At a glance

What is cagrilintide?

Cagrilintide is an experimental drug that mimics amylin, a hormone the pancreas releases alongside insulin that signals fullness. It was engineered by Novo Nordisk to last long enough for once-weekly injection and has been studied for weight management. It is investigational and not approved for any use, and much of its development now centers on pairing it with semaglutide in the combination CagriSema. Cagrilintide’s development codes are AM833 and NNC0174-0833.

How does it work?

Cagrilintide acts at amylin and calcitonin receptors¹, mimicking the natural hormone amylin. Activating these receptors is associated with three effects, which together reduce food intake:

• Greater satiety
• Slower stomach emptying
• Suppression of glucagon after meals

Because this is a different pathway from the GLP-1 incretin system², cagrilintide is also studied in combination³ with GLP-1 drugs on the theory that the two mechanisms complement each other. This describes the proposed mechanism rather than a proven outcome.

Is it FDA-approved?

No. Cagrilintide is investigational and not approved by the FDA or any other regulator. Most of its late-stage development is as part of CagriSema, though Novo Nordisk has also started a standalone Phase 3 trial⁴ of cagrilintide alone.

What does the research show?

The main standalone evidence is one Phase 2 trial. According to PubMed, a 26-week dose-finding trial¹ in people with overweight or obesity without diabetes reported weight reductions across a range of doses compared with placebo, with gastrointestinal effects as the most common side effect. This is a single, limited Phase 2 study; cagrilintide alone has not completed a Phase 3 trial for obesity, so its standalone efficacy and long-term profile are not established.

Frequently asked questions

Is cagrilintide FDA-approved?

No. As of September 2026, cagrilintide is not FDA-approved for any indication. It is an investigational compound under development by Novo Nordisk, is not available by prescription, and cannot be used in compounding under federal law⁵. The furthest-advanced regulatory pathway is CagriSema, the combination of cagrilintide and semaglutide.

Can a doctor prescribe cagrilintide?

No. Cagrilintide is not FDA-approved, and it cannot be used in compounding under federal law⁵, so there is no approved or compounded form for a provider to prescribe. Access is limited to enrollment in a Novo Nordisk clinical trial.

What is the difference between cagrilintide and pramlintide?

Both are amylin analogs that activate amylin receptors to reduce food intake, slow gastric emptying, and suppress postprandial glucagon. Pramlintide (Symlin) is FDA-approved as an adjunct to mealtime insulin⁶ in type 1 and type 2 diabetes. Cagrilintide is engineered for once-weekly dosing and achieved up to 10.8% weight loss⁷ at its highest dose in a 26-week Phase 2 monotherapy trial. This comparison is for scientific context only; these compounds have different regulatory statuses and evidence bases.

What is the difference between cagrilintide and CagriSema?

Cagrilintide is the amylin component of the CagriSema regimen. CagriSema refers to the co-administration of cagrilintide and semaglutide. The Phase 3 REDEFINE 1 trial of CagriSema showed 20.4% mean weight loss over 68 weeks⁸ in adults with overweight or obesity without diabetes. This page covers cagrilintide as the amylin component in isolation; the CagriSema article covers the combination's Phase 3 data and regulatory status.

Is cagrilintide being developed as a standalone drug?

Partly. Most of its late-stage development is as part of CagriSema, but Novo Nordisk has also started a standalone Phase 3 trial⁴, RENEW 1, comparing cagrilintide alone with placebo in people with overweight or obesity. In separate trials, the Phase 2 monotherapy data showed up to 10.8% weight loss at 26 weeks⁷, below the 14.9% shown by semaglutide 2.4 mg⁹ alone in the STEP 1 trial and the 20.9% shown by tirzepatide 15 mg¹⁰ in SURMOUNT-1. The combination of cagrilintide with semaglutide 2.4 mg produced 17.1% weight loss at 20 weeks¹¹ in a Phase 1b trial and 20.4% in the REDEFINE 1 Phase 3 trial. Novo Nordisk is also developing amycretin, a single-molecule GLP-1 and amylin receptor agonist¹².

What are the side effects of cagrilintide?

In the 26-week Phase 2 trial, which assigned 706 participants to cagrilintide, the most common adverse events were gastrointestinal: 41% to 63% of cagrilintide-treated participants⁷ had a gastrointestinal event depending on dose, mainly nausea, versus 32% in the placebo group. A 2024 thorough QT cardiac safety study enrolled 105 healthy participants and found no clinically relevant QTcF prolongation¹³ at any measured time point after the final 4.5 mg dose. Long-term safety data beyond 26 weeks for cagrilintide monotherapy is limited.

How does cagrilintide compare to eloralintide?

Eloralintide is Lilly's once-weekly selective amylin receptor agonist¹⁴. Its 48-week Phase 2 trial showed dose-dependent weight reductions ranging from about 9% to 20% depending on dose. These results come from a separate trial of a different length, so they cannot be ranked against cagrilintide's 26-week monotherapy result. This comparison is for scientific context only; these compounds have different regulatory statuses and evidence bases.

Will cagrilintide become available through compounding pharmacies?

Not under current federal law. FDA states that cagrilintide cannot be used in compounding⁵ and is not a component of any FDA-approved drug. It is an investigational Novo Nordisk compound, and the nearest approval pathway is CagriSema, which Novo Nordisk has submitted to the FDA for review¹⁵.

More for digestive & weight