Peptide Graded

All peptides / Gut and weight

Cagrilintide

Long-acting amylin analog

Also AM833, NN9838, NNC0174-0833, Cagri

Evidence
BSome human evidence
FDA status
In clinical trialsas of 2026-10-27
Route
Injection
Studies cited
5 human0 animal or cell

It is a weekly shot being tested for weight loss, mainly together with semaglutide. Alone it caused about 6% to 11% weight loss in a 26-week trial, and it is not approved.

Sold for

Cagrilintide is talked about as the amylin half of CagriSema, Novo Nordisk's attempt to beat tirzepatide on weight loss, and as a weekly injection that could work on its own.

Studies say

Randomized trials show cagrilintide alone produces about 6% to 11% weight loss at 26 weeks depending on dose, and with semaglutide about 20% at 68 weeks, with mainly gastrointestinal side effects (grade B pending standalone phase 3).

Why grade B. For weight loss, cagrilintide alone has a 706-participant randomized phase 2 dose-finding trial and a 96-participant phase 1b combination trial; the 3,417-participant REDEFINE 1 phase 3 trial tested it mainly in combination with semaglutide, with a 302-person cagrilintide-alone arm. Randomized trials exist but the standalone drug has no completed phase 3 and no approval, which is grade B. 7811

FDA. Cagrilintide is an investigational long-acting amylin analogue from Novo Nordisk and is not approved by the FDA or any other regulator on its own. Novo Nordisk submitted its fixed-dose combination with semaglutide (CagriSema) to the FDA in December 2025, and no FDA decision had been announced by late October 2026. A standalone phase 3 trial of cagrilintide started in November 2025.

Written from 15 cited sources. Last refreshed 2026-10-27. Not physician reviewed.

What this means for you

What people take it for
Losing weight
Can a US doctor prescribe it?
Not yet; it is still in trials.
Properly tested in people?
Partly: some human trials, with gaps. The main trial of the drug alone had 706 people.

Evidence checklist

  • Randomised controlled trial 706-person phase 2; REDEFINE 1 phase 3yes
  • Human study over 100 people REDEFINE 1, 3,417 adults (mostly combination)yes
  • More than one research group Trials appear to be from the maker; not statedno information
  • Clinical outcomes, not surrogate markers Weight change, not heart or other outcomesno
  • Human safety data beyond case reports Trial data to 68 weeks; GI effects commonyes

Drawn from the cited studies below. A dash means the sources give no information.

What it is

Cagrilintide is a lab-made version of amylin. Amylin is a hormone of 37 amino acids that the pancreas releases with insulin after meals. Natural amylin breaks down within minutes and tends to clump into fibrils. Cagrilintide has amino acid changes and a fatty acid side chain. These stop the clumping and let it bind albumin. That extends its action to a week. 17

The only approved amylin drug is pramlintide (Symlin). It is a short-acting shot taken with meals. Doctors use it as an add-on to insulin in diabetes. Cagrilintide was built to be injected once a week. It was built for obesity, not for glucose control. Novo Nordisk is developing it alone. It is also developing CagriSema, a mix of cagrilintide and semaglutide. 36

How it works

Amylin acts on receptors in the brain. Each is made of the calcitonin receptor paired with one of three receptor activity-modifying proteins. They sit in the area postrema of the brainstem and in the hypothalamus. There, amylin signals fullness after a meal. It also slows stomach emptying and suppresses glucagon. Cagrilintide activates both amylin and calcitonin receptors. So it is called a dual amylin and calcitonin receptor agonist. 12

GLP-1 drugs like semaglutide cut appetite through different brain circuits. The idea behind CagriSema is that the two signals add together. In trials of the combination, weight loss beat what either drug produced alone. 311

What human research shows

The phase 2 dose-finding trial was published in The Lancet in 2021. It randomized 706 adults with overweight or obesity and no diabetes. They got one of five weekly cagrilintide doses, daily liraglutide or placebo for 26 weeks. Weight fell by 6.0% to 10.8% across the cagrilintide doses. It fell 3.0% with placebo. The highest dose beat liraglutide. Dropout was similar across groups. 7

REDEFINE 1 was a 68-week phase 3 trial published in the New England Journal of Medicine in 2025. It randomized 3,417 adults with obesity or overweight plus a complication. They got CagriSema, semaglutide alone, cagrilintide alone or placebo. Weight fell 20.4% with CagriSema versus 3.0% with placebo. More people on the combination lost 20%, 25% and 30% of their weight than on placebo. For comparison, semaglutide alone produced 14.9% weight loss at 68 weeks in STEP 1 (1,961 participants). Tirzepatide at its highest dose produced 20.9% at 72 weeks in SURMOUNT-1 (2,539 participants). 8910

An earlier phase 1b trial in 96 participants showed that cagrilintide could be given with semaglutide. Weight loss reached about 17% over 20 weeks at the highest combination dose. A thorough QT study in 105 healthy volunteers found no clinically relevant effect on the heart's electrical recovery. In late 2025, Novo Nordisk announced that a standalone phase 3 trial of cagrilintide had started. 41113

