P Palthera
Hormone Analogues

Mazdutide

IBI362 / LY3305677

Mazdutide (IBI362, originally LY3305677) is a once-weekly dual GLP-1 / glucagon . Originally developed by Eli Lilly and now advanced by Innovent Biologics, mazdutide is most extensively studied in Chinese populations. It has received conditional approval in China for chronic weight management; international regulatory approvals are not yet in place at the time of writing.

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Hormone Analogues
Classification
Dual GLP-1 / glucagon receptor agonist · Conditionally approved in China; investigational elsewhere
Research stage
Phase III evidence published in Chinese adults with obesity; conditionally approved in China for chronic weight management
Sequence
Long-acting dual-agonist peptide based on oxyntomodulin / GLP-1 scaffolds
Molecular weight
Approx. 4400 Da

Snapshot

Key takeaways

A three-bullet snapshot before reading the full dossier.

  1. 01

    Dual GLP-1 + glucagon designed for once-weekly subcutaneous dosing.

  2. 02

    Conditionally approved in China for chronic weight management; investigational elsewhere.

  3. 03

    Primary clinical evidence is from Phase 1b and Phase 3 trials in Chinese adults with overweight or obesity.

Dossier overview

4

research areas

3

references

3

handling notes

01

Mechanism of action

Mazdutide activates GLP-1 and glucagon . The combined activity is associated with weight reduction (via appetite suppression and energy expenditure) and improved glycaemic control in clinical-trial research.

02

Research applications

  • Obesity clinical research (predominantly Chinese populations)
  • Type 2 diabetes clinical research
  • Dual- incretin pharmacology
  • Glucagon- metabolic research

Evidence at a glance

What's behind this profile

3 citations · 2021–2025

Human
3

Studies in human volunteers or patients (incl. early-phase trials).

Publication years

  1. 21
  2. 22
  3. 23
  4. 24
  5. 25
20212025

Counts are derived from the cited studies below. A study covering both in vivo and in vitro work is counted by its primary model. Sample size is reported in 3 of 3 citations. Findings remain model-specific and are not extrapolated to therapeutic use.

03

Study references

Each profile cites a minimum of two peer-reviewed sources, with model type and reported sample size where the source provides it. Findings are model-specific and must not be extrapolated to therapeutic use.

IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity

2021

Ji L et al. · EClinicalMedicine

Model
Phase 1b randomised placebo-controlled multiple-ascending-dose trial in Chinese adults
Sample
n=36

Mazdutide was associated with body-weight reductions up to 6.4% with primarily gastrointestinal adverse events in the dose-escalation cohort.

PMID 34430840 DOI 10.1016/j.eclinm.2021.101088

Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity

2022

Ji L et al. · EClinicalMedicine

Model
Phase 1b randomised placebo-controlled multiple-ascending-dose trial (higher doses)
Sample
n=24

Higher-dose mazdutide (9–10 mg) was associated with body-weight reductions up to 11.7% in the cohort of Chinese adults with overweight or obesity.

PMID 36247927 DOI 10.1016/j.eclinm.2022.101691

Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight

2025

Ji L et al. · New England Journal of Medicine

Model
Phase 3 double-blind placebo-controlled RCT in Chinese adults with obesity or overweight
Sample
n=610

Mazdutide was associated with dose-dependent body-weight reductions up to 14.01% versus placebo with favourable cardiometabolic effects in the Chinese-population trial.

PMID 40421736 DOI 10.1056/NEJMoa2411528

Evidence caveats

  • Regulatory status varies by jurisdiction. Mazdutide is conditionally approved in China but is not FDA-approved (US) or EMA-approved (EU) at the time of writing.
  • All primary published trials enrolled Chinese populations; generalisability to non-Asian populations is not established in the cited literature.

04

Storage and handling

Approved product (in China) follows manufacturer cold-chain instructions. Research-grade material must be stored under controlled laboratory conditions per protocol.

  • Approved product (in China) follows the manufacturer label.
  • Research-grade material requires controlled laboratory storage and full batch traceability.
  • Investigational outside the approved jurisdiction; clinical decisions require a qualified healthcare professional.

Common questions

Mazdutide FAQ

Plain-English answers backed by the citations on this profile — what it is, what's been studied, regulatory status, evidence limits.

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