MAZDUTIDE

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Mazdutide (IBI362 / LY3305677): What It Is, How It Works, Benefits, and Research Overview

A comprehensive, evidence-graded review of mazdutide, a once-weekly oxyntomodulin-derived dual glucagon and GLP-1 receptor agonist approved in China for chronic weight management and type 2 diabetes but not approved in the United States.

Medical and regulatory notice: Mazdutide is a prescription medicine approved in China. It is not FDA approved in the United States as of July 14, 2026. Chinese labeling, eligibility, titration, contraindications, and monitoring should not be replaced by vendor directions or research-market dosing claims.

Important chemistry caution: Public chemical databases are not fully consistent about mazdutide’s formula and molecular weight. KEGG and FDA GSRS describe the INN substance as approximately C210H322N46O67 with a molecular weight around 4563 g/mol, while a separate PubChem record lists C207H317N45O65 and approximately 4476 g/mol. A credible COA must identify the exact reference form, counterion, modification state, and standard used rather than quoting a database value without context.

What Is Mazdutide?

Mazdutide, also known as IBI362, LY3305677, and historically OXM3, is a long-acting synthetic analogue of the intestinal peptide oxyntomodulin.

It activates two receptors:

GLP-1 receptor: appetite suppression, glucose-dependent insulin secretion, reduced inappropriate glucagon signaling, and delayed gastric emptying.
Glucagon receptor: increased energy expenditure, lipid mobilization, hepatic metabolic effects, and possible reductions in liver and visceral fat.

Development names
IBI362 / LY3305677

Drug type
Long-acting acylated peptide

Primary receptors
GLP-1R + GCGR

Route
Once-weekly subcutaneous injection

China approval
Obesity and type 2 diabetes

U.S. approval
No

🧬 Structure, Sequence, and Molecular Properties

Oxyntomodulin-derived peptide

Mazdutide is an acylated, long-acting, single-chain peptide analogue of oxyntomodulin. Oxyntomodulin naturally contains the glucagon sequence plus an eight-amino-acid C-terminal extension.

Public sequence representation

Public supplier and patent-derived representations describe a glucagon-like 29-residue pharmacophore containing a noncanonical amino acid at position 2 and a long hydrophilic linker plus fatty-acid modification attached to a lysine side chain.

H-{Aib}-QGTFTSDYSKYLDEKKAK-{AEEA-AEEA-γGlu-fatty-acid}-EFIAWLLKGRG

Sequence caution: Public shorthand may omit exact linker atom numbering, fatty-acid carbon count, terminal chemistry, salt form, or process-specific counterions. The complete INN structural definition and an authenticated reference standard should control release testing.

Key structural features

Oxyntomodulin-derived single-chain peptide
Noncanonical amino acid that improves protease resistance
Long hydrophilic linker
Fatty-acid acylation for albumin association
No required disulfide bridge in the published reference structure
Designed for once-weekly exposure

⚛️ Molecular-property records

Source representation	Formula	Molecular weight
KEGG / INN-oriented record	C₂₁₀H₃₂₂N₄₆O₆₇	Approximately 4563.07 g/mol
FDA GSRS estimated record	C₂₁₀H₃₂₈N₄₆O₆₉ in one displayed estimate	Reference record should be reviewed directly
PubChem CID 167312357	C₂₀₇H₃₁₇N₄₅O₆₅	Approximately 4476 g/mol

Why databases can differ

Peptide databases may represent different counterions, hydration states, terminal groups, linker definitions, neutral forms, or patent compounds. These differences reinforce the need for batch testing against the exact approved or sponsor-controlled reference structure.

📅 Discovery and Approval Timeline

Eli Lilly discovery program

LY3305677 was developed as a long-acting oxyntomodulin analogue with balanced GLP-1 and glucagon receptor activity.

2018: Innovent licensing agreement

Innovent Biologics licensed development and commercialization rights in China from Eli Lilly.

