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Research profile · Peptide analogue

Cagrilintide

Also known as AM833, NNC0174-0833, Long-acting amylin analogue

Early human — evidence level 3 of 4: Early human evidenceExperimental — UK regulatory status: Experimental — not authorised for human use in the UK

Overview

An investigational analogue of the pancreatic hormone amylin studied for its activity at amylin and calcitonin receptors.

Category
Peptide analogue
Highest evidence level identified
Early human evidence
Last scientifically reviewed
19 August 2026
Last regulatory review
19 August 2026

Mechanism under investigation

Cagrilintide is a long-acting synthetic analogue of human amylin, a 37-amino-acid pancreatic hormone co-secreted with insulin, modified with a fatty-acid side chain that extends its half-life. It is described as a dual amylin and calcitonin receptor agonist, engaging amylin receptors — heterodimers of the calcitonin receptor with receptor activity-modifying proteins — as well as the calcitonin receptor itself. It acts on a receptor system distinct from that of the incretin-based compounds.

Research areas

  • Metabolic research
  • Amylin signalling

These are fields in which the compound has been investigated. Listing a field is not a statement that anything was demonstrated within it.

Current evidence

In-vitro evidence

Cells, tissues or biochemical systems outside a living organism.

Published receptor pharmacology characterises the balance of activation across amylin and calcitonin receptors, including signalling assays in cell lines expressing primate, rat and mouse receptor variants, and comparison against other dual amylin and calcitonin receptor agonists.

Animal evidence

Studies in living non-human animals.

An independent preclinical literature exists. Work in mice lacking specific receptor activity-modifying proteins established receptor dependency: reductions in body weight and fat mass with preservation of lean mass were observed in wild-type animals but absent in knockouts, and hindbrain neuronal activation was correspondingly attenuated. Separate rodent work used high-fat-diet obese and Zucker diabetic fatty rat models.

Human observational evidence

Studies observing people without assigning an intervention.

No substantial published work exists at this level. Cagrilintide is not authorised in any jurisdiction and cannot be prescribed, so there is no routine-care cohort to observe. All human data come from sponsor-run interventional trials.

Clinical-trial evidence

Studies assigning an intervention to human participants.

As a single agent the peer-reviewed evidence reaches phase 2: a 26-week multicentre randomised double-blind dose-finding trial across ten countries including the UK, in adults with overweight or obesity without type 2 diabetes, preceded by a phase 1b combination study. Phase 3 evidence relates chiefly to a fixed-dose combination with semaglutide rather than to cagrilintide alone, so effects attributable to this compound by itself cannot be isolated from it.

Study limitations

  • Most phase 3 evidence tests cagrilintide in combination with semaglutide, so effects attributable to cagrilintide alone cannot be separated from that data.
  • The standalone peer-reviewed human evidence rests largely on a single 26-week dose-finding trial — short in duration and not powered for clinical outcomes.
  • No observational, real-world or post-marketing data exist, so rare adverse events and long-term effects are entirely uncharacterised.
  • Amylin-receptor pharmacology is less mature than incretin pharmacology, and the long-term consequences of sustained amylin and calcitonin receptor agonism in humans are not established.

UK regulatory context

Experimental — not authorised for human use in the UK

A compound appearing in research literature that holds no UK authorisation for human use in any indication.

Source: Search of the electronic Medicines Compendium for cagrilintide (opens medicines.org.uk in a new tab) (electronic Medicines Compendium)

Regulatory classification is jurisdiction-specific. A compound authorised elsewhere is not thereby authorised in the UK, and a supplier’s description of a substance does not determine how it is classified in law. See safety and regulation for the framework and the authoritative sources.

Safety and interpretation

In the published phase 2 monotherapy literature cagrilintide was reported as tolerated over 26 weeks, with gastrointestinal effects the most commonly reported adverse events — a pattern shared with, though mechanistically distinct from, the incretin-based compounds. Because no regulator has completed an assessment and no post-marketing surveillance exists anywhere, this characterisation is preliminary and derives entirely from selected trial populations. Sponsor-run trials examining bone metabolism and muscle health are ongoing, which indicates that some organ-system effects remain open questions.

References