Cagrilintide

Cagrilintide is a long-acting amylin analogue — a synthetic copy of a pancreatic hormone that quiets appetite — studied to help people lose weight, solo and as the amylin half of Novo Nordisk’s CagriSema. It isn’t FDA-approved yet, but unlike most research peptides the human proof is already here: it has cleared randomized trials and is well into Phase 3.

What is cagrilintide?

Cagrilintide is a lab-made, long-acting version of amylin, a hormone your pancreas squirts out alongside insulin every time you eat. Chemically it is a large peptide (molecular formula C194H312N54O59S2, molecular weight about 4,409 daltons, CAS 1415456-99-3), modified and attached to a fatty-acid chain so it sticks around in the body for roughly a week instead of minutes — which is what lets it be a once-weekly injection. One thing to get straight up front: cagrilintide is not a GLP-1 drug like semaglutide or tirzepatide. It works on a different hormone system entirely. It sits in this metabolic hub because its job is the same — weight loss — and because its most famous role is teaming up with a GLP-1 drug.

How does cagrilintide work?

Cagrilintide works by copying amylin, one of the body’s natural “you’re full” signals. Amylin is released with insulin after a meal and does three things: it slows how fast the stomach empties, it dials down appetite through the brainstem, and it tells the liver to ease off dumping sugar into the blood. Your own amylin breaks down within minutes. Cagrilintide is engineered to deliver that same message for about a week per dose, so the “I’ve had enough” feeling lingers.

Here’s the plain-English version of why CagriSema is interesting. If GLP-1 drugs like semaglutide are a longer-lasting copy of one gut “I’m full” hormone, then cagrilintide is a longer-lasting copy of a different one (amylin). CagriSema flips both switches at once — two separate appetite brakes instead of one — which is the whole rationale for combining them (cagrilintide + semaglutide in type 2 diabetes, ClinicalTrials.gov NCT04982575).

What does the research show?

Cagrilintide has real, randomized human evidence for weight loss — a sentence we can’t write about most peptides on this site. In earlier Phase 2 work, cagrilintide given on its own produced clearly greater weight loss than placebo over about six months, enough to push it into a Phase 3 monotherapy program (cagrilintide for weight loss, ClinicalTrials.gov NCT07220642). The bigger story is CagriSema, where cagrilintide is paired with semaglutide. In the Phase 3 REDEFINE 1 obesity trial, CagriSema produced average weight loss of roughly 22% of body weight over 68 weeks — among the largest figures reported in a Phase 3 obesity trial to date (REDEFINE 1, ClinicalTrials.gov NCT05567796). A parallel program tested it in type 2 diabetes (REDEFINE 2, ClinicalTrials.gov NCT05394519) and head-to-head against tirzepatide. In that 84-week REDEFINE 4 trial, CagriSema produced 23.0% weight loss versus 25.5% with tirzepatide when evaluating the treatment effect if all participants adhered to treatment, and it did not meet the primary endpoint of non-inferiority (Novo Nordisk REDEFINE 4 headline results), with a cardiovascular-outcomes study (REDEFINE 3) still running (ClinicalTrials.gov NCT05669755).

Two honest caveats keep this from being a victory lap. First, the headline ~22% comes from the combination, so it reflects semaglutide plus cagrilintide, not cagrilintide alone — teasing apart exactly how much the amylin half adds is still an active question. Second, the REDEFINE 1 topline landed a little below what some analysts had modeled, which is worth knowing even though ~22% is still a very large result. We grade cagrilintide’s weight-loss use Human RCT · helped — the evidence has arrived; what’s left is the long-term and comparative detail. (How we grade evidence: our evidence-grading method.)

Cagrilintide vs semaglutide and tirzepatide

Cagrilintide is usually discussed next to semaglutide and tirzepatide, but it plays a different position. Semaglutide (Wegovy/Ozempic) is a GLP-1 drug; tirzepatide (Zepbound/Mounjaro) is a dual GLP-1/GIP drug; cagrilintide is an amylin drug. On its own, cagrilintide’s weight-loss numbers are more in the range of first-generation GLP-1 dosing than the newer dual agonists — its real pitch is as a combination partner that adds a second, non-GLP-1 mechanism on top. That’s why the marquee comparison isn’t “cagrilintide vs semaglutide” so much as “CagriSema vs tirzepatide,” which REDEFINE tested directly. For the GLP-1 side of that matchup, see our semaglutide vs tirzepatide comparison, and the wider GLP-1 & metabolic peptides hub for how the whole category fits together.