2021: Phase 1b obesity data

Multiple-ascending-dose research showed clinically meaningful short-term weight loss in Chinese adults with overweight or obesity.

2022: High-dose and diabetes phase 1b studies

Studies evaluated doses up to 9 mg and 10 mg and assessed glycemic and weight effects in type 2 diabetes.

2023: Phase 2 obesity publication

A 24-week randomized trial confirmed dose-dependent weight loss and broad cardiometabolic improvements.

2024–2025: GLORY and DREAMS phase 3 programs

Large phase 3 trials evaluated chronic weight management and glycemic control.

May 2025: GLORY-1 published

The phase 3 obesity trial was published in the New England Journal of Medicine.

June 27, 2025: Chinese obesity approval

China’s NMPA approved mazdutide for chronic weight management in eligible adults with overweight or obesity.

September 19, 2025: Chinese diabetes approval

The NMPA approved mazdutide for glycemic control in adults with type 2 diabetes.

2025–2026: Higher-dose development

Innovent submitted a 9 mg obesity application and reported one-year weight-loss results exceeding 20% in a phase 3 program.

Current status

Mazdutide is approved in China but remains unapproved by the FDA and other major Western regulators.

🧠 How Does Mazdutide Work?

Mazdutide activates GLP-1R + GCGR → reduced hunger and food intake + improved insulin and glucagon regulation + increased energy expenditure and fat oxidation → weight reduction, glycemic improvement, and lower visceral and liver fat

1. Appetite and satiety

GLP-1 receptor signaling reduces hunger, increases fullness, and lowers total calorie intake.

2. Glucose-dependent insulin secretion

GLP-1 receptor activation increases insulin secretion when blood glucose is elevated.

3. Glucagon receptor activity

GCGR activation promotes hepatic substrate turnover, lipid oxidation, and energy expenditure.

4. Dual-receptor balance

The molecule is engineered so GLP-1 activity counters the glucose-raising potential of glucagon while preserving energy and liver-metabolic effects.

5. Gastric emptying

GLP-1-related slowing of gastric emptying contributes to early satiety and lower postprandial glucose exposure.

🎯 Receptor Profile and Signaling Balance

Target	Action	Clinical relevance
GLP-1 receptor	Direct agonist	Appetite, insulin secretion, glucose regulation
Glucagon receptor	Direct agonist	Energy expenditure, lipid oxidation, hepatic metabolism
GIP receptor	No intended direct agonism	Distinguishes mazdutide from tirzepatide and retatrutide
cAMP pathway	Primary downstream GPCR pathway	Functional potency at both receptors
Albumin	Reversible binding through acylation	Supports once-weekly pharmacokinetics

Potency-ratio importance

A correct mazdutide product must reproduce activity at both receptors. Sequence identity without the correct GLP-1R-to-GCGR potency balance does not establish pharmaceutical equivalence.

Obesity and Weight-Management Evidence

Phase 2 trial

A 24-week randomized study in Chinese adults with overweight or obesity found clinically meaningful, dose-dependent weight loss with 3 mg, 4.5 mg, and 6 mg once-weekly mazdutide.

Broader metabolic effects

Weight reduction was accompanied by improvements in:

Waist circumference
Blood pressure
Triglycerides and cholesterol measures
Serum uric acid
Liver enzymes
Liver-fat markers

High-dose phase 1b and phase 2 data

Doses of 9 mg and 10 mg produced larger average weight reductions and supported higher-dose phase 3 development.

GLORY-1 Phase 3 Results

Trial design

GLORY-1 enrolled 610 Chinese adults with obesity or overweight plus at least one weight-related condition. Participants received 4 mg, 6 mg, or placebo once weekly for 48 weeks, with the primary efficacy analysis at week 32.

Reported weight effects

Both 4 mg and 6 mg produced significantly greater weight reduction than placebo. Clinically meaningful proportions achieved at least 5%, 10%, and 15% weight loss.

