All compounds
  • subcutaneous

CagriSema

CagriSema (Cagrilintide + Semaglutide)

Given as a subcutaneous injection

CagriSema at a glance

Not on either FDA list

How studies gave it

Injected into the fat under the skin

Evidence on this page

5 peer-reviewed papers, published 2021 to 2025

FDA compounding lists

It appears on neither of the two FDA compounding tables.

What it is

A fixed-dose combination of two peptides co-administered in a single weekly subcutaneous injection, developed by Novo Nordisk. Cagrilintide is a 37-amino-acid long-acting acylated amylin analogue; semaglutide is a 31-amino-acid GLP-1 receptor agonist. The two components target complementary satiety pathways — amylin receptors in the area postrema/hindbrain and GLP-1 receptors in the hypothalamus/brainstem.

Phase 3 data (REDEFINE 1) reported −22.7% on-treatment weight loss at 68 weeks. An NDA was filed with the FDA in December 2025.

Published research

Phase 1b (Enebo et al., Lancet 2021) showed cagrilintide 2.4 mg added to semaglutide 2.4 mg produced −17.1% total weight loss over 20 weeks. REDEFINE 1 (NEJM 2025; n=3,417) demonstrated −22.7% on-treatment weight loss at 68 weeks, with 23.1% achieving ≥30% loss. REDEFINE 2 (NEJM 2025; n=1,206) showed −15.7% weight loss in T2D with 73.5% reaching HbA1c ≤6.5%.

REDEFINE 4 compared CagriSema head-to-head vs tirzepatide 15 mg; CagriSema achieved ~23% loss but did not demonstrate statistical superiority. Preclinical data suggest approximately one-third of CagriSema's weight loss effect is attributed to preserved energy expenditure. Clinical titration co-escalates both components every 4 weeks from 0.25/0.25 mg to 2.4/2.4 mg.

What the terms on this page mean9 terms
peptide
A short chain of amino acids, the building blocks of proteins.
subcutaneous
Into the fat layer just under the skin.
analog
A molecule built to copy a natural one with a deliberate change, usually to make it last longer or bind more tightly.
GLP-1
Glucagon-like peptide 1, a gut hormone that raises insulin after eating and slows the stomach.
receptor
A docking point on a cell. A molecule that fits it can switch a process on or off inside that cell.
agonist
A molecule that binds a receptor and switches it on.
Phase 3
A large trial, the kind regulators read before approving a drug.
HbA1c
A blood test that averages blood sugar over roughly the previous three months.
preclinical
Laboratory and animal work done before any testing in people.

Compounding status

Not on either FDA list
FDA listing
CagriSema appears on neither FDA's category 2 table nor its table of withdrawn nominations.
What that means
Absence from both lists is not permission to compound. Section 503A allows a bulk drug substance only where a USP or NF monograph exists, or the substance is a component of an FDA-approved drug product, or it appears on the 503A bulks list.

Source: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, FDA. Content current as of 2026-04-22; read 2026-09-05. This describes what a compounding pharmacy may supply. It is not advice about your own use.

Reading up on CagriSema is the easy part

Keeping the schedule straight is the hard part. PepKit is the app for that.

  • Does the reconstitution math for you
  • Logs each dose and reminds you when the next is due
  • Counts down every vial's expiration

Also given subcutaneous

Where this came from5 references

Each one was resolved at PubMed and confirmed to be the work this page cites. Author, title, journal and year come from the PubMed record, not from the page text.

  1. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity

    Garvey WT, et al.. The New England journal of medicine (2025). PMID 40544433.

  2. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes

    Davies MJ, et al.. The New England journal of medicine (2025). PMID 40544432.

  3. 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

    Frias JP, et al.. Lancet (London, England) (2023). PMID 37364590.

  4. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight management: a randomised, controlled, phase 1b trial

    Enebo LB, et al.. Lancet (London, England) (2021). PMID 33894838.

  5. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial

    Lau DCW, et al.. Lancet (London, England) (2021). PMID 34798060.

About this page

Reviewed 2026-08-11. This page reports what published studies and FDA documents say. It carries no dose, cycle length or stack, and it does not tell you whether a substance is appropriate for you. Side-effect reports circulating on forums are self-reported rather than measured, so they are not republished here.

See the editorial policy for how corrections are handled.

Track your dosesMixing math, reminders, vial countdown