Skip to content

GLP-1s & incretins

Mazdutide

A GLP-1/glucagon dual agonist developed largely in Chinese trial populations.

L4Good human trialsApproved in some countries only · NMPA (China)Approved
How settled this rating is:
moderate confidence in the current evidence rating
Routes studied:
Subcutaneous injection
Also known as:
IBI362, LY3305677, GLP-1/glucagon dual agonist
Last reviewed:
2026-08-23
Jump to section

Evidence passport

Mazdutide

A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.

Reviewed 2026-08-23
Evidence level
L4Good human trials
Confidence
Moderate confidence in rating
Regulatory status
Approved in some countries only · See jurisdiction details
Development status
Approved

Evidence strength

Human efficacy evidence60 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Human safety evidence42 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.

Evidence base
Includes human studies
Furthest established stage
Approved
Human research maturity
Approved in China (2025); development status elsewhere not established
Source curation
Sources fully curated

Routes recorded

SC injection

Overview

Human efficacy evidence strength60 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Preclinical (animal / lab) evidence strength75 of 100 evidence strength

Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.

Human safety evidence strength42 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

How to read these scores

Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.

  • Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
  • Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
  • Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
  • Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
  • Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.

None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.

How far human research has progressed: Approved in China (2025); development status elsewhere not established

Routes & formulations

Studied / approved routes

SC injection

Approved products in China are subcutaneous injections; trial programmes elsewhere use the same route.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

Reached regulatory approval in China in 2025 for two indications. Development and approval status outside China is not established in our curated record.

Last documented development: 2025 — NMPA approvals (weight management, June; type 2 diabetes, September)

What it is

An oxyntomodulin-based dual agonist combining appetite suppression with glucagon-driven energy expenditure.

What people claim

  • Meaningful weight loss
  • Liver fat reduction

What the evidence actually says

Human randomised data are encouraging, with weight and hepatic fat effects. Generalisability across populations and long-term safety are the open questions, not whether it does something.

Useful next reads based on this compound — not recommendations.

Human evidence

  • Randomised controlled trials in obesity and type 2 diabetes, largely in Chinese populations.

Preclinical evidence

  • Oxyntomodulin analogue pharmacology and rodent metabolic models.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • GLP-1 arm suppresses appetite.
  • Glucagon arm increases energy expenditure and hepatic lipid turnover.

Safety and unknowns

  • Class-typical gastrointestinal effects; glucagon-related metabolic monitoring required.

Cancer relevance

This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.

No established human signal

No established human cancer signal; class-level surveillance applies.

Regulatory status

Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.

Named regulators: NMPA (China)

Approved in China by the NMPA: for chronic weight management in June 2025, and for glycaemic control in adults with type 2 diabetes in September 2025. Not approved in the US, UK or EU — a regional approval, not a global one.

  • 2025-06 · China

    NMPA approved mazdutide for chronic weight management. A regional approval; not approved in the US, UK or EU.

  • 2025-09 · China

    NMPA approved mazdutide for glycaemic control in adults with type 2 diabetes, its second Chinese indication.

Evidence grade

L4Good human trialsModerate confidence in rating

Completed, adequately informative controlled human trials supporting a specified outcome; replication and longer-term safety may remain uncertain.

What would change our rating?

  • Multi-region Phase 3 data.
  • Approval decisions outside the initial development region.

References and sources

Source transparency

A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.

Sources fully curated
Last editorial review
2026-08-23
Recently reviewed · 54 days ago
Linked curated sources
0
Sources still pending
0
External specialist reviews
0
None recorded for this profile
Sponsor / official: 2

Review provenance

Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.

Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.

  • Sponsor / officialInnovent Biologics announcement — NMPA approval of mazdutide for chronic weight management (June 2025)
  • Sponsor / officialInnovent Biologics announcement — NMPA approval of mazdutide for type 2 diabetes (September 2025)

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

These entries record changes to our assessment of the published evidence — not changes to the compound itself.

No recorded changes yet. Baseline position set on 2026-08-23.