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Medicine information

CagriSema

An investigational once-weekly injection combining cagrilintide, an amylin analogue, with semaglutide, a GLP-1 receptor agonist. It is not authorised in the EU.

General information, not medical advice. Docalo does not sell medicines, and prescription-only medicines are prescribed only after an individual medical assessment.

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Medicine information

What CagriSema is and how it works

CagriSema pairs two hormone copies in one pen: semaglutide, which acts like the gut hormone GLP-1, and cagrilintide, which acts like amylin, a hormone the pancreas releases after eating. Both act on appetite.

It has completed Phase 3 trials (REDEFINE 1 and 2). The manufacturer applied for US approval in December 2025; it holds no EU authorisation.

Authorisation status and label

  • No one outside a clinical trial in the EU: it has no authorised indication.
  • Phase 3 trials studied adults with obesity or overweight, with and without type 2 diabetes.
  • Each trial sets its own eligibility criteria, and the trial team checks them.

Only a doctor who knows your history can decide whether a medicine suits you.

How to use CagriSema

Only within a clinical trial. In trials it was given as one injection under the skin once a week, with doses built up over several weeks under the study protocol.

No authorised dosing. There is no authorised dose outside a trial.

Common side effects

Get urgent medical help if (whatever the frequency): Severe, persistent stomach pain, often spreading to the back, Pain under the right ribs with fever or yellowing skin, Swelling of the face, lips, tongue or throat, or trouble breathing

Most reported in trials (in more than 1 in 10 trial participants): nausea, constipation, vomiting

Safety

Do not use CagriSema if

  • You are outside a registered clinical trial, because no authorised product exists
  • You are pregnant, planning a pregnancy or breastfeeding
  • The product comes from an online seller, because its content, dose and sterility are unchecked

Pancreatitis and gallbladder problems are known risks of medicines in this class.

FAQs

Your questions answered

CagriSema3 questions
Is CagriSema authorised in the EU?
No. It is an investigational medicine. The manufacturer applied for US approval in December 2025, and there is no EU authorisation.
A long-acting copy of amylin, a hormone the pancreas releases together with insulin after meals. Amylin slows stomach emptying and signals fullness.
More questions
No legitimate product exists outside clinical trials. Anything sold online under that name is unregulated, with no checked content, dose or sterility.

References

This page summarises the official product information and the published sources below.

  1. Cagrilintide–semaglutide in adults with overweight or obesity (REDEFINE 1) New England Journal of Medicine, 2025
  2. Cagrilintide–semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE 2) New England Journal of Medicine, 2025
  3. REDEFINE 1 (NCT05567796) ClinicalTrials.gov, 2025
  4. REDEFINE 2 (NCT05394519) ClinicalTrials.gov, 2025
  5. Novo Nordisk files for FDA approval of CagriSema Novo Nordisk A/S, 2025

Other medicines used in weight management

Talk to a doctor about weight care

The Docalo membership gives you a doctor's assessment, a personalised plan and monthly follow-up. Your doctor decides what care suits you, with or without medicine.

Talk to a doctor about weight careGeneral information, not medical advice. Docalo does not sell medicines, and prescription-only medicines are prescribed only after an individual medical assessment.
All content on this page has been medically reviewed by: Dr. Alejandro Infante, General medicine, on 27 July 2026. Registration: 080869277

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