What Is Cagrilintide?

1. The Short Answer

Cagrilintide is Novo Nordisk’s investigational long-acting amylin analogue. Novo’s September 2025 REDEFINE 1 monotherapy release states that once-weekly cagrilintide 2.4 mg produced an 11.8% body-weight reduction versus 2.3% with placebo after 68 weeks under the trial-product estimand (which estimated the effect if all participants stayed on treatment).

Cagrilintide is also one half of CagriSema, Novo’s investigational fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg. Novo submitted CagriSema to the U.S. FDA on December 18, 2025, noting that CagriSema is not yet approved in the U.S. or EU. Novo’s February 2026 update said an FDA decision is anticipated by late 2026, and its August 2026 half-year report still lists the CagriSema U.S. decision among its remaining 2026 milestones, expected in the fourth quarter. Standalone cagrilintide has no FDA-approved U.S. product label as of October 15, 2026.

For the hormone background and the first amylin analog, see What Is Pramlintide?. For the combination product, see What Is CagriSema?. For another weekly amylin analogue in development, see What Is Petrelintide?.

2. Cagrilintide, AM833, and NNC0174-0833

Cagrilintide has been studied under several development names. Guide to Pharmacology lists synonyms including AM-833, AM833, analogue 23, and NN0174-0833. ClinicalTrials.gov uses NNC0174-0833 in the older phase 2 trial record, NCT03856047.

Use the names this way:

A single molecule can carry several designations before a product reaches an approved label. However, issues arise when sellers use old development codes to imply availability, dosing, or regulatory status that does not exist.

3. How Does Cagrilintide Work?

Cagrilintide targets the amylin pathway. Novo Nordisk refers to it as a long-acting amylin analogue. Guide to Pharmacology describes it as a lipidated, long-acting analogue of amylin with activity at calcitonin-family receptors. The phase 2 Lancet paper notes that amylin is a pancreatic beta-cell hormone that acts as a satiety signal, slows gastric emptying, and suppresses meal-related glucagon response.

In short, cagrilintide is built to mimic and extend an amylin-like signal.

While it is frequently discussed alongside GLP-1 drugs for obesity management, cagrilintide is not a GLP-1. Semaglutide is the GLP-1 receptor agonist, and cagrilintide is the amylin analogue. CagriSema combines the two. This distinction is important; claiming that cagrilintide is the same as semaglutide is factually incorrect.

4. Is Cagrilintide FDA-Approved?

No standalone cagrilintide product is FDA-approved as of October 15, 2026. Novo’s public cagrilintide monotherapy release details trial data, and the RENEW phase 3 program it announced began in November 2025. That represents research progress, not a product label.

CagriSema has a separate regulatory timeline. Novo submitted a U.S. New Drug Application for CagriSema in December 2025 for weight management in adults with obesity or overweight and at least one weight-related comorbidity. Novo expects the FDA decision in the fourth quarter of 2026, and no approval had been announced as of October 15, 2026. A CagriSema submission is not the same as a standalone cagrilintide approval.

FDA’s page on unapproved GLP-1 drugs used for weight loss, current as of October 1, 2026, states that cagrilintide cannot be used in compounding under federal law, is not a component of any FDA-approved drug, and has not been found safe and effective for any condition.

The FDA has warned about unapproved products marketed as alternatives to approved GLP-1 drugs. Because online sellers often mistakenly file amylin analogues under the broad “GLP-1 peptide” bucket, it is vital to distinguish between a verified trial molecule, a pending NDA, and unauthorized gray-market formulations.

5. What Did the Phase 2 Trial Report?

The phase 2 cagrilintide dose-finding trial, registered as NCT03856047, enrolled 706 participants and tested once-weekly cagrilintide doses from 0.3 mg to 4.5 mg against placebo and liraglutide 3.0 mg. ScienceDirect’s Lancet record notes the trial ran at 57 sites in 10 countries and included adults without diabetes who had obesity or overweight with hypertension or dyslipidemia.

At week 26, mean body-weight reductions were 6.0% to 10.8% across the cagrilintide dose groups versus 3.0% with placebo under the trial-product estimand. The 4.5 mg cagrilintide group lost 10.8% versus 9.0% with liraglutide 3.0 mg.

Safety profiles were also reported. Gastrointestinal adverse events were more common with cagrilintide than placebo, ranging from 41% to 63% across cagrilintide dose groups versus 32% with placebo. Nausea was the most common side effect, reported in 20% to 47% of cagrilintide participants versus 18% with placebo.

The phase 2 trial focused heavily on dose finding, assessing GI tolerability, and establishing a path into larger phase 3 studies.

6. What Did REDEFINE 1 Report for Cagrilintide Alone?

REDEFINE 1 is primarily known as a CagriSema trial, but it included a cagrilintide 2.4 mg monotherapy arm. The NEJM report lists 3,417 randomized participants, 302 of them assigned to cagrilintide alone. ClinicalTrials.gov lists REDEFINE 1 as NCT05567796, a phase 3 study of CagriSema in people with obesity, with cagrilintide, semaglutide, and matched placebo interventions.

