Mazdutide: the basics
What is it?
A lab-made peptide medicine that switches on two hormone signals, GLP-1 and glucagon, which affect appetite, blood sugar and energy use. It was first made by Eli Lilly.
Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗What do people claim it helps with?
Weight loss and better blood-sugar control in type 2 diabetes.
What has research actually shown?
Large controlled trials in Chinese adults found more weight loss than placebo and better blood sugar than placebo or another diabetes drug. A smaller U.S. trial also found weight loss.
Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗Has this been demonstrated in people?
Phase 3 randomized trials mostly in China, and a phase 2 trial in the U.S., all funded by the companies developing it.
Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗What side effects, risks and unknowns should I understand?
Nausea, vomiting, diarrhoea and reduced appetite were common in trials. In the highest dose group of the U.S. trial, one in five people stopped because of side effects.
FDA safety information 1 ↗Research paper 2 ↗Is it an approved medicine?
No FDA-approved medicine contains mazdutide. It is approved in China, but that does not make it approved or legal to sell as a medicine in the U.S.
FDA safety information ↗Approval here means U.S. FDA approval and applies to a particular product, formulation and use. This is a starting overview, not a complete side-effect list. Sources checked 10 October 2026; independent scientific review pending.
How is it used or studied?
A once-weekly injection in trials and in China. There is no U.S.-approved product; online "research" versions are illegal unapproved drugs.
Different routes and formulations can have different effects. A study of one product does not validate every product with the same peptide name.
A common misunderstanding
Mazdutide is not survodutide, pemvidutide or semaglutide. Approval in one country does not carry over to another.
What should I ask a clinician?
- What diagnosis or goal are we trying to address, and what established options are available?
- Was the expected benefit shown in people like me, using this exact product?
- How could my medicines, health conditions or pregnancy plans affect the risks?
- What monitoring is needed, and what would tell us the treatment is helping or should be stopped?
What do the research words mean?
- Peptide
- A short chain of amino acids, the building blocks of proteins.
- Preclinical
- Research in cells, tissues or animals before dependable treatment evidence in people.
- Controlled trial
- A study comparing a treatment with another treatment or a placebo to help separate its effects from other explanations.
- Biomarker
- A measurement, such as a hormone level. A change does not necessarily mean someone feels better or lives longer.
Mazdutide Evidence & Clinical Profile
Human Study Limits
Mazdutide has been investigated in clinical contexts. Patient outcomes must be evaluated against study size, design, and control cohorts.
Laboratory & In Vivo Assays
Cellular and animal disease models examine receptor binding affinities and signaling cascades, which require human confirmation.
What is Mazdutide?
Mazdutide (IBI362 / LY3305677) is Mazdutide is a once-weekly injectable peptide that activates both GLP-1 and glucagon receptors. Originated by Eli Lilly and developed in China by Innovent Biologics, it was approved in China in 2025 for weight management and type 2 diabetes. It is not FDA-approved; Lilly is studying it in U.S. trials. Aliases include: IBI362, IBI-362, LY3305677, LY-3305677.
- Sequence (one-letter)
- N/A
- Molecular formula
- C207H317N45O65
- Molecular weight
- 4476 g/mol (PubChem computed)
- CAS Number
- 2259884-03-0
- UNII Code
- MB76Z4IBZ5
- PubChem CID
- 167312357
Identifiers checked against PubChem and FDA's Global Substance Registration System on 13 October 2026. FDA substance record ↗ · PubChem record ↗ See all names and codes in the peptide name index.
Clinical Trials & Human Cohorts
Human research can examine tolerability, symptoms or patient outcomes. The design and comparator determine what each result can establish.
Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight [1]
What was reported
At 48 weeks mean weight change was −11.0% and −14.0% in the two mazdutide groups versus +0.3% with placebo.
What limits the conclusion
Chinese adults only, with Chinese BMI cut-offs; funded by Innovent. Gastrointestinal events were the most common side effects.
Mazdutide versus placebo in Chinese adults with type 2 diabetes [2]
What was reported
At 24 weeks HbA1c fell 1.57 and 2.15 percentage points with mazdutide versus 0.14 with placebo; weight fell 5.6% and 7.8% versus 1.3%.
What limits the conclusion
Short placebo-controlled period. Diarrhoea, decreased appetite and nausea were most common. Several authors are Innovent employees.
Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes [3]
What was reported
Both mazdutide groups lowered HbA1c more than dulaglutide (differences −0.24 and −0.30 points) and reduced weight more (differences −3.8% and −5.8%).
What limits the conclusion
Short 28-week comparison against one GLP-1 drug. Gastrointestinal adverse events were more common than with dulaglutide.
Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based phase 2 trial [4]
What was reported
At 32 weeks mean weight change ranged from −7.3% to −18.1% across mazdutide groups versus −0.9% with placebo.
What limits the conclusion
Small trial funded by Eli Lilly. In the highest dose group, 20% stopped treatment because of adverse events, mainly gastrointestinal.
How the compound may work
Mechanisms describe how Mazdutide may affect biological processes. Laboratory findings and patient outcomes answer different questions.
GLP-1 plus glucagon receptor activation
Mazdutide is a dual agonist: one molecule activates both the GLP-1 receptor and the glucagon receptor. Human trials measure the combined effect on weight and glucose; they do not show how much each receptor contributes. [1]
Areas Being Studied
These research topics reflect active areas of scientific exploration, distinct from unverified commercial marketing claims.
