Cagrilintide (part of CagriSema)

A new weekly amylin shot. Mixed with semaglutide as CagriSema, it is waiting for an FDA decision. It is not approved yet.

AI illustration of a vial labeled Cagrilintide — AI illustration

FDA statusIn testing

Still in clinical trials. Not FDA approved yet.

Proof it works in people for weight loss (as CagriSema)Strong

A trial of more than 3,400 people.

Safety data in peopleLimited

Big trial, but not yet reviewed and approved by the FDA.

These are 3 different questions. FDA status is about the law. Proof is about whether it works. Safety data is about how much we know about its risks. A lack of safety data does not mean it does not work, and "not approved" does not mean "illegal."

By the Peptide Science Desk Editorial TeamFact-checked against FDA and official sources · Oct 18, 2026Not yet reviewed by a licensed clinician. How we check facts

What is it?

Cagrilintide is a lab-made peptide made by Novo Nordisk. It acts like amylin, a hormone that helps you feel full. CagriSema is cagrilintide plus semaglutide (the medicine in Wegovy) in one weekly shot.

Why do people use it?

People are excited because big tests showed large weight loss.

Does it really work?

In a 68-week study of 3,417 adults with obesity or overweight, people on CagriSema lost about 20% of their body weight on average. People on a fake shot (placebo) lost about 3%. Novo Nordisk asked the FDA to approve CagriSema in December 2025. As of October 18, 2026, the FDA has not decided.

Studies in people

Study	People	What they found	Limits
Randomized trial (REDEFINE 1)	3,417	Lost 20.4% on CagriSema vs 3.0% on placebo in 68 weeks.	Paid for by the maker. Stomach side effects in about 80%.

We only list studies we read on PubMed or ClinicalTrials.gov. Checked October 18, 2026.

The numbers in a chart

Newer weight-loss drugs still in testing

Change in body weight, drug vs placebo. A minus sign means weight lost

Retatrutide 12 mgIn testingTRIUMPH-1 · 2,339 adults · 80 weeks

−25.0%

−3.9%

CagriSema (cagrilintide + semaglutide)In testingREDEFINE 1 · 3,417 adults · 68 weeks

−20.4%

−3.0%

Mazdutide 6 mgIn testingGLORY-1 · 610 adults in China · 48 weeks

−14.0%

+0.3%

Survodutide 6.0 mgIn testingSYNCHRONIZE-1 · 725 adults · 76 weeks

−13.0%

−5.4%

Different trials, different people: not a head-to-head comparison. None of these is FDA approved.

Show the numbers as a table

Newer weight-loss drugs still in testing: Change in body weight, drug vs placebo. A minus sign means weight lost
Trial	Drug	Placebo
Retatrutide 12 mg (In testing) TRIUMPH-1 · 2,339 adults · 80 weeks	−25.0%	−3.9%
CagriSema (cagrilintide + semaglutide) (In testing) REDEFINE 1 · 3,417 adults · 68 weeks	−20.4%	−3.0%
Mazdutide 6 mg (In testing) GLORY-1 · 610 adults in China · 48 weeks	−14.0%	+0.3%
Survodutide 6.0 mg (In testing) SYNCHRONIZE-1 · 725 adults · 76 weeks	−13.0%	−5.4%

The striped bar means the placebo group gained a little weight (+0.3%). Each trial was paid for by the drug maker. Trial lengths are not the same. Sources: Jastreboff et al., NEJM 2026 (TRIUMPH-1) (PMID 42814954); Garvey et al., NEJM 2025 (REDEFINE 1) (PMID 40544433); Ji et al., NEJM 2025 (GLORY-1) (PMID 40421736); le Roux et al., NEJM 2026 (SYNCHRONIZE-1) (PMID 42253238).

More charts: Peptides by the numbers

Is it safe? Side effects

In the big study, about 8 in 10 people on CagriSema had stomach problems like feeling sick, throwing up, diarrhea, constipation, or belly pain. About 4 in 10 on the fake shot did too. Most cases were mild to medium and went away.
The FDA warns that unapproved GLP-1 type drugs sold online may be fake or unsafe.

Is it legal in the US?

No. Cagrilintide and CagriSema are not FDA-approved yet. (The FDA is the US agency that checks if medicines are safe and work.) Right now you can only get them legally in an approved clinical trial.

What "not approved" does and does not mean

"Not FDA approved" is not the same thing as "illegal." It means the FDA has not reviewed proof that it works and is safe.
Outside the narrow pharmacy rules below, selling it as a medicine for people breaks federal law. The FDA has warned companies that sold unapproved drugs labeled "for research" or "not for human consumption" to people. (FDA)
A regular pharmacy may only mix (compound) a drug from a raw ingredient that has an official quality standard, is part of an FDA-approved drug, or is on the FDA’s 503A list. Big "outsourcing" pharmacies (503B) have their own list. (FDA)
The FDA says that in most cases it is illegal for people to bring unapproved drugs into the US for their own use. (FDA)
State rules differ. State boards of pharmacy oversee most pharmacies day to day. Sports leagues and the military have their own bans. (FDA)

Banned in sports? Drug tests

Likely banned in sports.

Cagrilintide is not named on WADA's list. But it is still a test drug and not approved anywhere. WADA's S0 rule bans drugs "under clinical development" with no approval, at all times. From Jan 1, 2027, that rule also names "peptides."

Check work, NCAA, and military rules for Cagrilintide

Talk to your doctor

Do not start any peptide on your own. Ask a doctor first. We never share doses or tell you where to buy. Print our doctor questions sheet.

Check any peptide in 1 secondFree FDA Status Checker: approved, being tested, or not proven.

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Not medical advice. Medical disclaimer.