adverse events mild to moderate
Adverse events leading to discontinuation
2.9% vs 0% placebo
GLORY-2, mazdutide 9 mg ⁵ · Not graded
Adverse events leading to discontinuation
1.5% (4 mg), 0.5% (6 mg) vs 1.0% placebo
GLORY-1, 48 weeks ¹ · Gastrointestinal events mostly mild to moderate
Discontinuation due to adverse events
Highest with 16 mg (20%)
US phase 2, adults without type 2 diabetes ⁷ · Primarily gastrointestinal disorders
Heart-rate increase
More prominent in the 6.0 mg cohort (numeric rates not given)
Phase 1b, Chinese adults with overweight or obesity, 12 weeks ⁸ · No cardiac event reported in the 6.0 mg cohort
Anti-drug antibodies
2 participants (one each in the 3.0 mg and 4.5 mg cohorts)
Phase 1b, 12 weeks ⁸ · Not described as clinically significant in the report

Emerging safety signals

Heart-rate increases were observed in the phase 1b study, more prominently at 6.0 mg (randomized phase 1b evidence) ^8. ⁸ (2021)
At higher doses tested in the US phase 2 trial, treatment discontinuation due to adverse events reached 20% with 16 mg, mainly gastrointestinal (randomized phase 2 evidence) ^7. ⁷ (2026)
Gastrointestinal adverse events were more frequent with mazdutide than with dulaglutide in DREAMS-2 (randomized phase 3 evidence) ^4. ⁴ (2026)

What is not known: No FDA label exists ^10, and the Chinese prescribing information was not available from an allowed source in this review, so national label dosing is not reported ^2. Most phase 3 data come from Chinese populations ^1,3,4,5. Long-term cardiovascular outcomes and safety beyond 60 weeks were not established in the sources reviewed ^5. The amino-acid sequence is not stated in the abstracts reviewed.

Clinicians and researchers on video

YouTube videos about Mazdutide from clinicians and researchers. Their views, in their own words; not reviewed or endorsed by Amiravo. Compare what they say with the evidence above.

Mazdutide: The GLP-1/Glucagon Receptor Agonist Flying Under the Radar | Dr. Dan | Obesity Expert
Dr. Dan | Obesity Expert · 12K views
New GLP-1 Soon: MAZDUTIDE
Weight Medicine with Dr. Meghan MD · 7K views
The Battle of the Future GLPs: Survodutide versus Mazdutide
Dr. Greg Jones · 5K views

These creators are not affiliated with Amiravo and do not endorse Amiravo or any product linked on this site. Nothing here is medical advice. Video views counted on YouTube as of Oct 24, 2026.

Regulatory status

Status: Approved in China in June 2025 (Xinermei), together with diet and physical activity, for long-term weight management in adults with BMI of 28 or higher, or 24 or higher with at least one weight-related comorbidity, and in September 2025 for glycaemic control in adults with type 2 diabetes, according to a journal summary of the approvals ^2. Not approved by the FDA; an openFDA Drugs@FDA query returned no application record ^10, and a US phase 2 trial was completed ^7.
United States (FDA): Not approved; an openFDA Drugs@FDA query for mazdutide returned no application record ^10. A US phase 2 trial (NCT06124807) has been completed ^7.
Sport (WADA): Mazdutide is not named on the WADA 2026 Prohibited List ^12. Class S0 covers substances with no current approval by any governmental regulatory health authority for human therapeutic use ^12; mazdutide has been approved in China ^2, so whether S0 applies depends on that approval, and athletes should seek WADA or national anti-doping guidance.

Status varies by country and changes over time. How we describe regulatory status.

Quality and testing notes

Mazdutide is a lipidated peptide with a PubChem molecular formula of C207H317N45O65 and molecular weight of about 4476 [11]. A certificate of analysis for reference material would typically include HPLC purity with chromatogram, intact mass by high-resolution mass spectrometry against that formula, confirmation of the acylation site, net peptide content, counter-ion and residual solvent content, and related-substance profiling. Because the full sequence was not available from the sources reviewed, any supplier sequence claim should be checked against the PubChem structure.

How purity testing works · Reading a certificate of analysis

Check a Mazdutide certificate of analysis against its expected mass (4,476 Da)

Storage and handling

No FDA-approved storage instructions exist. Research material should be handled according to the supplier's documentation and certificate of analysis.

