This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.
Serum high-sensitivity C-reactive protein (hs-CRP) greater than 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 equal to 300 picograms per milliliter (pg/mL) at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NTproBNP must be greater than equal to 600 pg/mL. Note that the screening electrocardiogram (ECG) must be obtained the same day as sampling for NT-proBNP.
Hospitalisation or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than equal to 600 pg/mL.
Diagnosis of heart failure (New York Heart Association [classification] [NYHA] Class II-IV).
Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation, within 30 days prior to screening (visit 1).
Systolic blood pressure greater than equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than equal to 3 antihypertensive drugs. (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
Heart rate above 110 or below 40 beats per minute as evaluated on the electrocardiogram (ECG) performed at screening (visit 1) (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (Note: Planned coronary angiogram is not exclusionary).
Parallel
Ziltivekimab
DrugZiltivekimab subcutaneous (s.c.) injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years.
Placebo
DrugZiltivekimab placebo s.c. injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years.
Time to First Occurrence of a Composite Heart Failure Endpoint Consisting of: Cardiovascular (CV) Death, Heart Failure (HF) Hospitalisation or Urgent HF Visit
Measured in months.
Time to First Occurrence of 4-point Expanded Composite HF Endpoint, a Composite Endpoint Consisting of: CV Death, HF Hospitalisation or Urgent HF Visit, Non-fatal Myocardial Infarction (MI), Non-fatal Stroke
Measured in months.
Number of CV Deaths, HF Hospitalisations or Urgent HF Visits (First and Recurrent)
Measured as count of event.
Time to Occurrence of CV Death
Measured in months.
Time to Occurrence of all-cause Death
Measured in months.
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