Additional benefits

Reductions were reported in waist circumference, blood pressure, cardiometabolic risk markers, liver fat, and serum uric acid.

Regulatory role

GLORY-1 formed a central part of the evidence supporting China’s 2025 chronic weight-management approval.

High-Dose 9 mg Development

Rationale

The 9 mg program targets adults with moderate-to-severe obesity who may need efficacy approaching metabolic-surgery ranges.

2025 application

Innovent submitted a Chinese marketing application for the 9 mg dose in November 2025.

2026 one-year data

Innovent reported that the high-dose phase 3 program achieved more than 20% average weight loss after one year, with weight still declining and no clear plateau.

Regulatory caution

High-dose approval status should be checked separately from the currently approved lower-dose indication and presentation.

Type 2 Diabetes Evidence

Monotherapy

In a phase 3 trial of 320 adults inadequately controlled with diet and exercise, mazdutide 4 mg and 6 mg reduced A1C by 1.57 and 2.15 percentage points at week 24, compared with 0.14 percentage points for placebo.

Weight effects in diabetes

At week 24, mean weight changes were approximately −5.61% with 4 mg, −7.81% with 6 mg, and −1.26% with placebo.

Combination with oral diabetes drugs

In DREAMS-2, mazdutide produced greater A1C and weight reductions than dulaglutide 1.5 mg in adults receiving background oral therapy.

Composite outcomes

More participants achieved simultaneous glycemic targets and clinically meaningful weight reduction with mazdutide.

DREAMS Phase 3 Program

DREAMS-1

Evaluated mazdutide monotherapy against placebo in adults with type 2 diabetes controlled inadequately by diet and exercise.

DREAMS-2

Compared 4 mg and 6 mg mazdutide with dulaglutide 1.5 mg in adults taking oral diabetes medicines. Mazdutide was superior for A1C and body-weight reduction.

DREAMS-3

Compared mazdutide directly with semaglutide. Innovent reported superior achievement of a composite endpoint combining A1C below 7% with at least 10% body-weight reduction.

Chinese diabetes approval

The DREAMS program supported NMPA approval for glycemic control in September 2025.

Liver Fat and Cardiometabolic Effects

Liver-fat reduction

Dual glucagon/GLP-1 agonism may reduce liver fat through weight loss, improved insulin sensitivity, and glucagon-mediated lipid oxidation.

Liver enzymes

Clinical trials reported improvements in alanine aminotransferase and related hepatic markers.

Visceral fat

Waist and imaging analyses support reductions in central and visceral adiposity.

MASH potential

Mazdutide is biologically relevant to MASLD and MASH research, but approval for obesity or diabetes does not automatically establish an approved MASH indication.

Uric Acid and Kidney-Related Research

Serum uric acid

Mazdutide repeatedly reduced serum uric acid in obesity and diabetes trials.

Potential mechanisms

Weight reduction
Improved insulin sensitivity
Altered renal urate handling
Glucagon-related kidney signaling

Kidney markers

Exploratory studies reported changes in albuminuria and renal metabolic markers, but dedicated kidney-outcome trials are needed.

No gout indication

Mazdutide should not be described as an approved treatment for gout or hyperuricemia unless supported by jurisdiction-specific labeling.

Side Effects and Safety Considerations

Most common adverse effects

Diarrhea
Nausea
Vomiting
Reduced appetite
Constipation
Abdominal discomfort
Injection-site reactions

Heart rate

Dual glucagon and GLP-1 agonism can increase pulse, requiring continued cardiovascular monitoring.

Potential class risks

Pancreatitis
Gallbladder disease
Dehydration and kidney injury
Severe gastrointestinal intolerance
Delayed gastric emptying
Hypoglycemia with insulin or insulin secretagogues
Loss of lean tissue during rapid weight reduction

Glucagon-specific concerns

Potential risks include increased hepatic glucose output, altered amino-acid metabolism, increased heart rate, and changes in liver or lipid metabolism.

