Guides · PeptideU · 8 min read

What Is Mazdutide Used For? Approved Uses and the Trials Behind Them

The short answer

Mazdutide is a prescription medicine approved in China for long-term weight management and an investigational medicine elsewhere, including the United States, where no FDA-approved prescribing information exists. The first-approval review describes the weight-management indication, supported by a 48-week phase 3 trial in Chinese adults with obesity or overweight. Phase 3 trials in type 2 diabetes compared mazdutide with placebo and with dulaglutide. Any question about personal use belongs with a prescribing clinician.

Mazdutide is a prescription medicine approved in China for long-term weight management, and it remains an investigational medicine in the United States and other regions where regulators have not approved it and no US prescribing information exists. That distinction matters for a page about approved uses: an indication is a sentence a regulator signed off on for a specific product in a specific country, and outside China the mazdutide indications described below have regulatory standing only in the jurisdiction that granted them. A first-approval review in Drugs summarised the approval and the development programme behind it (PMID 41028652).

Related overview: Mazdutide.

What Mazdutide Is, in Pharmacological Terms

Mazdutide, also identified in early trial reports as IBI362, was described as a dual agonist at the glucagon-like peptide-1 (GLP-1) receptor and the glucagon receptor in a phase 1b multiple-ascending-dose trial in Chinese adults with overweight or obesity that evaluated 9 mg and 10 mg (PMID 36247927). A review of emerging obesity pharmacotherapies placed mazdutide within the broader class of incretin-based and multi-receptor agonist agents under development (PMID 39952695), and an endocrine review of novel GLP-1-based medications for type 2 diabetes and obesity covered the same mechanistic family (PMID 41054801).

The Approved Indication

The Drugs first-approval review reported that mazdutide received its first approval in China in 2025 for long-term weight management in adults with obesity, or with overweight accompanied by at least one weight-related condition, used together with a reduced-calorie diet and increased physical activity (PMID 41028652). That review also described continuing development of mazdutide for type 2 diabetes and other indications (PMID 41028652).

No United States prescribing information for mazdutide exists at the time of writing, so there is no US label wording to quote and no US product name, revision year or boxed-warning text to reproduce. Clinicians and regulators in markets without an approval treat mazdutide as an investigational agent studied in clinical trials, a status the published reviews reflect when they group it with agents in late-stage development (PMID 39952695).

Indication Summary Table

Use	Regulatory standing	Key published trials
Long-term weight management in adults with obesity or overweight with a weight-related condition	Approved in China, 2025, as described in the first-approval review (PMID 41028652)	Phase 3 in Chinese adults with obesity or overweight (PMID 40421736); phase 2 (PMID 38092790)
Glycaemic control in type 2 diabetes	Development programme described in the first-approval review (PMID 41028652)	Phase 3 versus placebo (PMID 41407859); phase 3 versus dulaglutide (PMID 41407860); phase 2 (PMID 37943529)

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Trials Behind the Weight-Management Indication

Phase 3 in adults with obesity or overweight

A phase 3 randomised trial published in The New England Journal of Medicine studied once-weekly mazdutide at 4 mg and 6 mg against placebo in Chinese adults with obesity or overweight over 48 weeks, and the researchers reported greater reductions in body weight in both mazdutide groups than in the placebo group at week 48 (PMID 40421736). The study also reported that gastrointestinal adverse events were the most frequently observed events with mazdutide and were generally mild or moderate (PMID 40421736).

Phase 2 dose-ranging in overweight adults and adults with obesity

An earlier phase 2 randomised controlled trial in Chinese overweight adults or adults with obesity evaluated mazdutide at 3 mg, 4.5 mg and 6 mg once weekly against placebo over 24 weeks, and researchers reported dose-related reductions in body weight compared with placebo (PMID 38092790). The phase 1b multiple-ascending-dose trial that preceded it examined 9 mg and 10 mg in Chinese adults with overweight or obesity and reported on safety, tolerability and weight change at those higher doses (PMID 36247927).