Frequently asked questions

Is mazdutide approved anywhere?

Yes, in China: for weight management in June 2025 and for type 2 diabetes in September 2025 ^2. It is not FDA-approved ^10.

How does mazdutide differ from semaglutide?

Mazdutide activates both the GLP-1 and glucagon receptors, whereas semaglutide is a GLP-1 receptor agonist ^8.

What weight change was reported in GLORY-1?

At 48 weeks, -11.00% with 4 mg and -14.01% with 6 mg versus +0.30% with placebo ^1.

What about the 9 mg dose?

In GLORY-2, mean weight change at 60 weeks was -16.65% versus -1.50% with placebo ^5.

Has mazdutide been tested in the US?

Yes, a US phase 2 trial tested doses up to 16 mg in 179 adults ^7.

What adverse events were most common?

Gastrointestinal events: vomiting, nausea and diarrhoea ^5.

What is its half-life?

150.9 to 403.5 hours in a phase 1b study ^8.

Latest indexed research

The GLP-1R/GCGR Dual Agonist Mazdutide Attenuates Liver Steatosis and Decreases Circulating Cholesterol Levels in Mice With Metabolic Dysfunction-Associated Steatotic Liver Disease.
Other · Diabetes, obesity & metabolism · 2026-10-14
A Study of HRS-4729 Injection in Participants With Type 2 Diabetes
Registered trial · humans · Fujian Shengdi Pharmaceutical Co., Ltd. · 2026-09-28
Efficacy and safety of mazdutide vs. dulaglutide in adults with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.
Other · Diabetology & metabolic syndrome · 2026-07-24

Search all studies on Mazdutide (PubMed, Europe PMC, ClinicalTrials.gov)

Listed by publication type from the index record. Inclusion is not an endorsement; open the source to read the findings.

Revision history

Meaningful changes to this entry, with dates and sources. Last reviewed Oct 23, 2026. Typo and layout fixes are not listed.

New section· Schedules by time periodOct 23, 2026
Added week-by-week schedules from registered trials (3 groups, 7 arms).
Source: A Study of IBI362 in Participants With Obesity or Overweight (GLORY-1)
Correction· Quick reference: half-lifeOct 23, 2026
Re-cited the half-life to the phase 1b study that measured it.
Source: PubMed 34430840

References

Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1) N Engl J Med. 2025
Mazdutide: First Approval Drugs. 2025
Mazdutide versus placebo in Chinese adults with type 2 diabetes Nature. 2026
Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes (DREAMS-2) Nature. 2026
Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial JAMA. 2026
A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity Nat Commun. 2023
Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial Lancet Diabetes Endocrinol. 2026
IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study EClinicalMedicine. 2021
A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes Nat Commun. 2022
Drugs@FDA application data queried through openFDA for mazdutide (no matching application record returned on 23 October 2026) openFDA / Drugs@FDA. 2026
PubChem compound record for mazdutide (CID 167312357; CAS 2259884-03-0) PubChem. 2026
International Standard: Prohibited List 2026 World Anti-Doping Agency. 2026
A Study of IBI362 in Participants With Obesity or Overweight (GLORY-1) ClinicalTrials.gov. 2024
A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise (DREAMS-1) ClinicalTrials.gov. 2024
A Study of IBI362 in Participants With Type 2 Diabetes (DREAMS-2) ClinicalTrials.gov. 2024

Last reviewed October 23, 2026 by the Amiravo editorial team.

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Specifications

Molecular formula: C₂₀₇H₃₁₇N₄₅O₆₅
Molecular weight: 4,476 g/mol
CAS number: 2259884-03-0
PubChem CID: 167312357
Format: Lyophilized vial
Vial sizes seen: 5 mg · 10 mg
Type: Single compound

Identifiers from PubChem. Verify against the supplier’s documentation for your lot.

Research stats

How much has been published, not how good it is.

PubMed records: 57
Indexed as human research: 37
Animal-only research: 1
Randomized controlled trials: 10
Registered trials: 45
Trials with posted results: 1

PubMed records per year (current year is partial).

Counts from title/abstract searches of PubMed, ClinicalTrials.gov, openFDA and NIH RePORTER, checked 2026-10-24. Names shared with other substances can inflate counts. FAERS reports are spontaneous and do not establish cause. Funding shows interest, not evidence. Method

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