Under U.S. FDA review
CagriSema is Novo Nordisk's investigational fixed-dose combination of cagrilintide and semaglutide. It combines amylin- and GLP-1-pathway treatment in one once-weekly development product and is currently being reviewed by the FDA for chronic weight management.
Components
Cagrilintide + semaglutide
Primary pathways
Amylin + GLP-1
U.S. status
NDA under FDA review
Pivotal program
REDEFINE Phase 3
Important product distinction
The clinical evidence applies to a defined fixed-dose combination being developed by Novo Nordisk. A custom mixture of separately sourced cagrilintide and semaglutide is not the studied CagriSema product and should not be treated as clinically interchangeable with it.
Novo Nordisk submitted the CagriSema New Drug Application to the FDA on December 18, 2025 for long-term weight management in adults with obesity or overweight plus at least one weight-related comorbidity. The company says an FDA decision is anticipated in late 2026. Until FDA review is complete, CagriSema should be described as investigational rather than as an approved obesity medication.
REDEFINE 1
In the peer-reviewed REDEFINE 1 trial, 3,417 adults without diabetes were randomized to CagriSema, semaglutide, cagrilintide, or placebo. Using the treatment-policy estimand, mean weight change at 68 weeks was -20.4% with CagriSema versus -3.0% with placebo. Novo Nordisk's efficacy estimand, which models the effect if participants stayed on treatment, was about 23%.
REDEFINE 2
In adults with overweight or obesity and type 2 diabetes, peer-reviewed REDEFINE 2 reported a mean 68-week weight change of -13.7% with CagriSema versus -3.4% with placebo under the treatment-policy estimand, while also showing substantial glycemic improvement.
REDEFINE 4
The open-label Phase 3 REDEFINE 4 trial directly compared CagriSema 2.4/2.4 mg with tirzepatide 15 mg. Novo Nordisk reported 23% weight loss for CagriSema under the trial-product estimand, but the study did not meet its primary non-inferiority endpoint versus tirzepatide.
Safety context
Gastrointestinal adverse events such as nausea, vomiting, diarrhea, constipation, and abdominal discomfort are common in the CagriSema Phase 3 program and were generally reported as mild to moderate. Final U.S. product warnings and contraindications cannot be assumed before FDA review is complete.
BACToBasics does not treat CagriSema as a single research peptide or a generic mixed-vial recipe. The development program studies a fixed-dose combination product. Showing a custom CagriSema mixing calculator would blur an important distinction between the regulated clinical product and unverified mixtures, so this page focuses on evidence, regulatory status, and comparisons instead.
These comparison pages use the same standardized evidence fields so approved therapies, investigational compounds, and the CagriSema combination are not flattened into simple cross-trial weight-loss rankings.
No. Novo Nordisk submitted a U.S. New Drug Application for CagriSema weight management in December 2025, and the company says an FDA decision is anticipated in late 2026. As of the latest BACToBasics review, it remains investigational in the United States.
CagriSema is a fixed-dose combination of the long-acting amylin analogue cagrilintide and the GLP-1 receptor agonist semaglutide.
No. CagriSema produced substantial weight loss in the open-label Phase 3 REDEFINE 4 trial, but the study did not meet its primary endpoint of demonstrating non-inferiority versus tirzepatide 15 mg.
No. The clinical program studies a defined fixed-dose medicinal product. Separately sourced compounds, gray-market mixtures, and custom vial blends should not be treated as equivalent to the studied CagriSema product.
BACToBasics provides educational evidence summaries only. This page does not provide medical advice, dosing instructions, treatment recommendations, or instructions for preparing a CagriSema-like mixture.