Population limitation

Most pivotal evidence has been generated in Chinese participants. Broader international efficacy, pharmacokinetics, and safety require continued evaluation.

Pharmacokinetics and Weekly Dosing

Albumin association

The fatty-acid side chain supports reversible albumin binding and slows clearance.

Protease resistance

The noncanonical residue near the N terminus reduces DPP-4-related degradation.

Once-weekly administration

Structural stabilization and acylation support weekly subcutaneous dosing.

Titration

Approved Chinese dosing uses staged escalation to improve gastrointestinal tolerability. Exact dosing should follow the current Chinese prescribing information.

Regulatory Status

China: weight management

Approved by the NMPA on June 27, 2025 for chronic weight management in eligible adults with overweight or obesity.

China: type 2 diabetes

Approved on September 19, 2025 for glycemic control in adults with type 2 diabetes.

Higher-dose 9 mg

A separate application was submitted for adults with moderate-to-severe obesity.

United States

Mazdutide is not FDA approved.

Other countries

Approval in China does not establish approval or legal human use elsewhere.

🧪 Laboratory Testing Methods

Method	Purpose	Important limitation
RP-HPLC / UPLC	Separates intact mazdutide from deletion peptides, deacylated material, oxidation products, and aggregates.	Area purity does not prove sequence or receptor balance.
LC-HRMS	Confirms intact molecular mass against the stated reference form.	Database formula discrepancies must be resolved.
MS/MS peptide mapping	Confirms sequence, noncanonical residues, linker, and acylation site.	Requires a qualified reference standard.
Amino-acid analysis	Confirms composition and supports net peptide content.	Does not prove residue order or modification location.
Chiral amino-acid analysis	Detects epimerization and incorrect stereochemistry.	Hydrolysis can introduce artifacts.
Linker and fatty-acid analysis	Confirms AEEA units, γ-Glu, fatty-acid identity, and attachment.	Shorthand vendor sequences may omit important details.
Deacylated-peptide assay	Measures loss or absence of the long-acting side chain.	Deacylated peptide may retain partial receptor activity.
Oxidation and deamidation assays	Measure chemically modified degradants.	Some variants require high-resolution separation.
SEC-HPLC	Measures aggregates and high-molecular-weight species.	Small reversible oligomers may require orthogonal analysis.
Net peptide-content assay	Measures actual active peptide mass.	Must correct for water, TFA, acetate, and excipients.
GLP-1R cAMP assay	Measures GLP-1 receptor agonist potency.	Does not establish glucagon-receptor potency.
GCGR cAMP assay	Measures glucagon receptor agonist potency.	Must use comparable cell systems.
Dual-receptor potency ratio	Confirms intended pharmacological balance.	No universal interlaboratory ratio exists.
Albumin-binding assay	Confirms the long-acting acylated design.	Does not fully predict human pharmacokinetics.
Plasma stability	Measures proteolysis and deacylation.	Species differences are important.
Residual-solvent and counterion testing	Measures synthesis solvents and salts.	Does not establish biological potency.
Sterility and endotoxin	Required for finished injection products.	Raw-peptide purity cannot establish injectable safety.
Particulate matter	Measures visible and subvisible particles.	Requires finished-product testing.
Stability-indicating assay	Tracks oxidation, deamidation, hydrolysis, aggregation, deacylation, and potency loss.	Requires validated forced-degradation studies.

