Mazdutide
Also known as: IBI362, Mazdutide Injection, 信尔美
Mazdutide (IBI362) is a weekly GLP-1/glucagon dual agonist with Chinese weight-management and type 2 diabetes approvals. Positive GLORY and US Phase 2 findings must retain their populations, doses and analyses; it is not FDA-approved.
Quick Facts
What is mazdutide?
Mazdutide is an oxyntomodulin-related peptide activating both GLP-1 and glucagon receptors. Innovent Biologics develops the Chinese product under license from Eli Lilly, while the cited US study is Lilly-sponsored. It is injected weekly and is researched for weight and glycemic outcomes.
How does it work?
GLP-1 activity supports glucose-dependent insulin secretion, slower gastric emptying and reduced appetite. Glucagon-receptor activity is intended to increase energy expenditure and reduce liver fat. This second receptor differs from tirzepatide’s GIP target and from semaglutide’s selective GLP-1 action. Receptor count does not establish comparative efficacy, tolerability or each receptor’s contribution in a patient.
Is it FDA-approved?
Mazdutide has no US FDA approval. China’s NMPA approved chronic weight management in 2025; the retrieved 信尔美 label records June 24, 2025. Type 2 diabetes approval followed in September 2025. Those decisions do not establish US availability, an FDA label or approval of every newer research dose.
Sources: [3]
What does the research show?
GLORY-1 randomized 610 Chinese adults with obesity or overweight and comorbidities to weekly 4 mg, 6 mg or placebo over 48 weeks. Treatment-policy weight changes at the primary 32-week assessment were −10.09%, −12.55% and +0.45%, respectively; at 48 weeks they were −11.00%, −14.01% and +0.30%.
GLORY-2 studied 9 mg in Chinese adults with moderate-to-severe obesity: 462 were randomized and 461 treated. At 60 weeks, reported weight change was −16.65% versus −1.50% placebo, broadly about −17% versus −2%. A systematic review found consistent results in predominantly Chinese populations. Replicated positive Phase 3 outcomes support the Chinese approval but are not FDA approval.
US Phase 2 findings and comparison limits
A separate US Phase 2 study randomized 179 adults without type 2 diabetes. At the 32-week primary assessment, efficacy-estimand weight changes were −7.3%, −15.6% and −18.1% in the 3–6, 10 and 16 mg groups versus −0.9% placebo. The 3–6 mg group remained at 3 mg until week 32. These exposures and analyses differ from GLORY-1 and the Chinese label.
Positive weight or biomarker findings do not by themselves establish fewer cardiovascular events, better muscle preservation or superiority to semaglutide, tirzepatide or retatrutide. No matched head-to-head comparison is supplied; indirect comparisons and different ethnic/population characteristics require caution.
Product instructions and trial safety
The retrieved Chinese weight-management label begins at 2 mg weekly, increases to 4 mg after four weeks and permits 6 mg after at least another four weeks when needed; maintenance is 4 or 6 mg. GLORY-2’s 9 mg and the higher US trial doses are separate research exposures, not a generic 8–10 mg prescription.
In GLORY-2, vomiting occurred in 53.1% versus 1.3% placebo, nausea in 46.9% versus 3.2% and diarrhea in 39.4% versus 6.5%; most events were mild or moderate. Adverse-event discontinuation was 2.9% versus 0%. In the US Phase 2 16 mg group it was 20%, mainly GI-related. A 2024 randomized-trial meta-analysis likewise found increased transient mild/moderate GI effects. The Chinese label includes thyroid C-cell warnings and MTC/MEN2 contraindications; absence of a GIP target does not guarantee better tolerability.
References and further reading
This reference draws on Superpower’s Peptide Library and the research linked below. Peptide Dossier’s editorial team adapted and integrated the material on .
- ncbi.nlm.nih.govHow does it work?Cited in: How does it work?
- 10.1001/jama.2026.8142How does it work?Cited in: How does it work?
- 10.1007/s40265-025-02249-yIs it FDA-approved?Cited in: Is it FDA-approved?