Pooled analysis across trials

A systematic review and meta-analysis of randomised controlled trials pooled weight outcomes for mazdutide across participants with and without diabetes and reported greater weight reduction with mazdutide than with placebo, alongside a higher frequency of gastrointestinal adverse events (PMID 38440786).

Trials in Type 2 Diabetes

Two phase 3 trials published in Nature addressed glycaemic control. The first compared mazdutide with placebo in Chinese adults with type 2 diabetes and researchers reported greater reductions in glycated haemoglobin with mazdutide than with placebo (PMID 41407859). The second compared mazdutide with dulaglutide in Chinese adults with type 2 diabetes, an active-comparator design that reported on glycaemic and body-weight outcomes between the two agents (PMID 41407860).

The supporting phase 2 work was a randomised, double-blind, placebo-controlled trial in Chinese patients with type 2 diabetes that tested mazdutide at 3 mg, 4.5 mg and 6 mg once weekly and reported reductions in glycated haemoglobin and body weight relative to placebo (PMID 37943529). Reviews of GLP-1-based medications for type 2 diabetes and obesity have summarised these programmes within the wider comparative landscape (PMID 41054801).

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Regulatory History of the Indications

Early-phase evaluation. A phase 1b multiple-ascending-dose trial of 9 mg and 10 mg in Chinese adults with overweight or obesity characterised safety and preliminary efficacy (PMID 36247927).
Phase 2 dose selection. Randomised phase 2 trials in overweight adults and adults with obesity (PMID 38092790) and in patients with type 2 diabetes (PMID 37943529) tested 3 mg, 4.5 mg and 6 mg once weekly.
Phase 3 confirmation in weight management. A 48-week placebo-controlled trial of 4 mg and 6 mg once weekly supported the weight-management programme (PMID 40421736).
First approval. The first-approval review reported approval in China in 2025 for long-term weight management in adults with obesity or overweight with a weight-related condition (PMID 41028652).
Diabetes programme. Phase 3 results versus placebo (PMID 41407859) and versus dulaglutide (PMID 41407860) were published for Chinese adults with type 2 diabetes.

A review of obesity in China set this sequence in its public-health context, describing the scale of obesity there and the development of domestically studied pharmacotherapies (PMID 41389801).

Uses Beyond the Approved Indication

One short factual note belongs here. Any application of mazdutide outside the approved weight-management indication in China, including compounded preparations and uses explored in ongoing research, is not an approved use anywhere at present, and published reviews describe such applications as investigational rather than established (PMID 39952695). A broader review of obesity medications discussed multisystem outcomes reported across this drug class and noted that evidence varies considerably by agent and by outcome (PMID 42208956). Whether any of that literature applies to an individual is a question for a prescribing clinician, not for a web page.

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Mazdutide Tolerability: What Studies Report

Across the published programme, the most commonly reported adverse events were gastrointestinal. The phase 3 weight-management trial reported that gastrointestinal events such as nausea, diarrhoea and vomiting occurred more often with mazdutide than with placebo and were mostly mild to moderate in severity (PMID 40421736). The pooled meta-analysis across randomised trials likewise reported a higher incidence of gastrointestinal adverse events with mazdutide compared with placebo (PMID 38440786). The phase 2 trial in patients with type 2 diabetes reported that treatment-emergent adverse events were predominantly gastrointestinal and generally mild or moderate (PMID 37943529), and the phase 1b trial at 9 mg and 10 mg reported safety and tolerability findings at those higher exposures (PMID 36247927).

Approved labelling in any jurisdiction carries contraindications, warnings and monitoring instructions that no summary of trial abstracts can replace. A prescribing clinician works from the current approved labelling for the specific product in the specific country, together with the individual's medical history.

How to Read Country-Specific Approvals

Three points recur in the literature and are worth keeping straight.

