Actively Recruiting
Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Led by Novo Nordisk A/S · Updated on 2026-03-11
5600
Participants Needed
1117
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.
CONDITIONS
Brief Title
A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Serum high-sensitivity C-reactive protein (hs-CRP) of 2 mg/L or higher at screening
- NT-proBNP level meeting specific thresholds based on presence of atrial fibrillation/flutter
- Hospitalization or urgent visit for decompensated heart failure with intravenous diuretic treatment within 9 months prior to screening
- Diagnosis of heart failure classified as NYHA Class II to IV
- Left ventricular ejection fraction greater than 40% documented by echocardiography within 12 months prior to or at screening
- Structural or functional heart disease documented by echocardiography with specific measurements such as left atrial volume or thickness
- No heart failure hospitalizations or urgent visits between screening and randomization
You will not qualify if you...
- Heart attack, stroke, unstable angina, transient ischemic attack, or heart failure hospitalization within 30 days prior to screening
- Systolic blood pressure of 180 mmHg or higher at screening; if 160-179 mmHg, must be on three or more antihypertensive drugs
- Heart rate above 110 or below 40 beats per minute at screening ECG
- Planned coronary, carotid, or peripheral artery revascularization during screening period
- Planned cardiac device implantation or atrial flutter/fibrillation ablation during screening
- Major cardiac, non-cardiac, or endoscopic surgery within 60 days prior to randomization or planned at randomization
- Heart failure due to specific cardiomyopathies or conditions such as sarcoid, amyloid, Takotsubo cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected valve disease
- Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD
- Other conditions that could explain heart failure symptoms like anemia or hypothyroidism
- Clinical evidence or suspicion of active infection at screening or per investigator's judgment
Research Team
N
Novo Nordisk
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