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Cagrilintide

Cagrilintide (AM833) is a novel long-acting lipidated amylin analog that acts as a dual amylin and calcitonin receptor agonist.

Cagrilintide molecular structure

Overview

Cagrilintide (AM833) is a novel long-acting lipidated amylin analog that acts as a dual amylin and calcitonin receptor agonist. Developed for weight management and type 2 diabetes treatment, it shows superior weight loss potential when combined with semaglutide (CagriSema), with recent Phase 3 trials demonstrating up to 22.7% weight reduction.

Last reviewed: 2026-08-18

Identity & Aliases

Also known as

amylin analoguelong-acting amylin receptor agonistCagriSema (co-administered with semaglutide)

Status: Investigational - FDA development candidate with Phase 3 data; FDA approval expected Q1 2026

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

3 studies
Clinical2025

CagriSema (cagrilintide + semaglutide) achieved approximately 22.7% mean weight loss at 68 weeks, superior to semaglutide monotherapy, in adults with overweight or obesity.

Phase 3 REDEFINE 1 trial (NEJM)
Preclinical2025

Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3 in preclinical models.

preclinical study (Lancet eBioMedicine)

Benefits & Effects

4 documented

FDA development candidate

clinical

extensive Phase 3 data

clinical

superior weight loss in combination with semaglutide

clinical

once-weekly convenience

clinical

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).

Reported Research Dosing

Reported values from research literature and community protocols. Educational reference only — not a dosing recommendation or medical advice.

2.4 mg weekly

Route: Injectable
Half-life: 7.5 days

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

Compare CagrilintideSide-by-side vs another peptidePeptide Tier ListRanked by research depthBrowse PeptidesBrowse the full peptide database

Quick Facts

Molecular Weight

4409.01

Mechanism

Subcutaneous injection provides optimal bioavailability of lipidated amylin analog, targeting dual amylin and calcitonin receptors for satiety and metabolic effects

Safety Information

Most common side effects are gastrointestinal (nausea, vomiting, diarrhea) during initial weeks. Anti-cagrilintide antibodies develop in 46-73% of patients but do not affect efficacy. No clinically significant QT prolongation observed in thorough QT studies. Only 57.3% of patients achieved maximum 2.4 mg dose in REDEFINE 1 trial. Formulation must be maintained at acidic pH (3.5-4.5) to prevent fibril formation and deamidation. Reconstituted solutions should be inspected for cloudiness or particles before each use.

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