Also known as: cagrilintide/semaglutide · cagrilintide + semaglutide · cagrilintide-semaglutide
Human RCTHelped
On this page
- What is CagriSema?
- How does CagriSema work?
- What does the research show?
- Is CagriSema safe? Side effects
- FDA & legal status (2026)
- How is CagriSema dosed in studies?
- CagriSema vs tirzepatide and semaglutide
- Frequently asked questions
- Who is CagriSema for — and what to watch
- Evidence by outcome
- FDA & legal status
- Registered clinical trials
- Reported side effects
- Chemical identifiers
- References
- Related compounds
- More on CagriSema
CagriSema is Novo Nordisk’s investigational weekly injection that combines two appetite-lowering gut-hormone drugs — semaglutide (a GLP-1 receptor agonist) and cagrilintide (an amylin analog) — studied mainly for weight loss and type 2 diabetes. In large human trials CagriSema drove substantial weight loss. It is not yet FDA-approved.
What is CagriSema?
CagriSema is one drug made of two: it packs cagrilintide and semaglutide into a single fixed-dose, once-weekly injection. Semaglutide is the same GLP-1 molecule inside Ozempic and Wegovy; cagrilintide is a longer-acting version of amylin, a hormone your pancreas releases alongside insulin. Novo Nordisk’s bet is that stacking two different “stop eating” signals in one pen beats either one alone. Unlike the research peptides elsewhere on this site, CagriSema isn’t a gray-market powder — it’s a pharmaceutical candidate tested in tens of thousands of people across the REDEFINE Phase 3 program.
How does CagriSema work?
CagriSema works by firing two separate appetite brakes at the same time. Think of hunger as a house with two independent alarm systems: semaglutide trips the GLP-1 alarm (slowing how fast your stomach empties and signaling fullness to the brain), while cagrilintide trips the amylin alarm (a different satiety pathway your body normally uses after a meal). Because GLP-1 and amylin act through different receptors, CagriSema layers their effects rather than duplicating them — the logic behind combining them instead of just giving more semaglutide. Semaglutide also nudges the pancreas to release insulin when blood sugar is high, which is why CagriSema is studied for diabetes as well as weight (REDEFINE 2, NCT05394519).
What does the research show?
CagriSema’s evidence is unusually strong for a compound this new, because it went straight into large human randomized trials. In the REDEFINE 1 obesity trial — roughly 3,400 adults over 68 weeks — CagriSema produced about 22% average body- weight reduction versus around 2% on placebo (NCT05567796). That is a big number in absolute terms, but it’s worth being honest: it came in below the ~25% Novo Nordisk had publicly signaled, and only a minority of participants actually reached the highest dose, which dented the headline. In type 2 diabetes, REDEFINE 2 showed CagriSema lowering both HbA1c and weight against placebo, with additional Phase 3 trials pitting CagriSema directly against semaglutide and tirzepatide (NCT05394519). What’s not in yet: the cardiovascular-outcomes trial (REDEFINE 3) is still running, so CagriSema’s effect on heart attacks and strokes is an open question (NCT05669755). Every CagriSema trial to date is sponsored by Novo Nordisk, its maker — worth noting when you read the results.
Is CagriSema safe? Side effects
CagriSema’s most common side effects are gastrointestinal — nausea, vomiting, diarrhea, and constipation — the same profile you’d expect from any GLP-1 or amylin drug, and mostly clustered during the weeks when the dose is being increased. Because CagriSema has been through Phase 3 trials in thousands of people, its safety picture is far more complete than the animal-only research peptides on this site; the trials generally reported these GI effects as mild to moderate and a common reason some people stopped (NCT05567796). The honest gaps: long-term (multi-year) safety is still accumulating, the full cardiovascular-safety readout isn’t published, and — as with all GLP-1 drugs — rapid weight loss brings its own considerations around muscle loss and nutrition. CagriSema is not something to combine with other GLP-1 or amylin drugs.
FDA & legal status (2026)
CagriSema is not FDA-approved for any use as of 2026 — it is an investigational drug, not a supplement and not a research chemical you’d buy in a vial. Novo Nordisk completed the core REDEFINE Phase 3 program in obesity and diabetes and is expected to seek regulatory approval, but until an approval is actually granted, CagriSema isn’t legally available as a prescription product in the United States. This status is in motion, so treat any “it’s approved now” claim with suspicion and re-check the dated status block below against openFDA (Drugs@FDA). Be especially wary of anyone selling “CagriSema” today — an unapproved, un-branded combination sold outside the trials is not the studied product.
How is CagriSema dosed in studies?
CagriSema is given as a once-weekly subcutaneous injection in the trials, using a fixed-dose pen that escalates gradually to let the gut adjust — the slow titration is exactly what keeps the nausea manageable. We’re describing what the published trials used, not a protocol for you to follow: CagriSema is investigational, the exact strengths are set by the manufacturer’s pen, and there is no self-dosing version of this drug. Because it ships as a ready-to-use pen rather than a freeze-dried powder, the reconstitution math that matters for research peptides doesn’t apply here — if you’re comparing the economics of the approved GLP-1 drugs instead, our cost-per-dose tool is the relevant one.
CagriSema vs tirzepatide and semaglutide
CagriSema, tirzepatide, and semaglutide are the headline names in the weight-loss drug race, and they take different routes to the same goal. Semaglutide is a single GLP-1 agonist; tirzepatide (Mounjaro/Zepbound) is a dual GLP-1 and GIP agonist; CagriSema pairs GLP-1 with amylin. Novo Nordisk has run CagriSema head-to-head against both, which is the fairest way to judge it — no single molecule is the universal winner, and the right pick depends on the goal, tolerability, and what’s actually approved. For the two drugs you can be prescribed today, start with our semaglutide vs tirzepatide comparison, and see the whole GLP-1 and metabolic peptide hub for how these compounds relate.
