Cagrilintide
Cagrilintide is an experimental amylin-based peptide developed to reduce appetite and body weight, studied both alone and combined with semaglutide (CagriSema). Phase 2 monotherapy data and Phase 3 CagriSema data (REDEFINE in obesity, REIMAGINE in type 2 diabetes) report substantial weight reductions. It remains investigational and is not authorized for clinical use.
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)
Related Clinical Trials
- Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse EventsPhase 1 · Recruiting
- A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body WeightPhase 1 · Not Yet Recruiting
- A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or ObesityPhase 1 · Recruiting
- A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or ObesePhase 1 · Recruiting
- Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With CagrilintidePhase 3 · Active Not Recruiting
- Weight Loss in People Living With Overweight or Obesity Following Treatment With CagrilintidePhase 3 · Active Not Recruiting
- A Study on How NNC0174-1213 Works in People With Overweight or Obesity.Phase 1 · Recruiting
- A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy ParticipantsPhase 1 · Completed