Evidence brief
Cagrilintide
Written and source-checked by Anthony Treviso, founder of The Peptide Field.
Direct answer
Investigational in the United States; no FDA-approved cagrilintide product.
An investigational peptide made to act like the body's amylin signal. Human weight-loss studies exist, but no FDA-approved product exists.
- How strong is the evidence?
- Emerging
Some studies in people exist. Important questions remain about benefit, safety, who it helps, or how long the effects last. This is not an approval or recommendation. - What evidence exists?
- Investigational human outcomes
Studies measured health results in people, but the molecule is still being studied and is not approved for that use. Important questions remain. - Sports rules
- Not assessed
No current sports-rule review is available.
Reviewed August 30, 2026. Sources and update notes are below.
No sales or dosing advice. This guide explains research. It was not independently medically reviewed, and it does not diagnose, prescribe, or recommend treatment.
Also known as NNC0174-0833 · AM833 · NN9833
Part of Metabolic peptide medicines
Words used here
- investigational
- still being studied and not approved for that use
- peptide
- a short chain of amino acids
- outcome
- what the study measured
- molecule
- one specific chemical substance
- phase 2
- a mid-stage study in people that checks effects and safety before larger studies
- placebo
- an inactive treatment used for comparison
- randomized
- assigned to study groups by chance
- compounded
- made for one patient by a pharmacy, or in batches by a permitted outsourcing facility; a compounded drug is not FDA-approved
More detailProduct and study details
01 · Evidence profile
Four questions about the evidence
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.
02 · Identity
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.
Scientific group: Modified peptide based on amylin. This group name describes the type of molecule or body signal. It does not prove a benefit, safety, or approval.
03 · Exact product
The molecule is not the finished product.
Formulation: The finished product's ingredients and physical form. Route: How the product enters the body. Indication: The approved or studied use and group of people for a product.
None identified in the United States.
- Investigational weight-management programs
04 · Research results
What the research shows
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.
Exact product
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.
05 · Claim check
Claims I checked
4 claims checked for this brief.
“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.
- Evidence used
- Randomized human outcomes. This answer uses a study that assigned people to groups by chance and measured a health outcome.
- 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. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
“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.
- Evidence used
- Regulatory or product record. This answer uses an official regulator record or a specific product label.
- Limits of this answer
- United States regulatory status as reviewed August 30, 2026. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
“CagriSema is cagrilintide alone.”
CagriSema is the investigational combination of cagrilintide and semaglutide. Evidence from the combination is not evidence for cagrilintide alone.
- Evidence used
- Randomized human outcomes. This answer uses a study that assigned people to groups by chance and measured a health outcome.
- Limits of this answer
- The separate cagrilintide-alone phase 2 and later CagriSema study reviewed here. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
Show 1 more claim checks
“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.
- Evidence used
- Regulatory or product record. This answer uses an official regulator record or a specific product label.
- Limits of this answer
- United States compounding status as reviewed August 30, 2026. This answer covers only the named molecule and finished product. It also covers the product form and how people used it. The study limits include who took part, what was used for comparison, what changed, and how long the study lasted.
06 · Questions
Questions people ask about Cagrilintide
Investigational in the United States; no FDA-approved cagrilintide product. No approved product is identified in the United States.
Not assessed. This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body. This status is not personal clearance to compete.
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.
07 · Safety
Safety limits for this record
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.
No current sports-rule review is available.
Reviewed .Check current rules for tested sport ↗08 · Sources
Read the sources
09 · Review history
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.
Written and source-checked by Anthony Treviso, founder of The Peptide Field.
Not independently medically reviewed. This page is not a dosing, sourcing, or treatment guide.