CagriSema: Mechanism, Research & UK Safety Profile
Also known as: Cagrilintide + semaglutide combination
Investigational fixed-combination of cagrilintide (amylin analogue) and semaglutide (GLP-1 receptor agonist) under phase 3 evaluation for obesity and type 2 diabetes. Not licensed for human therapeutic use in the UK.
Overview
CagriSema combines the amylin analogue cagrilintide with the GLP-1 receptor agonist semaglutide in a single fixed combination. The integrated mechanism engages two independent pathways implicated in satiety, gastric emptying and glycaemic control. CagriSema is in active phase 3 development across obesity (REDEFINE 1) and type 2 diabetes (REDEFINE 2) populations. It is investigational and not licensed for human therapeutic use in the UK.
Discovery & Research History
CagriSema builds on the established phase 3 evidence base for semaglutide (STEP, SUSTAIN) and the developing evidence base for cagrilintide. The phase 1b combination data established preliminary safety and additive weight effect; the REDEFINE phase 3 programme is testing whether that signal holds at confirmatory scale.
Mechanism of Action
Semaglutide acts on the GLP-1 receptor; cagrilintide acts on amylin / calcitonin receptor signalling. The combined effect on appetite, satiety and gastric emptying is the hypothesised driver of incremental weight reduction beyond semaglutide alone.
Researched Effects
- Body-weight reduction beyond semaglutide alone in phase 1b/2 data.
- Additive engagement of two independent satiety pathways.
- Once-weekly administration in trial protocols.
Theoretical Research Protocols
- Dosage range
- Trial-arm protocols are research records. This page does not provide dosing recommendations.
- Frequency
- Once weekly in pivotal trial protocols.
- Duration
- 68-72 weeks in pivotal trial designs.
- Administration routes
- Subcutaneous (clinical trial setting)
Safety Profile
Common side effects (research)
- GI events consistent with the GLP-1 / amylin class profile.
- Injection-site reactions.
Rare risks
- Severe GI events with dehydration risk.
- Pharmacovigilance for rare events is ongoing as a function of trial reporting.
Contraindications
- Investigational; trial protocol defines eligibility.
- Pregnancy / breastfeeding are typical trial exclusions.
UK Regulatory Status
United Kingdom (MHRA): Investigational. Not MHRA-licensed for any human therapeutic indication.
European Union (EMA): Investigational. Not EMA-licensed at the time of review.
Notes: CagriSema phase 3 readouts are evolving during 2024-2026. Refer to current ClinicalTrials.gov records and the primary publications.
Related research resources
Key Research Studies
Enebo LB et al. Phase 1b CagriSema combination tolerability and weight effect. Lancet 2021.
Initial human combination study reporting additive body-weight reduction with CagriSema versus monotherapy comparators in the studied population.
Read sourceREDEFINE 1 — Phase 3 CagriSema in adults with obesity
Phase 3 obesity trial of CagriSema. Topline readout cycle ongoing during 2024-2026; refer to current ClinicalTrials.gov records and the primary publication for results.
REDEFINE 2 — Phase 3 CagriSema in adults with type 2 diabetes
Phase 3 T2D trial of CagriSema. Topline readout cycle ongoing during 2024-2026.
Frequently Asked Questions
What is CagriSema?
An investigational fixed combination of cagrilintide (amylin analogue) and semaglutide (GLP-1 receptor agonist), in active phase 3 evaluation for obesity and type 2 diabetes.
Is CagriSema licensed in the UK?
No. CagriSema is investigational and is not licensed by the MHRA for any human therapeutic indication.
How does CagriSema differ from semaglutide alone?
CagriSema adds amylin signalling via cagrilintide to the GLP-1 receptor agonism of semaglutide. The combined mechanism is hypothesised to produce greater body-weight reduction than semaglutide alone, with confirmation depending on the phase 3 readouts.
Licensed brand-name medicines
Related trials
No published trials yet linked to this page. Source verification required.