# CagriSema

Two peptides in one weekly injection: cagrilintide, a long-acting copy of the fullness hormone amylin, and semaglutide. Filed with FDA and awaiting a decision.

Also called: Cagrilintide + semaglutide
Source page: https://peplogue.com/peptides/cagrisema/
Reviewed: 2026-10-12. Not medical advice.

## How it works

- Where it acts: Amylin receptors (cagrilintide) and GLP-1 receptors (semaglutide) in the brain and gut.
- What it changes: Two fullness signals at once, plus a slower-emptying stomach.
- What people notice: In trials, more weight loss than semaglutide alone. Stomach side effects are common.

## What the evidence shows

- **Weight loss in obesity**: Supported. REDEFINE 1 (3,417 people, 68 weeks): 22.7% average loss among people who stayed on it and 20.4% counting everyone, against 3.0% on placebo. Head to head, it reached 23% at 84 weeks but failed to show it was as good as tirzepatide 15 mg.
- **Type 2 diabetes**: Supported. REDEFINE 2: 15.7% weight loss against 3.1% on placebo. A low dose beat low-dose tirzepatide on weight in REIMAGINE 5 (12.4% against 9.1%).

## Side effects and risks

- common: Stomach and bowel side effects in about 80% of people, against 40% on placebo.
- common: About 6% stopped because of side effects.
- unknown: Carries the known semaglutide risks; the combination is still under regulatory review.

Who should avoid it: Anyone outside a clinical trial.

## How it has been given in trials

Weekly injection under the skin: 2.4 mg of each component after a stepwise increase. There is no approved dose yet.

## Legal status

- United States: undefined. Filed in December 2025. No decision announced by 12 October 2026.
- European Union: undefined. No EU filing confirmed.
- Spain: undefined. Investigational. Neither cagrilintide nor CagriSema is in CIMA. The only lawful route is a clinical trial; Spanish trial sites not verified.
- Germany: undefined. Not authorised in Germany; no EU filing confirmed. Only in clinical trials. Sale outside trials is unlawful under the AMG (§ 21, § 96).
- France: undefined. No French or EU authorisation found; no EU filing confirmed. The only lawful route is a clinical trial.
- Italy: undefined. Not authorised in the EU or Italy; no EU filing confirmed. Only reachable through a clinical trial. Italian trial sites not checked.
- Netherlands: undefined. No Dutch marketing authorisation. Only in clinical trials; an EU filing is not confirmed. Selling it without authorisation is illegal.
- United Kingdom: undefined
- Canada: undefined
- Australia: undefined

## Questions people ask

**When will CagriSema be approved?**

It was filed with FDA in December 2025, and a decision is expected by the end of 2026. No decision had been announced by 12 October 2026, and no EU filing is confirmed.

**How much weight loss does CagriSema give?**

In REDEFINE 1 (3,417 people, 68 weeks), average loss was 22.7% among people who stayed on it and 20.4% counting everyone, against 3.0% on placebo.

**Is CagriSema better than tirzepatide (Zepbound)?**

Head to head, CagriSema reached 23% loss at 84 weeks but failed to show it was as good as the top dose of tirzepatide. In type 2 diabetes, a low dose beat low-dose tirzepatide on weight in REIMAGINE 5, 12.4% against 9.1%.

**What are the side effects of CagriSema?**

Stomach and bowel side effects affected about 80% of people in trials, against 40% on placebo, and about 6% stopped because of side effects. It also carries the known semaglutide risks.

**What is in CagriSema?**

Two peptides in one weekly injection: cagrilintide, a long-acting copy of the fullness hormone amylin, and semaglutide.

## Sources

- Novo Nordisk: CagriSema filed with FDA (18 Dec 2025): https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916470
- Novo Nordisk: REIMAGINE 5 and REDEFINE 9 results (21 Sep 2026): https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916774
- Drugs.com: CagriSema development timeline: https://www.drugs.com/history/cagrisema.html