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GLP-1s & incretins

Mazdutide

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

L4Strong humanApproved — specific region(s)ApprovedModerate confidenceLast reviewed 2026-08-23
SC injection

Also known as: IBI362, LY3305677, GLP-1/glucagon dual agonist

Evidence passport

Last reviewed 2026-08-23

Evidence level
L4Strong human
Confidence
Moderate confidence
Human efficacy
60/100
Human safety
42/100
Regulatory status
Approved — specific region(s)
Development
Approved
Routes
SC injection
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Approved in China (2025); development status elsewhere not established

Overview

Human evidence60/100
Preclinical evidence75/100
Human safety evidence42/100

Clinical maturity: 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.

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

No established human signal

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

Regulatory status

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

L4Strong humanModerate confidence

Solid controlled human trials, though not yet definitive or fully replicated.

What would change our rating?

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

References and sources

Sources fully curated
  • 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

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