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A specimen of the Metabolic drawer Drawer A · Metabolic

Mazdutide

Investigational

Mazdutide is a GLP-1 and glucagon receptor dual agonist with randomized weight-management and type 2 diabetes data, mostly from Chinese trials plus one published US phase 2 trial. Innovent reports approval in China for specified adult weight-management and diabetes indications; this does not establish US or EU approval or an indication for other conditions.

IBI362 · LY3305677 · Xinermei

Research evidence
Moderate

Randomized weight and glucose outcomes in studied adults; other proposed indications and long-term outcomes remain uncertain.

Preclinical
8%
Human research
67%

Based on 12 cited sources

Twelve distinct cited records: seven full original human trial publications, one human trial conference abstract, one mouse/hepatocyte study, one systematic review, one Innovent exchange filing, and one FDA warning letter. Registry entries in the trial table are separate records and excluded from these source counts. The open-access count covers two cited scholarly full texts verified publicly readable in this bounded review; it is not an exhaustive access census.

~
Evidence Level
moderate
Innovent's Hong Kong exchange filing reports NMPA approval in China for specified adult chronic weight-management and type 2 diabetes indications.
Investigational
Identity
Also Known As
IBI362 • LY3305677 • Xinermei

Mazdutide (IBI362; LY3305677) activates the GLP-1 and glucagon receptors. Its clinical record includes published randomized trials in adults with obesity, overweight, or type 2 diabetes. The findings below refer to studied products, populations, endpoints, and follow-up periods; they do not establish outcomes for products sold outside regulated channels.

Weight-management evidence

The Chinese GLORY-1 phase 3 trial reported greater weight reduction with mazdutide than placebo at 48 weeks. In the separate GLORY-2 phase 3 trial, Chinese adults with obesity, including a minority with type 2 diabetes, had a mean weight change at week 60 of -16.65% with mazdutide and -1.50% with placebo. GLORY-2 reported vomiting, nausea, and diarrhea more often with mazdutide, and adverse-event discontinuation was 2.9% versus 0%. GLORY-1, PMID 40421736 · GLORY-2, PMID 42251595

A Chinese phase 2 trial in 80 adults with obesity without diabetes reported a 24-week weight change of -12.78% versus +1.80% with placebo. A distinct US phase 2 trial randomized 179 adults with obesity or overweight without type 2 diabetes. Its primary 32-week efficacy-estimand analysis reported mean changes of -7.3%, -15.6%, and -18.1% across study groups versus -0.9% with placebo; adverse-event discontinuation was highest in the top-dose group at 20%. The shorter analysis, different estimand, and smaller US sample prevent a direct ranking against the Chinese studies. Chinese phase 2, PMID 41875890 · US phase 2, PMID 42628555

Type 2 diabetes evidence

An earlier Chinese phase 2 randomized trial studied adults with type 2 diabetes inadequately controlled with diet and exercise or stable metformin. In a separate phase 3 placebo-controlled trial of 320 Chinese adults, mean HbA1c changes at week 24 were -1.57% and -2.15% in the two mazdutide groups versus -0.14% with placebo. Another phase 3 trial randomized 731 Chinese adults with type 2 diabetes receiving background oral medicines; mazdutide improved the 28-week HbA1c and weight endpoints versus dulaglutide in that study. Phase 2, PMID 37943529 · Placebo trial, PMID 41407859 · Dulaglutide trial, PMID 41407860

A June 2026 conference abstract, rather than a full trial report, gives DREAMS-3 results from 349 Chinese adults with early type 2 diabetes and obesity. It reports that mazdutide was superior to semaglutide 1 mg on the proportion reaching both HbA1c below 7% and at least 10% weight loss at week 32; the abstract also reports more nausea and vomiting with mazdutide. The open-label design, selected population, semaglutide dose, and abstract-only reporting limit broader comparative claims. This is a distinct trial, not a second publication of DREAMS-1 or DREAMS-2. ADA 2026 abstract, DOI 10.2337/db26-1226-OR

