Cagrilintide: how it works, studies and approval status

Cagrilintide mimics the fullness hormone amylin and is being studied as a medicine for weight management. In a 26-week phase 2 trial, people with overweight or obesity who did not have diabetes lost weight while taking it. How effective cagrilintide is on its own, and how safe long-term treatment would be, are not yet settled. The experimental medicine is being studied mainly alongside semaglutide, a combination called CagriSema.

What is cagrilintide?

Cagrilintide is an experimental medicine that mimics amylin. The pancreas releases this hormone alongside insulin, signaling fullness. Novo Nordisk designed cagrilintide to act long enough for a once-weekly injection. Researchers are investigating whether it is suitable for weight management.

At the development stage described here, cagrilintide is not approved for any use. Much of the research now focuses on CagriSema, the combination with semaglutide. In trials, cagrilintide also appears under the development codes AM833 and NNC0174-0833.

How does cagrilintide work?

Cagrilintide activates amylin and calcitonin receptors, mimicking the natural hormone amylin. This receptor activation is associated with three effects that together reduce food intake: 1

• A stronger feeling of fullness.
• Slower stomach emptying.
• Less glucagon release after meals.

This pathway differs from the GLP-1 incretin system, a hormonal system involved in regulating metabolism. Researchers are therefore also studying cagrilintide alongside GLP-1 medicines: the two mechanisms might complement each other. Whether the combination offers a treatment advantage can only be judged from trial findings. The proposed mechanism alone does not establish that advantage. 2, 3

Is cagrilintide FDA-approved?

No. At the stage described here, neither the US Food and Drug Administration nor any other regulatory authority has approved cagrilintide. Most late-stage trials study CagriSema. Novo Nordisk has, however, also started a standalone phase 3 trial of cagrilintide on its own. 4

What does the research show?

The main basis for assessing cagrilintide alone is a phase 2 dose-finding study. It lasted 26 weeks and included people with overweight or obesity who did not have diabetes. Researchers tested different doses and reported weight loss compared with placebo. Gastrointestinal symptoms were the most common side effects. 1

The conclusions that can be drawn from this single phase 2 study are limited. At the development stage described here, no phase 3 trial studying cagrilintide alone for obesity has been completed. How effective the individual medicine is, and how its benefits and risks balance over the long term, therefore remain open questions.

Frequently asked questions

Is cagrilintide FDA-approved?

No. As of September 2026, the FDA has not approved cagrilintide for any indication. Novo Nordisk is developing the medicine; it is not available on prescription. Under US federal law, cagrilintide also cannot be used in compounding, the preparation of individualized medicines by pharmacies. 5 CagriSema, the combination of cagrilintide and semaglutide, is furthest along the path toward possible approval.

Can a doctor prescribe cagrilintide?

Under the US legal position described here, no. Cagrilintide is neither FDA-approved nor permitted for compounding under US federal law. There is therefore no approved or compounded form that a doctor could prescribe. 5 Access is available only through participation in a Novo Nordisk clinical trial.

How do cagrilintide and pramlintide differ?

Both medicines are amylin analogues: they mimic the hormone amylin by activating its receptors. This reduces food intake, slows stomach emptying and suppresses glucagon release after meals.

Pramlintide (Symlin) is FDA-approved as an addition to mealtime insulin in type 1 and type 2 diabetes. 6 Cagrilintide was designed for once-weekly use. In a 26-week phase 2 study of cagrilintide alone, weight loss reached up to 10.8% at the highest dose tested. 7

The medicines therefore differ in both approval status and the available studies. Comparing them helps put the science in context; it does not provide a recommendation for choosing a medicine.

How do cagrilintide and CagriSema differ?

Cagrilintide is one of the two active ingredients in CagriSema. The name CagriSema refers to the combined use of cagrilintide and semaglutide. In the phase 3 REDEFINE 1 trial, adults with overweight or obesity and without diabetes lost an average of 20.4% of their weight over 68 weeks with this treatment. That result applies to the combination. 8

The separate CagriSema article explains the combination’s phase 3 data and approval status in more detail.

Is cagrilintide also being developed as a standalone medicine?

Yes. Although most late-stage clinical trials study CagriSema, Novo Nordisk has also started the standalone phase 3 RENEW 1 trial. It compares cagrilintide alone with placebo in people with overweight or obesity. 4

In the phase 2 study of cagrilintide alone, weight loss reached up to 10.8% after 26 weeks. 7 For context, STEP 1 reported 14.9% weight loss with semaglutide 2.4 mg alone, while SURMOUNT-1 reported 20.9% with tirzepatide 15 mg. The cagrilintide figure was therefore lower. These numbers come from separate trials, however, and do not allow a direct comparison of the medicines. 9, 10

The combination with semaglutide has also been studied at several stages of development. In a phase 1b trial, cagrilintide together with semaglutide 2.4 mg produced 17.1% weight loss after 20 weeks. 11 In the phase 3 REDEFINE 1 trial, weight loss with the combination was 20.4%. 8

Novo Nordisk is also developing amycretin. This single molecule activates both GLP-1 and amylin receptors. 12

What side effects does cagrilintide have?

Gastrointestinal symptoms were the most common adverse events in the 26-week phase 2 study. Depending on the dose, they affected 41% to 63% of participants receiving cagrilintide, with nausea the main complaint. In the placebo group, 32% reported such symptoms. 7

A cardiac safety study conducted in 2024 examined whether cagrilintide lengthened a particular interval in the heart’s electrical activity in 105 healthy people. This is called a thorough QT study; the corrected measure is known as the QTcF interval. After the last 4.5 mg dose, no clinically relevant prolongation of this interval was found at any measurement point. 13

Data on the safety of cagrilintide alone beyond 26 weeks are limited.

How does cagrilintide compare with eloralintide?

A direct comparison cannot be drawn from the studies cited. Eloralintide is a once-weekly medicine being developed by Lilly. As a selective amylin receptor agonist, it specifically activates amylin receptors. In a 48-week phase 2 trial, participants lost approximately 9% to 20% of their weight, depending on the dose. 14

This trial lasted longer than the 26-week study of cagrilintide alone. Results from the separate trials therefore do not establish which medicine performs better. Approval status and the available studies also differ. The comparison is intended to put the science in context.

Will cagrilintide become available through compounding pharmacies?

Under the US federal law described here, this route of supply is not permitted. That does not establish whether the position might change in future. The FDA states that cagrilintide cannot be used in compounding and is not an ingredient in an FDA-approved medicine. 5

Cagrilintide remains an experimental Novo Nordisk medicine. At the stage described here, CagriSema is closest to possible approval. Novo Nordisk has submitted the combination to the FDA for review. 15

Sources

• Sources: the Phase 2 dose-finding trial of cagrilintide (Lau et al., The Lancet, 2021, DOI: 10.1016/S0140-6736(21)01751-7 1), indexed on PubMed. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product. Original reference