Review · United States
Cagrilintide
Reviewed on
Approval and product status
Investigational in the United States; no FDA-approved cagrilintide 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.
What was measured in people?
- Health results · Moderate
- Randomized studies measured body-weight changes in people who received cagrilintide alone or with semaglutide. Each result has its own study limits.
- Body changes · Moderate
- 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.
A change in a hormone or body signal does not by itself prove a health benefit.
Important limits
This tool is not an independent medical review. It does not recommend treatment.
An investigational molecule is not a self-treatment category. This guide does not provide trial-drug access, sourcing, dosing, injection, or combination instructions.
Still unknown: 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.
This record cannot check a package, seller, batch, or personal treatment. It does not provide sport clearance.
Approval fact checks
“Cagrilintide is FDA-approved.”
Misleading. 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.
Applies to: United States regulatory status as reviewed August 30, 2026.
“Cagrilintide can be compounded under federal law.”
Misleading. 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.
Applies to: United States compounding status as reviewed August 30, 2026.
Products in this review
These are selected records, not every product or form.
No product label record is included here. That is not a separate approval decision. Read the status and sources above.
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.
Read all Cagrilintide fact checksSources used in this review
A source may support some statements, not all of them. Use the links above or this review to see what each source supports.
Show 10 sources
- Cagrilintide for weight management: randomized phase 2 trial
PubMed · The Lancet · Randomized trial · 2021
Source accessed
- Coadministered cagrilintide and semaglutide in adults with overweight or obesity
PubMed · New England Journal of Medicine · Randomized trial · 2025
Source accessed
- FDA concerns with unapproved GLP-1 drugs used for weight loss
U.S. Food and Drug Administration · Regulatory · 2026
Source accessed
- Cagrilintide clinical study record
ClinicalTrials.gov · Trial registry · 2026
Source accessed
- Phase 2 cagrilintide study record (NNC0174-0833)
ClinicalTrials.gov · Trial registry · 2021
Source accessed
- AM833 pharmacology and cagrilintide identity
PubMed · Journal of Pharmacology and Experimental Therapeutics · Preclinical · 2021
Source accessed
- Development of Cagrilintide, a Long-Acting Amylin Analogue
PubMed · Journal of Medicinal Chemistry · Preclinical · 2021
Source accessed
- Cagrilintide with semaglutide: human exposure and effects
PubMed · The Lancet · Human pharmacology · 2021
Source accessed
- Q2 2026 research pipeline: NN9833 is cagrilintide
Novo Nordisk · Reference · 2026
Source accessed
- FDA substance record: cagrilintide identity (not an approval record)
U.S. Food and Drug Administration · Reference · 2026
Source accessed