Limits and safety

Gastrointestinal adverse events recur across the trial program. A 2026 systematic review pooled nine randomized trials and 2,292 participants, but the authors graded several obesity comparisons as very-low certainty because of heterogeneity and few trials. Its participants overlap with primary trial reports; they are not an additional independent trial population. A mouse and hepatocyte study of liver disease cannot establish a human liver indication. Review, PMID 42410325 · Mouse and cell study, PMID 41901218

Regulatory scope

An Innovent filing reports Chinese NMPA approval for chronic weight management in adults meeting the filing’s BMI/comorbidity criteria and for glycemic control in adults with type 2 diabetes. This is sponsor-reported regulatory status; the review did not retrieve an independent NMPA label. The FDA’s March 2026 warning letter calls mazdutide products offered by a cited US seller unapproved new drugs. Neither the Chinese report nor a trial registration implies FDA or EMA approval. Innovent filing · FDA warning letter

Registry records for other metabolic and organ outcomes describe research questions, not posted efficacy results. This dossier does not provide dosing, purchasing, or self-treatment guidance and is not medical advice.

NCT ID Title Peptide Phase Status Completion
NCT07654062
Efficacy and Safety of Mazdutide in Adults With Prediabetes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (DREAM-PRE)
Prediabetes, Impaired Fasting Glucose +1 more
Mazdutide Phase 4 Not yet recruiting Jul 2029 (estimated)
NCT07517042
Achieving Sustained Weight Control Via Exercise, Nutrition & Drugs (Mazdutide) (ASCEND- 1 Trial)
Obesity, Weight Control
Mazdutide Phase N/A Recruiting Dec 2028 (estimated)
NCT06143956
A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight
Obesity, Overweight
Mazdutide Phase 2 Recruiting Feb 2028 (estimated)
NCT07713992
Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide: A Multicenter, Prospective, Randomized Controlled Trial (IIT)
Type 2 Diabetes Mellitus (T2DM), Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus
Mazdutide Phase N/A Not yet recruiting Feb 2028 (estimated)
NCT06817356
A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
Alcohol Use Disorder
Mazdutide Phase 2 Completed May 2026
NCT07718126
Short-term Mazdutide Plus Lifestyle Intervention Versus Placebo for Pre-hepatectomy Prehabilitation in Living Liver Donors With MASLD: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Metabolic Dysfunction-Associated Steatohepatitis, Hepatic Steatosis +1 more
Mazdutide Phase 4 Recruiting Aug 2029 (estimated)
NCT07633639
The Efficacy and Safety of Adjuvant GLP-1 Receptor Agonist Therapy Following Metabolic Bariatric Surgery in Chinese Patients With Obesity: A Prospective, Monocentric, Stratified Randomized Controlled Trial
Obesity
Mazdutide Phase N/A Recruiting May 2028 (estimated)
NCT06184568
A Multicenter, Randomized, Open-label Phase 3 Study Comparing the Efficacy and Safety of IBI362 Versus Semaglutide in Chinese Participants With Early Type 2 Diabetes and Obesity (DREAMS-3)
Type 2 Diabetes, Obesity
Mazdutide Phase 3 Completed Feb 2026
NCT07657676
Effect of Mazdutide on Coronary Plaque Progression in Patients With Coronary Atherosclerosis and Overweight or Obesity: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial
Obesity & Overweight, Coronary Heart Disease
Mazdutide Phase 4 Not yet recruiting Dec 2027 (estimated)
NCT07775846
QUAdruple Therapy With RASi, Empagliflozin, Finerenone, and Mazdutide in Type 2 Diabetes and Early Treatment of Nephropathy(QUARTET-DKD)
Type 2 Diabetic Kidney Disease
Mazdutide Phase 4 Not yet recruiting Jun 2029 (estimated)
NCT07781150
Mazdutide Plus Levonorgestrel-Releasing Intrauterine System for Fertility-Sparing Treatment in Overweight or Obese Patients With Atypical Endometrial Hyperplasia or Early Endometrioid Endometrial Cancer
Obesity, Overweight +3 more
Mazdutide Phase 2 Not yet recruiting Jun 2031 (estimated)
NCT07797101
Efficacy and Safety of Mazdutide Injection for the Treatment of Overweight Patients With Compensated Cirrhosis and Clinically Significant Portal Hypertension
Cirrhosis, Portal Hypertension +2 more
Mazdutide Phase N/A Not yet recruiting May 2029 (estimated)
NCT07767552
Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial
Diabetes Mellitus, Type 2
Mazdutide Phase N/A Not yet recruiting Jun 2029 (estimated)
NCT07654062 Not yet recruiting

