Cagrilintide
Cagrilintide is an investigational long-acting amylin analog from Novo Nordisk that is not yet FDA-approved as a standalone drug; it is furthest along in development combined with semaglutide as CagriSema, for which an FDA new drug application was submitted in December 2025 with a regulatory decision anticipated in late 2026, while cagrilintide monotherapy is advancing into a dedicated Phase 3 program.
This page is a research-orientation summary, not a dosing guide. For anything beyond general background, read the primary literature or talk to a qualified clinician — specifics like amount, frequency, or administration aren't something we publish here.
What it does & how it works
Cagrilintide is a synthetic analog of human amylin, a hormone co-secreted with insulin by pancreatic beta cells, modified with a fatty-diacid side chain for albumin binding and an extended half-life. It activates amylin receptors in the area postrema and other hindbrain and hypothalamic centers involved in satiety, distinct from but complementary to GLP-1 receptor signaling, slowing gastric emptying and reducing food intake. When combined with a GLP-1 receptor agonist such as semaglutide, the two complementary satiety pathways are thought to produce additive or synergistic appetite suppression and weight loss.
Typical results seen in research
In the Phase 3 REDEFINE 1 trial, cagrilintide used as monotherapy produced average weight loss of about 11.8% over 68 weeks versus roughly 2.3% with placebo, with roughly a third of participants achieving 15% or greater weight loss. When co-administered with semaglutide as CagriSema, Phase 3 REDEFINE trials have reported larger average weight reductions than either agent alone, though CagriSema itself remains investigational and not yet FDA-approved.
How it’s commonly used
In clinical trials, cagrilintide (alone or combined with semaglutide) has been administered via subcutaneous injection using a prefilled pen, similar to other peptide-based obesity therapies. It is not currently available for prescription outside of clinical trials, and no FDA-approved dosing regimen exists for the standalone compound.
- The Lancet · 2021 Cagrilintide plus semaglutide for obesity management
- The Lancet Diabetes & Endocrinology · 2023 Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial
- New England Journal of Medicine · 2025 Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes
Curated from published literature for research orientation. Not an exhaustive review, and not a substitute for reading primary sources.
- Post Hoc Analysis of REDEFINE 1 Shows CagriSema Drove 25% Average Weight Loss in Women —
- CagriSema Outperforms Tirzepatide for Weight Loss in Two New Phase 3 Trials —