Cagrilintide
Reviewed
Short answer
An investigational peptide made to act like the body's amylin signal. Human weight-loss studies exist, but no FDA-approved product exists. Investigational in the United States; no FDA-approved cagrilintide product.
The Peptide Field explains research. Its pages are not independently medically reviewed, and they do not diagnose, prescribe, or recommend treatment.
Read the study findingsAlso known as NNC0174-0833 · AM833 · NN9833
Part of Metabolic peptide medicines
Legal status Is Cagrilintide legal? See the status table
Study and product details
What it is
Cagrilintide is an investigational amylin analogue. This means it is a modified peptide made to act like amylin, a body signal involved in appetite and blood-sugar control. Its chain has 37 amino acids and a fat-like side group that helps it last longer. Researchers have studied cagrilintide alone and with semaglutide. The combination is commonly called CagriSema.
Type of peptide: Modified peptide based on amylin. This describes what the substance is or how it works. It does not show that it is safe, effective, or approved.
What has been studied?
- Moderate: Useful evidence exists, but important limits remain.
- Limited: Research is too small or incomplete, or does not directly answer this question.
Randomized studies measured body-weight changes in people who received cagrilintide alone or with semaglutide. Each result has its own study limits.
A small study measured cagrilintide exposure and effects in people. It studied cagrilintide only with semaglutide, so it does not describe cagrilintide alone or every population.
The reviewed studies do not define the full long-term safety profile or rare risks.
High for the controlled material used in the studies; low for products sold outside those studies.
Products with the same ingredient can differ.
The ingredient name does not tell you everything about a product. Check its other ingredients, its form, how it enters the body, and the use and people covered by the research or approval.
None identified in the United States.
- Investigational weight-management programs
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What studies found
A 26-week phase 2 study tested cagrilintide alone in adults without diabetes. It required body mass index (BMI), a height-and-weight measure, of 30 or higher. BMI 27 or higher also qualified with high blood pressure or unhealthy blood-fat levels. A later 68-week study used BMI 30 or higher, or 27 or higher with a weight-related health problem. Every group received food and activity guidance. It had separate cagrilintide, semaglutide, CagriSema, and placebo groups.
FDA says cagrilintide is not a component of an approved drug and has not been found safe and effective for any condition. The reviewed records do not establish a complete long-term safety profile or show that online material matches study material. A trial record shows research information. It does not prove approval or availability.
Which products do these findings apply to?
Cagrilintide has been studied alone and with semaglutide. CagriSema is the investigational combination of the two molecules. Results for that combination do not automatically apply to cagrilintide alone, and the name does not prove that an online product matches study material.
Side effects reported in Cagrilintide trials
Cagrilintide is still being studied and is not FDA-approved. Its phase 2 trial posted side-effect results on ClinicalTrials.gov.
The most common side effects were stomach and bowel problems, mainly nausea and constipation. Tiredness and redness where the shot was given were also more common than on placebo.
Some problems, such as nausea, were more common in the higher dose groups. Others did not follow that pattern.
Each number is the share of people in a group who reported the problem during the trial. The middle column shows the lowest and highest share across the five cagrilintide dose groups. Placebo means a shot with no medicine in it. The tables show every problem in the posted results that reached 5% in a cagrilintide group. The first table shows those that reached 10%.
Phase 2 trial
Phase 2 weight trial (NCT03856047) Phase 2 · 26 weeks of treatment, side effects counted to week 32
706 adults without diabetes who had obesity, or overweight with high blood pressure or unhealthy blood-fat levels. 506 got cagrilintide and 101 got placebo. A liraglutide group of 99 is not shown.
| Reported problem | Cagrilintide groups | Placebo |
|---|---|---|
| Nausea | 19.8% to 46.5% | 17.8% |
| Constipation | 7.8% to 20.8% | 6.9% |
| Tiredness (fatigue) | 5.0% to 19.8% | 3.0% |
| Diarrhea | 6.9% to 17.6% | 8.9% |
| Redness where the shot was given | 4.0% to 16.8% | 0% |
| Less hunger | 4.0% to 16.8% | 4.0% |
| Colds (nose and throat infections) | 3.0% to 12.7% | 9.9% |
| Reactions where the shot was given | 4.0% to 11.8% | 0% |
| Headache | 5.0% to 10.8% | 11.9% |
Source for Phase 2 weight trial (NCT03856047): ClinicalTrials.gov posted results , posted .
