The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease

ClinicalTrials12 Mar 2026·Phase 3● 8/10i

The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease

Novo Nordisk A/S

Phase 3 cardiovascular outcomes trial evaluating CagriSema (cagrilintide + semaglutide 2.4 mg/2.4 mg) versus placebo in people with established cardiovascular disease. 7,101 participants enrolled with up to 4.5 years follow-up, measuring time to first 3-point MACE (cardiovascular death, non-fatal MI, non-fatal stroke). Novo Nordisk is testing whether their dual amylin/GLP-1 combination can deliver cardiovascular benefits beyond current GLP-1 monotherapy in high-risk populations. This represents the first major cardiovascular outcomes trial for a dual incretin/amylin combination therapy.

Strategic signal

CagriSema's cardiovascular outcomes data will determine whether Novo can defend against tirzepatide's dual-hormone advantage with its own combination approach. If positive, this positions CagriSema as a potential best-in-class obesity treatment with cardiovascular protection, supporting premium pricing and preferred formulary placement. The established CVD population mirrors Wegovy's recent MACE indication expansion, suggesting Novo is building a comprehensive cardiometabolic franchise around combination therapy.

GLP-1CardiovascularWeight lossNovo Nordisk

Original Abstract

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years. | Condition(s): Cardiovascular Disease | Primary endpoint(s): Time to first occurrence of 3-point major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke | Enrollment: 7,101 (actual) | Phase: Phase 3 | Sponsor: Novo Nordisk A/S | Expected completion: 2027-09-01 | Status: Active Not Recruiting | Last update: 2026-03-12

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