Novo’s September 16, 2025 release detailed a cagrilintide monotherapy sub-analysis from REDEFINE 1. The company reported an average body-weight reduction of 11.8% with cagrilintide 2.4 mg versus 2.3% with placebo after 68 weeks under the trial-product estimand. Under the treatment-policy estimand, which counts the effect regardless of adherence, Novo reported an 11.5% reduction with cagrilintide versus 3.0% with placebo.

Novo also stated that 31.6% of cagrilintide participants achieved at least 15% weight loss, compared with 4.7% for placebo, under the trial-product estimand. Under the treatment-policy estimand, the figures were 31.0% and 5.2%.

Novo reported that the most common side effects were gastrointestinal, including nausea, vomiting, diarrhea, and constipation, which were mainly temporary and mild to moderate. Nausea led to permanent discontinuation in 1.0% of cagrilintide participants versus 0.1% with placebo.

While these figures supported Novo’s decision to move cagrilintide into a dedicated phase 3 program, they do not mean cagrilintide is an approved obesity medication on its own.

7. What Is the RENEW Program?

Novo announced that the dedicated phase 3 RENEW program would study cagrilintide in people with obesity or overweight, with an expected start in the fourth quarter of 2025. Novo’s Q3 2025 report confirmed the program began in November 2025 with two 64-week, placebo-controlled trials of cagrilintide 2.4 mg: RENEW 1 in 300 people with overweight or obesity, and RENEW 2 in 330 people with overweight or obesity and type 2 diabetes.

RENEW 1, NCT07220642, and RENEW 2, NCT07220759, both started on November 5, 2025, and are listed as active, not recruiting, with estimated completion dates of June 29 and June 30, 2027. These are research records, not prescribing documents.

Novo has since added more cagrilintide trials:

• RENEW 4, NCT07745504, a 26-week phase 3 trial that began in August 2026 and compares two injection-device presentations of cagrilintide with placebo in about 285 adults with overweight or obesity.
• NCT07253285, a recruiting phase 3 trial of cagrilintide 2.4 mg alone and CagriSema in children and adolescents with overweight or obesity.
• Novo’s August 2026 half-year report lists initiation of a high-dose cagrilintide phase 3 trial among its remaining 2026 milestones.

No RENEW results have been reported as of October 15, 2026.

Key differences between REDEFINE and RENEW:

Both programs are sponsored by Novo Nordisk but address different clinical questions.

8. Cagrilintide vs CagriSema

Cagrilintide is a single molecule. CagriSema is a combination product. Novo describes CagriSema as a once-weekly subcutaneous injection containing cagrilintide 2.4 mg plus semaglutide 2.4 mg.

Key differences:

The abbreviation “cagri” is sometimes incorrectly used online to refer interchangeably to raw powder, trial interventions, or the CagriSema combination product. These are distinct entities.

For the older approved amylin analog context, see What Is Symlin?. For semaglutide, see What Is Semaglutide?.

9. Is Cagrilintide Safer Than GLP-1 Drugs?

Public data do not support a simple “safer than GLP-1” label. Novo has described cagrilintide as working differently than approved GLP-1-based treatments, and the September 2025 release pointed to a favorable tolerability profile within its trial context. This is not equivalent to head-to-head safety labeling across approved drugs.

Current public safety data highlights include:

While trial evidence is valuable, an approved label provides the finalized reviewed wording for indications, contraindications, warnings, adverse reactions, drug interactions, and use in specific populations. Cagrilintide does not have a standalone U.S. label yet.

10. How to Record Cagrilintide Cleanly

Key specifications to distinguish the molecule from the product context:

In summary, cagrilintide is the amylin analogue and CagriSema is the combination product. Neither term should be used as a standalone dosing instruction.

11. Cagrilintide FAQ

• What is cagrilintide in simple terms?

  Cagrilintide is Novo Nordisk's investigational long-acting amylin analogue, also known as AM833 or NNC0174-0833. It is being studied as a once-weekly subcutaneous treatment for adults with overweight or obesity.

• Is cagrilintide a GLP-1?

  No. Cagrilintide is not a GLP-1 receptor agonist. Novo calls it a long-acting amylin analogue. It is combined with the GLP-1 receptor agonist semaglutide in CagriSema.

• Is cagrilintide FDA-approved?

  No standalone cagrilintide product is FDA-approved as of October 15, 2026. Novo has submitted CagriSema, which contains cagrilintide plus semaglutide, but that is a combination product, it is not approved in the U.S. or EU, and Novo expects a U.S. decision in the fourth quarter of 2026.

• Can cagrilintide be compounded?

  No. FDA states that cagrilintide cannot be used in compounding under federal law, is not a component of any FDA-approved drug, and has not been found safe and effective for any condition.

• What did REDEFINE 1 report for cagrilintide alone?

  Novo reported that once-weekly cagrilintide 2.4 mg produced 11.8% body-weight reduction versus 2.3% with placebo after 68 weeks under the trial-product estimand in a REDEFINE 1 sub-analysis.

• What is the difference between cagrilintide and CagriSema?

  Cagrilintide is one molecule, a long-acting amylin analogue. CagriSema is Novo Nordisk's investigational fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg.

12. Sources