10 less common problems in the trial results
Problems that reached 5% but not 10% in any cagrilintide group
Phase 2 weight trial (NCT03856047), less common problems Phase 2 · 26 weeks of treatment, side effects counted to week 32
The same trial and the same groups as the table above.
| Reported problem | Cagrilintide groups | Placebo |
|---|---|---|
| Dizziness | 2.0% to 8.9% | 3.0% |
| Vomiting | 4.9% to 8.8% | 3.0% |
| Urinary tract infections | 1.0% to 7.0% | 2.0% |
| Itching where the shot was given | 2.0% to 6.9% | 0% |
| Upper airway infections | 2.0% to 5.9% | 3.0% |
| Rash where the shot was given | 0% to 5.9% | 0% |
| Joint pain (arthralgia) | 1.0% to 5.9% | 6.9% |
| Upper belly pain | 1.0% to 5.9% | 3.0% |
| Bloated belly | 1.0% to 5.9% | 2.0% |
| Belly pain | 2.0% to 5.0% | 1.0% |
Source for Phase 2 weight trial (NCT03856047), less common problems: ClinicalTrials.gov posted results , posted .
Serious side effects
Serious side effects were reported in 2.0% to 6.9% of each cagrilintide group and 3.0% of the placebo group. The groups were small, so these counts cannot show whether cagrilintide caused them.
What these numbers do not show
- This was one 26-week trial of about 100 people per group. Trials this size can miss rare harms and harms that take years to appear.
- These numbers are for cagrilintide alone. They do not describe CagriSema, which combines cagrilintide with semaglutide.
- These numbers come from the trial medicine. They do not describe products sold online as research cagrilintide. FDA says cagrilintide is not part of any approved drug.
Report a side effect
You can report a suspected side effect to the FDA at 1-800-FDA-1088 or through FDA MedWatch . If a reaction feels serious, get medical care first.
Trial sources checked .
Fact checks
4 statements checked. Read what the results mean.
“Cagrilintide has human weight-loss evidence in defined studies.”
A phase 2 study examined cagrilintide alone. A later large study had separate cagrilintide-alone and CagriSema groups. The results apply only to each defined study group.
- What this answer is based on
- Health results from a study with randomly assigned groups
- Limits of this answer
- Adults without diabetes. The 26-week study required BMI 30 or higher, or BMI 27 or higher with high blood pressure or unhealthy blood-fat levels. The 68-week study required BMI 30 or higher, or BMI 27 or higher with a weight-related health problem. All groups received food and activity guidance. Each result applies only to its study group and period. The CagriSema result does not establish the same result for cagrilintide alone.
Sources for this fact check (2)
“Cagrilintide is FDA-approved.”
FDA's current page says cagrilintide is not a component of an approved drug and has not been found safe and effective for any condition. Human research does not equal FDA approval.
- What this answer is based on
- Official record or product label
- Limits of this answer
- United States regulatory status as reviewed August 30, 2026.
Sources for this fact check (1)
“CagriSema is cagrilintide alone.”
CagriSema is the investigational combination of cagrilintide and semaglutide. Evidence from the combination is not evidence for cagrilintide alone.
- What this answer is based on
- Health results from a study with randomly assigned groups
- Limits of this answer
- The separate cagrilintide-alone phase 2 and later CagriSema study reviewed here.
Sources for this fact check (2)
Show 1 more fact check
“Cagrilintide can be compounded under federal law.”
FDA's current unapproved-GLP-1 page says cagrilintide cannot be used in compounding under federal law. This is a United States status statement, not a finding that every online product is identical or safe.
- What this answer is based on
- Official record or product label
- Limits of this answer
- United States compounding status as reviewed August 30, 2026.
Sources for this fact check (1)
Questions people ask about Cagrilintide
In its phase 2 trial, the most common side effects were stomach and bowel problems, mainly nausea and constipation. ClinicalTrials.gov results show nausea in 19.8% to 46.5% of the cagrilintide groups and 17.8% on placebo. Tiredness and redness where the shot was given were also more common than on placebo. Cagrilintide is not FDA-approved, and its long-term risks are not known.
Risks and safety limits
An investigational molecule is not a self-treatment category. This guide does not provide trial-drug access, sourcing, dosing, injection, or combination instructions.
This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.
Reviewed .Check the rules for athletes ↗Terms used in the studies
- investigational
- still being studied and not approved for that use
- peptide
- a short chain of amino acids
- phase 2
- a mid-stage study in people that checks effects and safety before larger studies
- placebo
- an inactive treatment used for comparison
- molecule
- one specific chemical substance
- randomized
- assigned to study groups by chance
- outcome
- what the study measured
- compounded
- made for one patient by a pharmacy, or in batches by a permitted outsourcing facility; a compounded drug is not FDA-approved
Read the sources
Show 10 sources
Review history
Reviewed the cagrilintide-alone phase 2 study and the later large CagriSema study. Also reviewed a study that measured how the body processed and responded to cagrilintide given with semaglutide. Checked current study records and FDA's cagrilintide statement.
Not independently medically reviewed. This page is not a dosing, sourcing, or treatment guide.
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