Mazdutide: Mechanism, Research & UK Safety Profile
Also known as: IBI362, LY3305677
Investigational once-weekly GLP-1 / glucagon dual receptor agonist developed by Innovent Biologics (under licence from Eli Lilly). DREAMS phase 3 programme in China for obesity and type 2 diabetes. Not MHRA-licensed in the UK.
Molecular formula
C207H317N45O65
Molecular weight
Approx. 4.5 kDa (~4,476 g/mol)
Half-life
Engineered for once-weekly dosing.
Category
GLP-1 / glucagon dual agonist
Overview
Mazdutide (IBI362) is an investigational long-acting GLP-1 / glucagon dual receptor agonist. The DREAMS phase 3 programme is evaluating mazdutide for obesity (GLORY) and type 2 diabetes (DREAMS-1, DREAMS-2) in China. Regional regulatory pathways differ from MHRA / EMA; mazdutide is investigational in the UK.
Discovery & Research History
Mazdutide originated at Eli Lilly and is being developed by Innovent Biologics under licence in China. Phase 2 data in T2D (Lancet 2023) and the early obesity programme have been reported. The phase 3 programme is mainly anchored in Chinese regulatory submission.
Mechanism of Action
Dual agonism of GLP-1 and glucagon receptors, similar in design rationale to survodutide and pemvidutide.
Researched Effects
- Body-weight reduction in adults with obesity (regional phase 3 data).
- HbA1c reduction in T2D phase 2/3 cohorts.
Theoretical Research Protocols
- Dosage range
- Trial-arm doses are research records.
- Frequency
- Once-weekly subcutaneous administration in trial protocols.
- Duration
- Up to 48-52 weeks in reported designs.
- Administration routes
- Subcutaneous (clinical trial setting)
Safety Profile
Common side effects (research)
- GI events consistent with the dual-agonist class.
- Injection-site reactions.
Rare risks
- Heart-rate increase signal under class monitoring.
- Long-term safety to be characterised.
Contraindications
- Investigational outside regional approval pathway.
- Pregnancy and breastfeeding excluded.
UK Regulatory Status
United Kingdom (MHRA): Investigational. Not MHRA-licensed.
European Union (EMA): Investigational.
Notes: Regional Chinese regulatory approval pathway is distinct from MHRA / EMA / FDA pathways. Mazdutide is not licensed for human therapeutic use in the UK.
Related research resources
Key Research Studies
Ji L et al. Mazdutide for type 2 diabetes — phase 2. Lancet 2023.
Phase 2 trial reporting glycaemic and weight effects of mazdutide in adults with T2D.
Read sourceInnovent DREAMS / GLORY phase 3 programme
Regional phase 3 evaluation in obesity and T2D; refer to current ClinicalTrials.gov / regional registries for status.
Frequently Asked Questions
What is mazdutide?
An investigational GLP-1 / glucagon dual receptor agonist developed by Innovent Biologics in China under licence from Eli Lilly. Phase 3 programmes in obesity and T2D are anchored in the Chinese regulatory pathway.
Is mazdutide licensed in the UK?
No. Mazdutide is investigational outside its regional approval pathway and is not licensed for human therapeutic use in the UK.
Related trials
No published trials yet linked to this page. Source verification required.