Efficacy and Safety of Mazdutide in Adults With Prediabetes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (DREAM-PRE)

Mazdutide Phase 4 Completion: Jul 2029 (estimated)
NCT07517042 Recruiting

Achieving Sustained Weight Control Via Exercise, Nutrition & Drugs (Mazdutide) (ASCEND- 1 Trial)

Mazdutide Phase N/A Completion: Dec 2028 (estimated)
NCT06143956 Recruiting

A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight

Mazdutide Phase 2 Completion: Feb 2028 (estimated)
NCT07713992 Not yet recruiting

Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide: A Multicenter, Prospective, Randomized Controlled Trial (IIT)

Mazdutide Phase N/A Completion: Feb 2028 (estimated)
NCT06817356 Completed

A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

Mazdutide Phase 2 Completion: May 2026
NCT07718126 Recruiting

Short-term Mazdutide Plus Lifestyle Intervention Versus Placebo for Pre-hepatectomy Prehabilitation in Living Liver Donors With MASLD: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Mazdutide Phase 4 Completion: Aug 2029 (estimated)
NCT07633639 Recruiting

The Efficacy and Safety of Adjuvant GLP-1 Receptor Agonist Therapy Following Metabolic Bariatric Surgery in Chinese Patients With Obesity: A Prospective, Monocentric, Stratified Randomized Controlled Trial

Mazdutide Phase N/A Completion: May 2028 (estimated)
NCT06184568 Completed

A Multicenter, Randomized, Open-label Phase 3 Study Comparing the Efficacy and Safety of IBI362 Versus Semaglutide in Chinese Participants With Early Type 2 Diabetes and Obesity (DREAMS-3)

Mazdutide Phase 3 Completion: Feb 2026
NCT07657676 Not yet recruiting

Effect of Mazdutide on Coronary Plaque Progression in Patients With Coronary Atherosclerosis and Overweight or Obesity: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial

Mazdutide Phase 4 Completion: Dec 2027 (estimated)
NCT07775846 Not yet recruiting

QUAdruple Therapy With RASi, Empagliflozin, Finerenone, and Mazdutide in Type 2 Diabetes and Early Treatment of Nephropathy(QUARTET-DKD)

Mazdutide Phase 4 Completion: Jun 2029 (estimated)
NCT07781150 Not yet recruiting

Mazdutide Plus Levonorgestrel-Releasing Intrauterine System for Fertility-Sparing Treatment in Overweight or Obese Patients With Atypical Endometrial Hyperplasia or Early Endometrioid Endometrial Cancer

Mazdutide Phase 2 Completion: Jun 2031 (estimated)
NCT07797101 Not yet recruiting

Efficacy and Safety of Mazdutide Injection for the Treatment of Overweight Patients With Compensated Cirrhosis and Clinically Significant Portal Hypertension

Mazdutide Phase N/A Completion: May 2029 (estimated)
NCT07767552 Not yet recruiting

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

Mazdutide Phase N/A Completion: Jun 2029 (estimated)
12 Sources 8 Human 1 Preclinical

Use the source links in the research discussion above to inspect the referenced records.

This dossier synthesizes available evidence from peer-reviewed literature, regulatory documents, and clinical trial registries. Evidence strength labels summarize the cited material for this entry and should be read alongside its population, model, and study limitations.

For complete methodology details, see our Methodology page.

Important Disclaimer

This dossier is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.

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Conditions Studied

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