- 10.1056/NEJMoa2411528What does the research show?Cited in: What does the research show?
- 10.1111/dom.71058What does the research show?Cited in: What does the research show?
- clinicaltrials.govUS Phase 2 findings and comparison limitsCited in: US Phase 2 findings and comparison limits
- 10.3390/ijms232314631How does it work?Cited in: How does it work?
- 10.1111/dom.15693How does it work?Cited in: How does it work?
- 10.1136/bmj-2026-372161US Phase 2 findings and comparison limitsCited in: US Phase 2 findings and comparison limits
- pubmed.ncbi.nlm.nih.govProduct instructions and trial safetyCited in: Product instructions and trial safety
- 10.3389/fendo.2024.1309118Product instructions and trial safetyCited in: Product instructions and trial safety
- clinicaltrials.gov — additional reading
- img.innoventbio.com — additional reading
- pubmed.ncbi.nlm.nih.gov — additional reading
- pubmed.ncbi.nlm.nih.gov — additional reading
Frequently Asked Questions About Mazdutide
Mazdutide activates GLP-1 and glucagon receptors; retatrutide also targets GIP. Receptor count alone does not establish which treatment is more effective or better tolerated, and cross-trial percentages are not a direct comparison.
A Chinese weight-management product label records June 2025 approval. That is separate from US development and from newer experimental doses. The sources here do not establish a guaranteed US approval or launch date.
The cited GLORY and US trials were placebo-controlled and do not establish direct superiority to semaglutide. Different populations, durations and estimands need to remain attached to the results.
Innovent is associated with the Chinese product and GLORY program; the cited US Phase 2 trial was funded by Eli Lilly. Company names and development rights should not be confused with chemical aliases.
These placebo-controlled trials do not establish direct superiority to tirzepatide. Their positive weight results are meaningful, but a separate matched comparison is required to answer that question.
No. China has approved specified weight-management and type 2 diabetes uses, but those decisions do not establish US approval. The cited US program includes Phase 1/2 research; a US Phase 3 approval program is not established by these sources.
Both include GLP-1 activation, but mazdutide adds glucagon-receptor activity whereas tirzepatide adds GIP-receptor activity. There is no completed direct comparison in the cited evidence, so unmatched trial percentages cannot establish superiority.
The cited evidence does not provide a peer-reviewed head-to-head answer. Indirect network comparisons are hypothesis-generating; Chinese Phase 3 populations and separate US Phase 2 findings should not be treated as a matched comparison.
No FDA-approved mazdutide product or indication is established here. A Chinese approval and a trial result do not provide a US prescribing label.
It adds glucagon-receptor agonism to GLP-1 signaling, with a rationale involving energy expenditure and liver fat as well as appetite and glycemic effects. Whether that gives a particular comparative clinical advantage requires direct outcome evidence.
Nausea, vomiting and diarrhea predominate in trials, generally at mild or moderate severity. Their frequency and treatment discontinuation vary by dose and population; the highest-dose US Phase 2 group had appreciable GI-related discontinuation.
It randomized 610 Chinese adults to weekly 4 mg or 6 mg mazdutide versus placebo for 48 weeks, with a primary 32-week assessment. Both doses produced meaningful weight reductions, supporting the Chinese program; population and analysis limits still matter.
China’s NMPA approved that use in September 2025. This is separate from its earlier Chinese weight-management approval and does not establish FDA approval.
Related Peptides
Continue exploring Mazdutide
- Mazdutide vs Tirzepatide: Chinese GLP-1 Comparison [2026]Comparison
- Mazdutide: China's Dual GLP-1/Glucagon Weight Loss Drug [2026]Guide
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Disclaimer: This article is for informational and educational purposes only. It is not intended as medical advice. The information presented is based on published research and should not be used as a substitute for professional medical guidance. Always consult a qualified healthcare provider before starting any peptide protocol. Some peptides discussed may not be approved for human use by the FDA or equivalent regulatory bodies.