📄 How to Interpret a Mazdutide COA

Identify the exact structural reference: State whether the standard follows the INN/KEGG, FDA GSRS, sponsor, or patent representation.
Do not rely on one database formula: Public records differ.
Verify the full peptide sequence and every noncanonical residue.
Confirm the linker, fatty-acid chain, and exact attachment site.
Use LC-HRMS plus MS/MS peptide mapping.
Confirm stereochemistry: Epimers may have the same nominal mass.
Measure deletion peptides, deacylated material, oxidation, deamidation, hydrolysis, and aggregates.
Report net peptide content: “99% HPLC purity” is not the labeled milligram amount.
Test GLP-1R and GCGR potency separately.
Confirm the receptor-potency ratio.
For injectable products, require sterility, endotoxin, particles, fill accuracy, container closure, and stability.
Do not infer regulatory equivalence: A vendor COA cannot establish equivalence to the approved Chinese drug product.

📊 Mazdutide vs Semaglutide vs Tirzepatide vs Retatrutide

Feature	Mazdutide	Semaglutide	Tirzepatide	Retatrutide
Receptors	GLP-1R + GCGR	GLP-1R	GIPR + GLP-1R	GIPR + GLP-1R + GCGR
Type	Acylated peptide	Acylated peptide	Acylated peptide	Acylated peptide
Route	Weekly injection	Weekly injection	Weekly injection	Weekly injection in trials
China approval	Yes	Yes, selected products	Yes, selected products	No
FDA approval	No	Yes	Yes	No

Mazdutide vs Survodutide vs Pemvidutide

Compound	Receptors	Development emphasis
Mazdutide	GLP-1R + GCGR	Obesity and diabetes
Survodutide	GCGR + GLP-1R	Obesity and MASH
Pemvidutide	GCGR + GLP-1R	Obesity and MASH

Mazdutide vs Dulaglutide vs Semaglutide in Diabetes

Feature	Mazdutide	Dulaglutide	Semaglutide
Mechanism	GLP-1R + GCGR	GLP-1R	GLP-1R
Weight effect	Greater than dulaglutide in DREAMS-2	Moderate	High for a mono-agonist
Head-to-head evidence	Compared with both agents in Chinese trials	Active comparator	Active comparator in DREAMS-3
Global approval	China only	Multiple markets	Multiple markets

Raw Mazdutide vs Approved Chinese Drug Product

Quality attribute	Raw peptide	Approved finished product
Identity	Sequence, modification, mass	Full sponsor-controlled reference
Potency	Dual receptor assays	Validated release specifications
Microbiology	Bioburden as applicable	Sterility, endotoxin, particles
Delivery	Not established	Validated concentration, container, and dose
Clinical equivalence	Not established by COA	Supported by NMPA-reviewed manufacturing and trials

🖼️ Original Diagram Specifications

Diagram 1: Mazdutide peptide architecture

Show the oxyntomodulin-derived sequence, Aib residue, lysine modification site, AEEA linker, γ-Glu, and fatty-acid side chain.

Diagram 2: Dual-receptor mechanism

Show GLP-1R effects on appetite and glucose and GCGR effects on energy expenditure and liver metabolism.

Diagram 3: China approval timeline

Show June 27, 2025 obesity approval, September 19, 2025 diabetes approval, and the later 9 mg application.

Diagram 4: GLORY-1 pathway

Show weight loss, waist reduction, lower uric acid, liver markers, and blood-pressure improvements.

Diagram 5: DREAMS diabetes results

Show A1C and weight changes versus placebo, dulaglutide, and semaglutide.

Diagram 6: Benefit–risk balance

Show appetite, glycemic, liver, and weight benefits opposite GI effects, heart-rate changes, gallbladder risk, and dehydration.

Diagram 7: COA workflow

Show structural reference, sequence, HRMS, peptide mapping, linker and lipid verification, dual receptor assays, sterility, and stability.

❓ Frequently Asked Questions

Is mazdutide a peptide?

Yes. It is a long-acting acylated oxyntomodulin-derived peptide.

What are its other names?

IBI362, LY3305677, and OXM3.

What receptors does it activate?

The GLP-1 receptor and glucagon receptor.

Does it activate GIP receptors?

No intended direct GIP receptor agonism is part of its mechanism.

Is mazdutide approved?

