CagriSema Reference
Educational, not medical advice reference for CagriSema: GLP-1, Fat Loss; regulatory status, evidence posture, source review, and schedule notes…
Plain English
- What it is
- CagriSema is an experimental once-a-week injection being developed by Novo Nordisk for weight loss. It puts two medicines in one shot: semaglutide (the GLP-1 medicine also found in Wegovy and Ozempic) and cagrilintide (a long-acting copy of a natural appetite hormone called amylin). It is still being tested and is not an approved drug.
- What people use it for
- It is being developed as a possible next-generation weight-loss treatment for adults with obesity, including some who also have type 2 diabetes. In the peptide and GLP-1 community it is often talked about as Novo Nordisk's planned follow-up to Wegovy. Because it is still experimental, it cannot be prescribed and is not available to buy.
- What the science shows
- Large, late-stage human trials (REDEFINE-1 and REDEFINE-2) tested it for more than a year and found much greater average weight loss than a placebo (dummy) shot. The most common problems were stomach-related, such as nausea, vomiting, and diarrhea, which were usually mild to moderate. A key open question is whether the extra weight loss is worth these added stomach side effects.
- The catch
- CagriSema is investigational, which means regulators have not approved it. Novo Nordisk asked the U.S. FDA to approve it in late 2025, but it is not approved in the US or EU and is not sold in pharmacies. Anything offered for sale online as CagriSema is not the approved, studied medicine.
Reference summary
REDEFINE-1 (Garvey 2025 NEJM, n=3,417 adults with obesity, 68 weeks) reported placebo-subtracted weight reductions consistent with a meaningful clinical effect; the primary 68-week mean weight change was greater for CagriSema than for semaglutide monotherapy or cagrilintide monotherapy alone, but the magnitude was smaller than the originally guided Novo Nordisk target prior to the readout. REDEFINE-2 (Davies 2025 NEJM) ran the same combination in adults with type 2 diabetes plus obesity. Adverse events were dose-dependent gastrointestinal (nausea, diarrhea, vomiting) consistent with both component classes; tolerability was the principal practical limitation versus monotherapy semaglutide.
Regulatory and posture
- Categories
- GLP-1, Fat Loss
- Aliases
- Cagrilintide + semaglutide fixed-dose combination, CagriSema 2.4 mg / 2.4 mg, Amylin analog (cagrilintide) + GLP-1 (semaglutide)
- Evidence posture
- human - REDEFINE-1 and REDEFINE-2 Phase 3 data exist and Novo Nordisk filed the FDA NDA in December 2025, but CagriSema remains investigational pending FDA review.
- Regulatory status
- Investigational fixed-dose combination of cagrilintide (long-acting amylin analog) and semaglutide. Novo Nordisk filed the FDA NDA in December 2025; not approved in the US or EU as of the data check date.
- Content review status
- investigational verified
Selected public sources
- Novo Nordisk CagriSema FDA filing announcement
- PubMed: Garvey et al. N Engl J Med 2025 - coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE-1, Phase 3) (PMID 40544433)
- PubMed: Davies et al. N Engl J Med 2025 - cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE-2, Phase 3) (PMID 40544432)
- FDA concerns with unapproved GLP-1 drugs
Related tools
- Semaglutide dose calculator - Run semaglutide-focused vial draw math.
- GLP-1 conversion calculator - Convert a GLP-1 mg dose to U-100 units and ml.
- GLP-1 ramp planner - Preview a linear educational dose-step table.
- Peptide half-life calculator - Estimate single-dose decay from cited half-life constants.
- PK simulator overview - Public overview of the Pro pharmacokinetic simulator.
- GLP-1 taper planner overview - Public overview of the Pro GLP-1 taper planner.
For research and educational purposes only. Not medical advice.