Clinical2021
Once-weekly cagrilintide produced dose-dependent weight loss over 26 weeks in adults with overweight/obesity in a placebo- and active-controlled dose-finding phase 2 trial.
0 views
Cagrilintide
Long-acting amylin analog for appetite control and weight management
Overview
Cagrilintide is a long-acting amylin analog developed by Novo Nordisk. Amylin is a hormone co-secreted with insulin that promotes satiety and slows gastric emptying. Cagrilintide is being studied in combination with semaglutide (CagriSema) for enhanced weight loss effects. Clinical trials show promising results for obesity treatment.
Last reviewed: 2026-08-18
Identity & Aliases
Also known as
amylin analoguelong-acting amylin receptor agonistCagriSema (co-administered with semaglutide)
Status: phase_3
Full composition (formula, molecular weight, sequence) in Quick Facts →
Research Areas
Obesity and weight managementType 2 diabetesMetabolic disease
Available Evidence
Human
A 2021 phase 2 dose-finding trial (Lancet) showed once-weekly cagrilintide produced dose-dependent weight loss in adults with overweight or obesity. In the phase 3 REDEFINE 1 trial (NEJM 2025), co-administered cagrilintide plus semaglutide (CagriSema) achieved about 22.7% mean weight loss at 68 weeks versus roughly 16.1% with semaglutide alone; REDEFINE 2 reported similar benefits in people with type 2 diabetes. As of mid-2026 cagrilintide was not yet FDA-approved.
Animal
Preclinical studies show cagrilintide reduces food intake and body weight in rodent models of obesity. A 2025 Lancet eBioMedicine study showed its weight-lowering effects are mediated through brain amylin receptors 1 and 3.
In Vitro
Receptor pharmacology studies characterize cagrilintide as a potent, long-acting agonist at amylin receptors (calcitonin-receptor-based AMY1-3), with a prolonged receptor-binding profile.
Key Studies & Findings
Clinical2025
CagriSema (cagrilintide + semaglutide) achieved approximately 22.7% mean weight loss at 68 weeks, superior to semaglutide monotherapy, in adults with overweight or obesity.
Preclinical2025
Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3 in preclinical models.
preclinical study (Lancet eBioMedicine)
No benefits data available yet.
Check back later for updates.
No side effects data available yet.
This peptide may have limited safety data.
Limitations & Open Questions
The phase 2 program was dose-finding and not powered for long-term efficacy or safety. REDEFINE 1 missed its pre-specified ~25% weight-loss expectation. Gastrointestinal side effects (nausea, vomiting, diarrhea) are common. Long-term cardiovascular outcomes have not yet been reported, and regulatory approval was still pending as of mid-2026.
Pharmacology
Once-weekly subcutaneous dosing supported by a long plasma half-life (approximately 168-192 hours, 7-8 days). Mechanism: amylin receptor agonism (brain AMY1/AMY3) that reduces food intake, with additive weight loss when combined with semaglutide (CagriSema).
Research Protocols
Weight Loss (Monotherapy)
- Dose
- 2.4 mg weekly
- Frequency
- Once weekly
- Route
- Subcutaneous injection
Weight Loss (CagriSema)
- Dose
- 2.4 mg + semaglutide 2.4 mg
- Frequency
- Once weekly
- Route
- Subcutaneous injection
Type 2 Diabetes Management
- Dose
- 2.4 mg weekly
- Frequency
- Once weekly
- Route
- Subcutaneous injection with metformin
Dose Escalation Protocol
- Dose
- 0.25 mg → 0.5 mg → 1.0 mg → 1.7 mg → 2.4 mg
- Frequency
- Weekly increases over 16 weeks
- Route
- Subcutaneous injection
Combination Diabetes Therapy
- Dose
- 2.4 mg + SGLT2 inhibitor
- Frequency
- Once weekly
- Route
- Subcutaneous injection
Cardiovascular Risk Reduction
- Dose
- 2.4 mg weekly
- Frequency
- Once weekly
- Route
- Subcutaneous injection (REDEFINE 3 trial)
Research protocols are for educational purposes only. Always consult qualified medical professionals.
Frequently Asked Questions
Is cagrilintide FDA-approved?
Not as of mid-2026. It has completed phase 2 and phase 3 trials (including CagriSema combination studies) and regulatory review was ongoing.
What is CagriSema?
CagriSema is the co-administration of cagrilintide (a long-acting amylin analogue) and semaglutide (a GLP-1 receptor agonist), studied in the phase 3 REDEFINE program for obesity and type 2 diabetes.
How does cagrilintide differ from GLP-1 drugs?
It targets the amylin pathway rather than GLP-1. Amylin receptor agonism reduces appetite and slows gastric emptying through a distinct mechanism, which is why the combination with a GLP-1 agonist produces additive weight loss.
Research Citations
1
REDEFINE 1 Trial - Phase 3 Weight Loss (2025)
(2025)
2
REDEFINE 2 Trial - Phase 3 Type 2 Diabetes (2025)
(2025)
3
Thorough QT Study - Cardiac Safety (2024)
(2024)
Related Resources
Quick Facts
Mechanism
Amylin receptor agonist - activates amylin receptors to reduce appetite, slow gastric emptying, and improve glycemic control
Citations
31.REDEFINE 1 Trial - Phase 3 Weight Loss (2025)
(2025)
2.REDEFINE 2 Trial - Phase 3 Type 2 Diabetes (2025)
(2025)
3.Thorough QT Study - Cardiac Safety (2024)
(2024)