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In clinical trials

Digestive & weight

Cagrilintide

EvidenceModerate research
ClassLong-acting amylin analog

Cagrilintide is an investigational long-acting amylin analog from Novo Nordisk. Learn how it works, what trials show, and why it is not approved on its own.

Reviewed by
William Maish, MD MBA MPH, Clinical Product Lead
Published
April 18, 2026
Last updated
October 5, 2026

Key takeaway

Cagrilintide is an investigational long-acting amylin analog, developed by Novo Nordisk as a once-weekly injection for weight management. In a Phase 2 trial, it produced weight loss over 26 weeks, but most of its late-stage development is as the amylin component of the combination drug CagriSema, though a standalone Phase 3 trial has started. As of 2026, cagrilintide is not approved on its own.

At a glance

FDA statusInvestigational peptide, not approved by the FDA or any regulator
What it isLong-acting amylin analog given as a once-weekly injection
ResearchStandalone human evidence is a single Phase 2 trial in overweight and obesity
DevelopmentLargely moved to the combination product CagriSema
Evidence strengthModerate research

What is cagrilintide?

Cagrilintide is an experimental drug that mimics amylin, a hormone the pancreas releases alongside insulin that signals fullness. It was engineered by Novo Nordisk to last long enough for once-weekly injection and has been studied for weight management. It is investigational and not approved for any use, and much of its development now centers on pairing it with semaglutide in the combination CagriSema. Cagrilintide’s development codes are AM833 and NNC0174-0833.

How does it work?

Cagrilintide acts at amylin and calcitonin receptors1, mimicking the natural hormone amylin. Activating these receptors is associated with three effects, which together reduce food intake:

  • Greater satiety
  • Slower stomach emptying
  • Suppression of glucagon after meals

Because this is a different pathway from the GLP-1 incretin system2, cagrilintide is also studied in combination3 with GLP-1 drugs on the theory that the two mechanisms complement each other. This describes the proposed mechanism rather than a proven outcome.

Is it FDA-approved?

No. Cagrilintide is investigational and not approved by the FDA or any other regulator. Most of its late-stage development is as part of CagriSema, though Novo Nordisk has also started a standalone Phase 3 trial4 of cagrilintide alone.

What does the research show?

The main standalone evidence is one Phase 2 trial. According to PubMed, a 26-week dose-finding trial1 in people with overweight or obesity without diabetes reported weight reductions across a range of doses compared with placebo, with gastrointestinal effects as the most common side effect. This is a single, limited Phase 2 study; cagrilintide alone has not completed a Phase 3 trial for obesity, so its standalone efficacy and long-term profile are not established.

More for digestive & weight

Sources: the Phase 2 dose-finding trial of cagrilintide (Lau et al., The Lancet, 2021, DOI: 10.1016/S0140-6736(21)01751-71), indexed on PubMed. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.