Approval is jurisdictional. The first-approval review documented approval in China and did not describe approvals elsewhere (PMID 41028652).
Trial populations shape indications. The pivotal weight-management and diabetes trials enrolled Chinese adults (PMID 40421736, PMID 41407859), a point the review of obesity in China discussed when describing regional evidence (PMID 41389801).
Class evidence is not product evidence. Reviews covering incretin-based agents as a class describe outcomes studied with several different molecules (PMID 41054801, PMID 42208956), and those findings do not automatically transfer to mazdutide's approved wording.

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Questions That Belong With a Prescribing Clinician

Whether a given indication applies to a particular person, how an approved product is labelled in a particular country, what monitoring is appropriate, and how any medicine interacts with existing conditions and prescriptions are clinical judgements. This page is for educational purposes only and is not medical advice; consult a licensed physician or other qualified healthcare professional about any medicine, including mazdutide, and about any personal health decision.

References

Frequently asked questions

What is mazdutide approved for?▾

A first-approval review reported that mazdutide received approval in China in 2025 for long-term weight management in adults with obesity, or overweight with at least one weight-related condition, used with a reduced-calorie diet and increased physical activity (PMID 41028652). Approvals are country-specific, and the review did not describe approvals in other jurisdictions. Questions about personal suitability belong with a prescribing clinician.

Does mazdutide have a United States prescribing information?▾

No United States label exists at present, so there is no US product name, revision year or approved indication wording to quote. In the United States, mazdutide has been studied as an investigational medicine within the development programme summarised by published reviews of emerging obesity pharmacotherapies (PMID 39952695) and GLP-1-based medications (PMID 41054801).

Which trial supported the weight-management indication?▾

A phase 3 randomised trial published in 2025 tested once-weekly mazdutide at 4 mg and 6 mg against placebo in Chinese adults with obesity or overweight over 48 weeks, and researchers reported greater body-weight reduction with both doses than with placebo (PMID 40421736). An earlier phase 2 trial evaluated 3 mg, 4.5 mg and 6 mg over 24 weeks (PMID 38092790).

What do the type 2 diabetes trials show?▾

A phase 3 trial reported greater reductions in glycated haemoglobin with mazdutide than with placebo in Chinese adults with type 2 diabetes (PMID 41407859), and a second phase 3 trial compared mazdutide with dulaglutide in the same population (PMID 41407860). A phase 2 trial testing 3 mg, 4.5 mg and 6 mg reported reductions in glycated haemoglobin and body weight versus placebo (PMID 37943529).

How does mazdutide work?▾

Published trial reports described mazdutide, also identified as IBI362, as a dual agonist at the glucagon-like peptide-1 receptor and the glucagon receptor, evaluated at 9 mg and 10 mg in an early multiple-ascending-dose study (PMID 36247927). Reviews of incretin-based therapies group it with multi-receptor agonists studied for obesity and type 2 diabetes (PMID 41054801).

What adverse events did the studies report?▾

The phase 3 weight-management trial reported gastrointestinal events including nausea, diarrhoea and vomiting as the most common, mostly mild to moderate (PMID 40421736). A meta-analysis of randomised trials reported more gastrointestinal adverse events with mazdutide than placebo (PMID 38440786). Approved labelling carries the full warnings and contraindications, and a prescribing clinician interprets them individually.

Are there uses of mazdutide outside the approved indication?▾

Applications outside the approved weight-management indication in China, including compounded preparations and outcomes explored in ongoing research, are not approved uses anywhere at present and are described in the literature as investigational (PMID 39952695). A broader review noted that multisystem outcomes reported for obesity medications vary by agent and by outcome (PMID 42208956).

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References

Keep learning

18+ · Educational purposes only
This page summarises published research for education — it is not medical advice, and nothing here is a recommendation to use, purchase, or dose any substance. Study parameters described are what researchers reported, not instructions. Consult a qualified clinician before any health decision.