Cagrilintide

Mechanism

In plain terms, cagrilintide mimics amylin, a hormone released with insulin that promotes fullness and slows digestion. Technically, it is a long-acting amylin analogue that agonizes amylin and calcitonin family receptors, reducing food intake, slowing gastric emptying, and enhancing satiety through central and peripheral pathways. Its mechanism is complementary to GLP-1 receptor agonism, which is the rationale for combining it with semaglutide in CagriSema.

Regulatory Status by Region

• United States (FDA)Investigational; not approved as a standalone product. As part of the CagriSema combination (with semaglutide), a new drug application has been filed and an FDA decision is expected later in 2026.
• Australia (TGA)Not entered on the ARTG; investigational only and not approved for supply.
• European Union (EMA)Not authorized; investigational, no marketing authorization.
• WADANot listed on the WADA Prohibited List. Amylin analogues are not banned substances; as an investigational agent it falls outside approved therapeutic use.

Key Studies

• Once-weekly cagrilintide for weight management in people with overweight and obesity: a dose-finding phase 2 trial (Lau et al.) (Lancet 2021;398:2160-2172; DOI 10.1016/S0140-6736(21)01751-7; PMID 34798060)
• Safety, tolerability, pharmacokinetics of concomitant cagrilintide and semaglutide (Phase 1b; Enebo et al.) (Lancet 2021;397:1736-1748; DOI 10.1016/S0140-6736(21)00845-X; PMID 33894838)
• A Research Study of How Well CagriSema Works in People Living With Overweight or Obesity (REDEFINE 1, Phase 3) (ClinicalTrials.gov NCT05567796)