Obesity
Weight loss in Chinese and U.S. adults with obesity or overweight. [1]
Type 2 diabetes
Glucose control and weight versus placebo and versus dulaglutide. [3]
U.S. development
Eli Lilly is testing mazdutide outside China, including at higher dose levels than those approved there; U.S. results so far are from phase 2. [4]
Compare the study designs.
| Study | Design / sample | Outcome type | Key limitation |
|---|---|---|---|
| GLORY-1: obesity in China · 2025 [1] | Phase 3 double-blind, placebo-controlled randomized trial; 48 weeks n = 610 |
Clinical endpoint evaluation | Chinese adults only, with Chinese BMI cut-offs; funded by Innovent. Gastrointestinal events were the most common side effects. |
| Type 2 diabetes vs placebo · 2026 [2] | Phase 3 randomized, placebo-controlled trial; 24 weeks plus 24-week extension n = 320 |
Clinical endpoint evaluation | Short placebo-controlled period. Diarrhoea, decreased appetite and nausea were most common. Several authors are Innovent employees. |
| Type 2 diabetes vs dulaglutide · 2026 [3] | Phase 3 randomized, active-controlled trial; 28 weeks n = 731 |
Clinical endpoint evaluation | Short 28-week comparison against one GLP-1 drug. Gastrointestinal adverse events were more common than with dulaglutide. |
| U.S. phase 2: obesity · 2026 [4] | Phase 2 double-blind, placebo-controlled randomized trial; 48 weeks n = 179 |
Clinical endpoint evaluation | Small trial funded by Eli Lilly. In the highest dose group, 20% stopped treatment because of adverse events, mainly gastrointestinal. |
Regulatory Status & Clinical Safety
Regulatory Classification
United States, checked 11 October 2026: not FDA-approved; no record appears in Drugs@FDA or DailyMed. FDA reports it has warned companies illegally selling unapproved mazdutide falsely labelled "for research purposes". China: Innovent announced NMPA approval for chronic weight management in adults (June 2025) and for glycaemic control in adults with type 2 diabetes (September 2025). A Chinese approval does not make it legal or approved in the U.S.
Safety Realities & Impurities
Safety depends on the molecule, formulation, route and evidence. A laboratory purity measurement alone cannot establish safety for human use.
Clinical Trials Registry Records
Official registry records from ClinicalTrials.gov. Study registration does not imply government endorsement or guaranteed efficacy.
A Study of IBI362 in Participants With Obesity or Overweight (GLORY-1) [5]
- Planned enrollment
- 610 (actual enrollment)
- Posted results
- Pending in registry
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Last updated
- 2024-11-12
A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise [6]
- Planned enrollment
- 319 (actual enrollment)
- Posted results
- Pending in registry
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Last updated
- 2024-08-20
A Study of IBI362 in Participants With Type 2 Diabetes [7]
- Planned enrollment
- 731 (actual enrollment)
- Posted results
- Pending in registry
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Last updated
- 2024-08-23
A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight [8]
- Planned enrollment
- 179 (actual enrollment)
- Posted results
- Available
- Sponsor
- Eli Lilly and Company
- Last updated
- 2026-04-21
WADA & Anti-Doping Regulations
WADA Anti-Doping Status
Mazdutide is not prohibited under current World Anti-Doping Agency (WADA) regulations. However, athletes must ensure unregulated preparations or unverified vendor products do not violate Section S0 (Non-approved substances). Last verified: October 2026.
Research Timeline
-
2025
GLORY-1 published
Phase 3 trial in Chinese adults reports 48-week weight results. [1]
-
2025
Approved in China for weight management
Innovent announces NMPA approval for chronic weight management in adults. [9]
-
2025
Approved in China for type 2 diabetes
Innovent announces NMPA approval for glycaemic control in adults with type 2 diabetes. [10]
-
2026
Diabetes trials and U.S. phase 2 published
Two phase 3 diabetes trials and a U.S. obesity trial report results. [4]
-
2026
U.S. status
Not FDA-approved. FDA has warned sellers of mazdutide falsely labelled as a research product. [11]
What Researchers Still Don't Know
Long-term safety profiles
Multi-year observational data in broader heterogeneous cohorts remains uncharacterized.
Optimal dose-response thresholds
Comparative trials optimizing minimal effective exposure versus adverse event rates.
Formulation bioavailability
Differences between oral, subcutaneous, and modified peptide delivery vehicles.
References
Primary sources verified against PubMed / NLM and regulatory databases.
-
Phase 3 RCT
Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight ↗ (external website)
DOI: 10.1056/NEJMoa2411528 ↗ (external website) -
Phase 3 RCT
Mazdutide versus placebo in Chinese adults with type 2 diabetes ↗ (external website)
DOI: 10.1038/s41586-025-10026-w ↗ (external website) -
Phase 3 RCT
Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes ↗ (external website)
DOI: 10.1038/s41586-025-10031-z ↗ (external website) - Phase 2 RCT DOI: 10.1016/S2213-8587(26)00160-9 ↗ (external website)
-
Registry Record
A Study of IBI362 in Participants With Obesity or Overweight (GLORY-1) ↗ (external website)
- Registry Record
-
Registry Record
A Study of IBI362 in Participants With Type 2 Diabetes ↗ (external website)
- Registry Record
- Company press release
- Company press release
-
FDA Safety Communication
FDA's concerns with unapproved GLP-1 drugs used for weight loss ↗ (external website)
