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Recruiting Phase 3 NCT06200207

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

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Trial Parameters

Condition Heart Failure
Sponsor Novo Nordisk A/S
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 680
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04-01
Completion 2026-10-01
Interventions
ZiltivekimabPlacebo

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Brief Summary

The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.

Eligibility Criteria

Inclusion Criteria: * Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1) * Disease specific - cardiovascular: * N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 picograms per milliliter (pg/mL) (375 pg/mL for participants with atrial fibrillation/flutter) at screening * Diagnosis of heart failure (New York heart association (NYHA) Class II-III) * Left ventricular ejection fraction (LVEF) greater than 40 percent documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (example myocardial infarction (MI) or heart failure (HF) hospitalisation) * Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or a

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