Frequently asked questions
Does CagriSema work for weight loss?
Yes — in human randomized trials CagriSema produced large weight loss, roughly 22% of body weight over 68 weeks in the REDEFINE 1 obesity study versus about 2% on placebo. That’s a strong result, though it fell short of the ~25% Novo Nordisk had signaled, and long-term durability is still being studied.
Is CagriSema FDA-approved?
No. CagriSema is not FDA-approved as of 2026; it is an investigational drug that has completed its core Phase 3 trials, with regulatory filings anticipated. It is not a supplement and not legally sold as a prescription product yet — re-verify the status before assuming otherwise.
What is CagriSema made of?
CagriSema is a fixed-dose combination of two peptides: semaglutide, a GLP-1 receptor agonist (the molecule in Ozempic and Wegovy), and cagrilintide, a long-acting amylin analog. The idea is to combine two different appetite-suppressing hormone pathways in one weekly injection.
How is CagriSema taken?
In the trials, CagriSema is a once-weekly subcutaneous injection from a fixed-dose pen, with the dose escalated slowly over several weeks to reduce nausea. There is no approved self-dosing version — everything known about how it’s used comes from the Novo Nordisk trials.
Is CagriSema banned in sport?
GLP-1 receptor agonists and amylin analogs are not currently on WADA’s Prohibited List, so CagriSema is not a prohibited class as of 2026. Anti-doping rules are updated yearly, though, so any competing athlete should confirm against the current WADA list.
CagriSema vs tirzepatide — which is stronger?
There’s no clean universal winner. CagriSema (GLP-1 + amylin) and tirzepatide (GLP-1 + GIP) have been compared head-to-head in Novo Nordisk trials, and which one edges ahead depends on the specific outcome, dose reached, and tolerability. Both produce large weight loss; tirzepatide is already FDA-approved, while CagriSema is not.
Who is CagriSema for — and what to watch
CagriSema draws in the person who’s already lost weight on semaglutide or tirzepatide, hit a plateau, and heard the “next-generation” combo might push further. The honest framing: CagriSema is one of the best-evidenced compounds we cover — real Phase 3 human trials, large weight loss, a substantial safety record — which is a completely different tier of proof than the animal-only research peptides elsewhere on this site. But it isn’t approved, it isn’t something to source outside a trial, its headline result slightly underwhelmed expectations, and its cardiovascular-outcomes data isn’t in yet. The thing to watch through 2026 is regulatory: whether and when it’s approved, and how the REDEFINE 3 heart-outcomes trial reads out.
Evidence by outcome
Each outcome CagriSema has been studied for, with the honest evidence grade and what the studies actually found. A tier never stands alone — the verdict rides with it.
| Outcome | Evidence | What was found |
|---|---|---|
| Weight loss / obesity | Human RCTHelped | CagriSema has been tested in large randomized Phase 3 trials in people with obesity (the REDEFINE program). In the flagship 68-week obesity trial, CagriSema produced roughly 22% average weight loss versus about 2% on placebo — a large effect, though it landed below the ~25% Novo Nordisk had publicly guided toward, partly because many participants never reached the top dose. |
| Type 2 diabetes (blood-sugar control) | Human RCTHelped | In randomized Phase 3 trials in adults with type 2 diabetes, CagriSema lowered both blood sugar (HbA1c) and body weight versus placebo, and was also compared head-to-head against semaglutide alone and tirzepatide. The full head-to-head readouts feed directly into how it's positioned against the drugs already on pharmacy shelves. |
FDA & legal status
- United States: investigational (as of Jul 2026)
Not FDA-approved for any use as of 2026. CagriSema is Novo Nordisk's investigational fixed-dose combination; its Phase 3 REDEFINE program in obesity and type 2 diabetes is largely complete, with regulatory filings anticipated and a cardiovascular-outcomes trial still running. Because status is moving, re-verify against openFDA and Novo Nordisk announcements.
openFDA Drugs@FDA lists no approved product for CagriSema as of 2026-07-15.
Registered clinical trials
30 registered studies mention CagriSema on ClinicalTrials.gov (latest update 2026-07-17). A registered trial means a study is planned or underway — not that CagriSema is approved or proven.
Reported side effects
| Effect | Frequency | Severity |
|---|---|---|
| Nausea | Common | Usually mild-to-moderate, most frequent during dose escalation |
| Vomiting and diarrhea | Common | Usually mild-to-moderate, gastrointestinal |
| Constipation | Common | Usually mild-to-moderate |
| Decreased appetite | Common | Expected pharmacologic effect |
Chemical identifiers
External database IDs are not yet verified for CagriSema, so we omit them rather than guess. A wrong identifier is worse than none.
References
- 1.CagriSema — indexed research (PubMed, National Library of Medicine)
- 2.REDEFINE 1 — CagriSema in people with obesity (NCT05567796, ClinicalTrials.gov)
- 3.REDEFINE 2 — CagriSema in type 2 diabetes and excess weight (NCT05394519, ClinicalTrials.gov)
- 4.REDEFINE 3 — CagriSema cardiovascular outcomes trial (NCT05669755, ClinicalTrials.gov)
- 5.CagriSema registered clinical studies (ClinicalTrials.gov search)
- 6.FDA — Drugs@FDA (regulatory status lookup)
More on CagriSema
Everything else we've written about CagriSema — what the community reports, the explainers that cover it, and the terms it keeps running into.
- CagriSema Reddit: Results, Sides & TimelineOn Reddit
- Primary endpointGlossary