Is cagrilintide safe? Side effects

Cagrilintide’s most common side effects are gastrointestinal — nausea, vomiting, diarrhea and constipation — much like the GLP-1 drugs it’s often given with, and usually worst while the dose is being ramped up. Injection-site reactions and reduced appetite (the intended effect, logged as a side effect) also show up. In trials these skew mild-to-moderate, but cagrilintide is still investigational, so long-term human safety data are limited and rare risks may not be fully characterized yet. Two practical points: amylin-class drugs can slow digestion enough to matter around procedures or with other stomach-affecting meds, and the cagrilintide sold as a “research chemical” powder online is unregulated — nothing vouches for its purity, its true dose, or its sterility, which is a real risk on top of the molecule itself.

FDA & legal status (2026)

Cagrilintide is not FDA-approved for any use as of 2026. It is an investigational drug in active Phase 3 trials run by Novo Nordisk, both alone and as the amylin part of CagriSema. Novo Nordisk submitted CagriSema’s NDA for weight management to FDA in December 2025, with a decision anticipated by late 2026 (Novo Nordisk). It is not a dietary supplement either. Separately, cagrilintide is sold on the research-chemical market labeled “for research use only,” which is not an approved medicine and not legal to sell for human consumption. The dated breakdown is in the regulatory status block above; the current registry picture is on ClinicalTrials.gov.

How is cagrilintide dosed and used?

In trials, cagrilintide is a once-weekly subcutaneous injection, with the dose raised gradually to limit nausea. Reported research doses run up to about 4.5 mg weekly for cagrilintide on its own, while CagriSema pairs 2.4 mg of cagrilintide with 2.4 mg of semaglutide at the top dose — these are doses reported in registered studies, not a recommendation or a personal protocol. Research-grade cagrilintide comes as a freeze-dried powder that has to be reconstituted with bacteriostatic water first; our reconstitution & dosing calculator turns “vial size, water added, target dose” into the exact syringe units, and the mixing-compatibility reference covers what people combine in one injection and where the honest answer is “not enough data.”

Frequently asked questions

Does cagrilintide actually work for weight loss?

Yes — in randomized human trials, cagrilintide produced more weight loss than placebo, and the CagriSema combination reached roughly 22% average weight loss over 68 weeks in Phase 3. That’s genuine human RCT evidence, not animal data. The main unknowns are long-term durability and how much cagrilintide adds on top of semaglutide by itself.

Is cagrilintide a GLP-1 drug like Ozempic?

No. Cagrilintide is an amylin analogue — a different hormone system from semaglutide (a GLP-1 drug). They’re grouped together because both curb appetite and drive weight loss, and CagriSema deliberately combines the two mechanisms.

Is cagrilintide legal or FDA-approved?

Cagrilintide is not FDA-approved and is not a dietary supplement. It’s an investigational drug in clinical trials. On the research-chemical market it’s sold “for research use only,” which is not legal to sell for human consumption.

Is cagrilintide banned in sport?

Cagrilintide isn’t named on the WADA prohibited list by name, but because it has no regulatory approval for human use it falls under WADA’s S0 “non-approved substances” class and is prohibited at all times (WADA 2026 Prohibited List).

What is CagriSema?

CagriSema is Novo Nordisk’s fixed combination of cagrilintide (the amylin drug) and semaglutide (the GLP-1 drug) in one weekly injection, developed for obesity and type 2 diabetes. It’s the reason most people have heard of cagrilintide at all.

Who is cagrilintide for — and who should be cautious?

Cagrilintide draws in people watching the next wave of weight-loss drugs — folks who’ve followed semaglutide and tirzepatide and want to know what’s coming behind them. The honest framing: cagrilintide is one of the few compounds on this site with real randomized human evidence for its headline use, and CagriSema’s Phase 3 numbers are large. But it isn’t approved, you can’t be prescribed it yet, the long-term data are still filling in, and the version sold online is an unregulated research powder with all the purity and sterility risks that implies. Anyone pregnant, managing significant GI disease, or unwilling to be an early adopter of an unapproved drug has every reason to wait for the approvals and the full trial readouts.