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In clinical trialsMetabolic Research

CagriSema

Also known as: Cagrilintide + semaglutide

An investigational fixed combination of two peptides from Novo Nordisk: cagrilintide, a long-acting amylin analog, and semaglutide, a GLP-1 receptor agonist. It has been studied in several large phase 3 trials (the REDEFINE program).

Evidence: strong · Peer-reviewed phase 3 human data

At a glance

Class
Amylin analog + GLP-1 receptor agonist combination
Developer
Novo Nordisk
FDA status
Investigational. Submitted to the FDA in December 2025 per the developer; no approval confirmed as of October 2026.
Human data
Phase 3 REDEFINE 1 and REDEFINE 2 published in NEJM (2025); REDEFINE 4 topline announced (2026)
Animal / lab data
Mouse receptor work on the cagrilintide component (2025)

Where it’s been studied

123
  • 1Adipose tissue and body weightPhase 3 trials, adults (2025-2026)
  • 2Blood pressureSecondary analysis of REDEFINE 1, adults (2025)
  • 3Brainstem (amylin receptors)Cagrilintide component, knockout mice (2025)

Mechanism studied

CagriSema pairs two receptor targets. Semaglutide activates the GLP-1 receptor, while cagrilintide activates amylin receptors (calcitonin receptors paired with RAMP proteins) [1][2]. In mice, cagrilintide's measured effects on food intake depended on brain amylin receptors 1 and 3 in the area postrema [5]. Whether the two pathways add to each other is the question the combination trials were designed to examine, using separate single-agent arms [1].

What the research shows

StudyModelReported resultSource
REDEFINE 1, phase 3a [1]Human
3,417 adults, randomized 21:3:3:7, double-blind, placebo- and single-agent-controlled, 68 weeks
Coprimary endpoints: change in body weight and proportion reaching 5% or more weight reduction vs placebo. PublishedPeer-reviewed
NEJM 2025
REDEFINE 2, phase 3a [2]Human
1,206 adults with elevated HbA1c, randomized 3:1, double-blind, placebo-controlled, 68 weeks
Coprimary endpoints: change in body weight and proportion reaching 5% or more weight reduction. PublishedPeer-reviewed
NEJM 2025
REDEFINE 1 blood pressure analysis [3]Human
Secondary and post hoc analysis of the 3,417-adult REDEFINE 1 trial
Researchers analyzed change in blood pressure across arms. PublishedPeer-reviewed
Hypertension 2025
REDEFINE 4, phase 3 topline [4]Human
809 adults, randomized, open-label, active comparator (tirzepatide), 84 weeks
Primary endpoint: non-inferiority on body weight vs comparator. Developer reports the primary endpoint was not met; full paper not yet publishedCompany-reported
Company release 2026

Human trials are listed for research context only; outcomes are reported in the linked publications. Animal and lab results do not establish effects in humans.

Supply

PureLab does not supply this compound. This page summarizes published research only.

More in Metabolic Research

Sources

  1. Garvey WT et al. (2025). doi:10.1056/NEJMoa2502081 Source
  2. Davies MJ et al. (2025). doi:10.1056/NEJMoa2502082 Source
  3. Verma S et al. (2025). doi:10.1161/HYPERTENSIONAHA.125.26055 Source
  4. Novo Nordisk A/S (2026) Source
  5. Carvas AO et al. (2025). doi:10.1016/j.ebiom.2025.105836 Source
For research use only. Not for human or veterinary use. Not a drug, food or cosmetic, and not intended to diagnose, treat, cure or prevent any disease. This library summarizes published research for educational purposes. PureLab Performance Inc.