Yes in China for chronic weight management and type 2 diabetes; no in the United States.

When was it approved in China?

June 27, 2025 for chronic weight management and September 19, 2025 for type 2 diabetes.

What is its molecular formula?

Public databases differ. KEGG lists C210H322N46O67, while one PubChem record lists C207H317N45O65.

What is its molecular weight?

Depending on the database representation, approximately 4476 to 4563 g/mol.

Why do the chemistry records differ?

They may represent different structural forms, terminal groups, counterions, hydration states, or patent versus INN definitions.

How is it administered?

Once-weekly subcutaneous injection.

How much weight loss has been reported?

Approved-dose phase 3 studies showed clinically meaningful double-digit reductions, while a higher-dose 9 mg program reported more than 20% after one year.

Does it lower A1C?

Yes. Phase 3 diabetes trials showed substantial A1C reductions.

What are the most common side effects?

Diarrhea, nausea, vomiting, reduced appetite, constipation, and abdominal symptoms.

How is it different from tirzepatide?

Tirzepatide activates GIP and GLP-1 receptors; mazdutide activates GLP-1 and glucagon receptors.

How is it different from survodutide?

Both target GLP-1R and GCGR, but they have different sequences, receptor balance, clinical programs, and regulatory status.

Does 99% HPLC purity prove authentic mazdutide?

No. Exact structure, sequence, modification, stereochemistry, net content, aggregates, and dual-receptor potency must be verified.

Final Thoughts

Mazdutide is the first glucagon/GLP-1 dual-receptor agonist approved for chronic weight management and type 2 diabetes. Its Chinese approvals are supported by phase 3 evidence showing meaningful reductions in weight and A1C, along with improvements in waist circumference, liver markers, serum uric acid, and other cardiometabolic measures.

The glucagon component distinguishes mazdutide from conventional GLP-1 mono-agonists and may contribute to energy expenditure, liver-fat reduction, and visceral-fat effects. Higher-dose research has reported average one-year weight loss above 20%, although the exact approved status and labeling of the 9 mg presentation must be checked separately.

Analytical authentication is complicated by inconsistent public chemistry records. A legitimate product should be tested against an exact sponsor or regulatory reference for sequence, noncanonical residues, linker and fatty-acid architecture, molecular mass, stereochemistry, impurities, net peptide content, GLP-1R potency, GCGR potency, albumin binding, sterility, particles, and stability. A generic vendor COA cannot establish equivalence to the NMPA-approved Chinese drug product.

📚 References

Ji L, et al. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. New England Journal of Medicine. 2025.
Zhu D, et al. Mazdutide versus placebo in Chinese adults with type 2 diabetes. Nature. 2025.
Guo L, et al. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. Nature. 2026.
Ji L, et al. A phase 2 randomized controlled trial of mazdutide in Chinese adults with overweight or obesity. Nature Communications. 2023.
Zhang B, et al. Efficacy and safety of mazdutide in Chinese patients with type 2 diabetes. Diabetes Care. 2024.
Jiang H, et al. IBI362 in Chinese patients with type 2 diabetes: phase 1b trial. Nature Communications. 2022.
Ji L, et al. IBI362 in Chinese adults with overweight or obesity: phase 1b trial. eClinicalMedicine. 2021.
Ji L, et al. High-dose 9 mg and 10 mg mazdutide in Chinese adults with overweight or obesity. eClinicalMedicine. 2022.
Innovent Biologics. NMPA approval of mazdutide for chronic weight management. June 27, 2025.
Innovent Biologics. NMPA approval of mazdutide for glycemic control in adults with type 2 diabetes. September 19, 2025.
Innovent Biologics. Mazdutide 9 mg marketing application for moderate-to-severe obesity. November 2025.
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Chemistry, Chinese approvals, phase 2 and phase 3 obesity and diabetes evidence, high-dose development, safety, and analytical recommendations were reviewed in July 2026.

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