An investigational once-weekly amylin analog from Novo Nordisk, studied alone and with semaglutide as CagriSema. Not approved.
Also called AM833, Cagri, CagriSema (combined with semaglutide)
Cagrilintide is a long-acting copy of amylin, a hormone your pancreas releases with insulin after meals that makes you feel full and slows stomach emptying. Natural amylin clumps into fibrils and lasts minutes; the older drug pramlintide needs three injections a day. Cagrilintide is stabilized and carries a fatty acid tail, so it lasts about a week. It also activates calcitonin receptors, so it is often called a nonselective amylin analog.
On its own it works, but less than semaglutide. In a 26-week phase 2 trial in 706 adults, 4.5 mg weekly gave 10.8% weight loss against 3.0% on placebo and 9.0% on daily liraglutide. In the cagrilintide-only arm of REDEFINE 1, 2.4 mg gave 11.5% weight loss at 68 weeks counting everyone randomized. The bigger story is the combination: CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) averaged 20.4% in REDEFINE 1 and 13.7% in people with type 2 diabetes in REDEFINE 2.
Neither cagrilintide nor CagriSema is approved as of October 2026. Novo Nordisk filed CagriSema with the FDA in December 2025 and expects a decision in late 2026. In February 2026 CagriSema failed to show it was as good as tirzepatide 15 mg in the REDEFINE 4 head-to-head trial. A separate phase 3 program for cagrilintide alone (RENEW) started in late 2025.
What it binds to, and what happens inside the body after that, step by step.
Cagrilintide activates amylin receptors, which are calcitonin receptors paired with receptor activity-modifying proteins, and it also activates the calcitonin receptor itself. These receptors sit in the area postrema and other brainstem sites that signal fullness. The result is smaller meals, slower stomach emptying and lower glucagon after meals. Because this pathway is separate from GLP-1, the two can be combined for more weight loss.
Human results and animal results are kept apart below. A result in rats tells you a mechanism is plausible. It does not tell you what happens in a person.
As a single drug, cagrilintide has one dedicated phase 2 RCT and a monotherapy arm inside the phase 3 REDEFINE 1 trial, both showing about 11% weight loss, with GI side effects milder than GLP-1 drugs. As part of CagriSema, it has several large phase 3 RCTs showing about 20% weight loss in people without diabetes. There are no outcome data on heart attacks or death yet; the REDEFINE 3 cardiovascular trial is ongoing.
3,417 adults with obesity or overweight, no diabetes
CagriSema gave -20.4% weight change at 68 weeks vs -3.0% on placebo; GI side effects affected 79.6% vs 39.9%, mostly temporary and mild to moderate.
Read the study706 adults with obesity or overweight, no diabetes
Weight loss at 26 weeks ranged from 6.0% (0.3 mg) to 10.8% (4.5 mg) vs 3.0% on placebo and 9.0% on liraglutide 3.0 mg.
Read the study1,206 adults with obesity or overweight and type 2 diabetes
Weight change at 68 weeks was -13.7% on CagriSema vs -3.4% on placebo; 73.5% reached HbA1c of 6.5% or less.
Read the studyCagrilintide 2.4 mg and placebo arms of REDEFINE 1
Weight change was -11.5% vs -3.0% on placebo counting everyone randomized (-11.8% vs -2.3% if fully adherent); 31% lost at least 15%.
Read the study95 healthy adults with overweight or obesity
Cagrilintide half-life was 159 to 195 hours; at 20 weeks, cagrilintide 2.4 mg plus semaglutide gave 17.1% weight loss vs 9.8% on semaglutide plus placebo.
Read the study809 adults with obesity, open-label
CagriSema gave 23.0% vs 25.5% on tirzepatide 15 mg at 84 weeks (adherent analysis) and missed its non-inferiority goal.
Read the studyNo preclinical studies are listed as key studies here. The human data above carries the evidence.
These are questions the published research has not answered.
No product containing Cagrilintide is approved as a medicine by the FDA.
Phase 3. CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) was submitted to the FDA on December 18, 2025 for weight management; no FDA decision had been announced as of October 13, 2026. Cagrilintide alone is in the phase 3 RENEW program, planned to start in Q4 2025. WADA: not named on the Prohibited List, but as a substance with no government approval for human use it falls under section S0 (non-approved substances), which is prohibited at all times. This is our reading of the S0 rule, not a WADA ruling on cagrilintide by name.
How much of Cagrilintide is left after a single dose
Simple first-order model from the published half-life. Real clearance varies with dose, route, kidney and liver function and formulation. This is not a dosing schedule.
This table records the doses that trials and approved labels used, with the source for each row. It is a record of research, not a recommendation, and it is open to free members.
Which symptoms are expected and which mean stop and get help: side effects and red flags.
Tap a claim to see what the studies found.
In REDEFINE 1, cagrilintide 2.4 mg alone gave about 11.5% weight loss at 68 weeks. Semaglutide 2.4 mg alone gave 14.9% over the same 68 weeks in STEP 1. The two have not been compared head to head in a trial designed for that question.
In REDEFINE 4, an 84-week head-to-head trial in 809 adults, CagriSema gave 23.0% vs 25.5% for tirzepatide 15 mg and missed its non-inferiority goal.
Novo reports GI effects with cagrilintide alone that were mostly mild, and discontinuation for nausea was 1.0%. But nausea still affected 20% to 47% in phase 2, and no head-to-head tolerability trial against a GLP-1 drug has been published.
CagriSema was tested only as cagrilintide plus semaglutide at matched doses under trial supervision. Mixing unapproved vials with a different drug has never been studied, and research chemicals have no verified content.
These pairings come up often. Almost none have been tested together in a trial, and the evidence note on each says so plainly.
Amylin and GLP-1 cut appetite through separate brain pathways, so combining them adds weight loss.
EvidencePhase 3 evidence: 20.4% average weight loss in REDEFINE 1 and 13.7% in type 2 diabetes in REDEFINE 2. Under FDA review; not approved as of October 2026.
Discussed online as a home-made version of an amylin plus incretin combination.
EvidenceNo published human study. All human combination data use semaglutide.
Discussed online for maximum weight loss.
EvidenceAnimal data only: a 2026 study in obese male rats reported added weight loss. Never tested in humans.
No approved product exists. Trial supply is a ready-to-use solution handled under the sponsor's protocol. Storage claims for research-chemical powders are vendor statements, not tested data.
Not established outside clinical trials.
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