StudyModelFinding
Lau 2021, Lancet (phase 2)Humans, n=706 with overweight or obesity, randomized double-blind placebo- and liraglutide-controlled, 26 weeksWeight loss of 6.0% to 10.8% across doses versus 3.0% with placebo; highest dose exceeded liraglutide. 7
REDEFINE 1, NEJM 2025Humans, n=3,417, randomized double-blind, CagriSema vs semaglutide vs cagrilintide vs placebo, 68 weeksWeight loss 20.4% with CagriSema versus 3.0% with placebo; gastrointestinal events in 79.6% versus 39.9%. 8
Enebo 2021, Lancet (phase 1b)Humans, n=96, randomized placebo-controlled multiple ascending dose with semaglutide, 20 weeksCombination was tolerable with weight loss up to about 17% at the highest cagrilintide dose. 11
Thorough QT study, 2024Humans, n=105 healthy volunteers, randomized double-blindNo clinically relevant QTc prolongation at the highest dose tested. 13

Safety

Stomach and gut effects dominate. In REDEFINE 1, 79.6% of people on CagriSema reported nausea, vomiting, diarrhoea, constipation or abdominal pain. On placebo it was 39.9%. Most cases were mild to moderate and passed. In the phase 2 trial of cagrilintide alone, 4% of participants stopped treatment because of adverse events. 78

A dedicated heart study found no QT prolongation. No one has studied cagrilintide for more than 68 weeks. The amylin class has little long-term data beyond pramlintide. So questions remain about rare events, weight regain after stopping and effects on lean mass. Compounded 'cagrilintide' sold online is not the trial product. The FDA has stated it cannot lawfully be compounded. 513

Questions for your clinician

  • Is cagrilintide alone tested, or only in combination with semaglutide?
  • What is known about use beyond 68 weeks?
  • How do its side effects compare with drugs already approved for weight loss?

Questions people ask

Has the FDA approved cagrilintide yet?

No. Neither cagrilintide alone nor CagriSema is approved. Novo Nordisk sent CagriSema to the FDA in early 2026. A standalone phase 3 trial of cagrilintide is under way. 415

How is cagrilintide unlike pramlintide?

Both are amylin analogues. Pramlintide (Symlin) is approved as an add-on to mealtime insulin in diabetes. It lasts only hours, so patients inject it before each meal. Cagrilintide is built to last a week and is being developed for obesity. 67

Is cagrilintide on its own the same as CagriSema?

CagriSema is cagrilintide plus semaglutide in one weekly injection. In the 3,417-person REDEFINE 1 trial, the combination produced 20.4% weight loss at 68 weeks. That was far more than either part alone. 38

Which looks stronger, cagrilintide or eloralintide?

Eloralintide is Eli Lilly's selective amylin receptor agonist. In a 263-participant phase 2 trial it produced up to 20% weight loss at 48 weeks. Cagrilintide alone reached 10.8% at 26 weeks in its phase 2 trial. No one has compared the two head to head. The trials differ in length and dose ranges. 714

Can I get cagrilintide from a compounding pharmacy?

Not lawfully. The FDA says drugs still in testing, like cagrilintide, cannot be compounded under federal law. That covers GLP-1 and amylin products. Products sold online under this name have no regulatory oversight. 5

Citations

  1. Lau 2021, Lancet: once-weekly cagrilintide for weight management, phase 2 dose-finding trial (DOI) doi.org
  2. StatPearls: Glucagon-like peptide-1 receptor agonists and the incretin system ncbi.nlm.nih.gov
  3. Garvey 2025, NEJM: coadministered cagrilintide and semaglutide (REDEFINE 1) (DOI) doi.org
  4. ClinicalTrials.gov: standalone phase 3 trial of cagrilintide clinicaltrials.gov
  5. FDA: concerns with unapproved GLP-1 drugs used for weight loss fda.gov
  6. DailyMed: Symlin (pramlintide) label dailymed.nlm.nih.gov
  7. Lau 2021, Lancet: once-weekly cagrilintide for weight management, phase 2 trial pubmed.ncbi.nlm.nih.gov
  8. Garvey 2025, NEJM: coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1) pubmed.ncbi.nlm.nih.gov
  9. Wilding 2021, NEJM: once-weekly semaglutide in adults with overweight or obesity (STEP 1) pubmed.ncbi.nlm.nih.gov
  10. Jastreboff 2022, NEJM: tirzepatide once weekly for the treatment of obesity (SURMOUNT-1) pubmed.ncbi.nlm.nih.gov
  11. Enebo 2021, Lancet: cagrilintide with semaglutide, phase 1b trial pubmed.ncbi.nlm.nih.gov
  12. Lancet 2025: amycretin, a unimolecular GLP-1 and amylin receptor agonist, phase 1b/2a pubmed.ncbi.nlm.nih.gov
  13. Diabetes Obes Metab 2024: cagrilintide thorough QT study pubmed.ncbi.nlm.nih.gov
  14. Lancet 2025: eloralintide, a selective amylin receptor agonist, phase 2 trial pubmed.ncbi.nlm.nih.gov
  15. Novo Nordisk Q4 2025 report (SEC filing): CagriSema submitted to the FDA sec.gov

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