Effects of Ziltivekimab Versus Placebo on Heart Failure Symptoms and Physical Function in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Novo Nordisk A/S
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugZiltivekimab
Zilitivekimab will be administered subcutaneously once-monthly.
- DrugPlacebo
Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.
Locations (240)
- Advanced Cardiovascular, LLCAlexander City, Alabama
- Eastern Shore Rsrch Inst, LLCFairhope, Alabama
- Cardiology & Medicine ClinicLittle Rock, Arkansas
- Valley Clinical Trials, Inc.Northridge, California
- Valley Clinical Trials, Inc.Northridge, California
- UCI HealthOrange, California