Mazdutide
InvestigationalMazdutide 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
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.
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) |
Efficacy and Safety of Mazdutide in Adults With Prediabetes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (DREAM-PRE)
Achieving Sustained Weight Control Via Exercise, Nutrition & Drugs (Mazdutide) (ASCEND- 1 Trial)
A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight
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)
A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
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
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
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)
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
QUAdruple Therapy With RASi, Empagliflozin, Finerenone, and Mazdutide in Type 2 Diabetes and Early Treatment of Nephropathy(QUARTET-DKD)
Mazdutide Plus Levonorgestrel-Releasing Intrauterine System for Fertility-Sparing Treatment in Overweight or Obese Patients With Atypical Endometrial Hyperplasia or Early Endometrioid Endometrial Cancer
Efficacy and Safety of Mazdutide Injection for the Treatment of Overweight Patients With Compensated Cirrhosis and Clinically Significant Portal Hypertension
Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial
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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Compared With
11 comparisonsConditions Studied
3 entries- Mazdutide for Obesity GLORY-1 and GLORY-2 are separate Chinese phase 3 placebo-controlled weight trials. GLORY-2 reported a 60-week mean change of -16.6…
- Mazdutide for Type 2 Diabetes Chinese randomized trials report HbA1c improvement versus placebo and, in a distinct background-therapy trial, versus dulaglutide.…
- Mazdutide for Non-Alcoholic Fatty Liver Disease A mazdutide mouse and hepatocyte study reports liver-fat and inflammatory findings, but it does not establish treatment of fatty-l…