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Investigating how ziltivekimab affects heart failure and inflammation

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

Phase 3 Interventional Novo Nordisk A/S · NCT06200207

This study is testing a new medication called ziltivekimab to see if it can help people with heart failure and inflammation feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment680 (estimated)
Ages18 Years and up
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Drugs / interventionsziltivekimab
Locations240 sites (Alexander City, Alabama and 239 other locations)
Trial IDNCT06200207 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy of ziltivekimab, a new medication, in treating participants with heart failure and systemic inflammation. Participants will be randomly assigned to receive either ziltivekimab or a placebo, allowing researchers to compare the effects of the active drug against an inactive substance. The study is designed to last for up to 1 year and 4 months, focusing on specific cardiovascular biomarkers to determine eligibility. Ziltivekimab is not yet approved for use, making this trial crucial for understanding its potential benefits.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with heart failure (NYHA Class II-III) and elevated levels of inflammation markers.

Not a fit: Patients with heart failure who do not meet the specific inclusion criteria or have other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from heart failure and inflammation.

How similar studies have performed: While ziltivekimab is a novel approach, similar studies targeting inflammation in heart failure have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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 at screening (visit 1) showing at least one of the following:

  1. Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m\^2)
  2. LA diameter greater than or equal to 3.8 centimeter (cm)
  3. LA length greater than or equal to 5.0 cm
  4. LA area greater than or equal to 20 square centimeter (cm\^2)
  5. LA volume greater than or equal to 55 milliliter (mL)
  6. Intraventricular septal thickness greater than or equal to 1.1 cm
  7. Posterior wall thickness greater than or equal to 1.1 cm
  8. LV mass index greater than or equal to 115 gram per square meter (g/m\^2) in men or greater than or equal to 95 g/m\^2 in women

  h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and lateral) less than 9 centimeter per second (cm/s)
* No heart failure hospitalisations or urgent heart failure visits between screening and randomisation
* Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres
* Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening

Exclusion Criteria:

* Medical conditions - cardiovascular:
* 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 or 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 or equal to 3 antihypertensive drugs
* Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1)
* Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
* Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
* Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
* Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease (COPD)
* Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism)
* Medical conditions - infections/immunosuppression:
* Clinical evidence of, or suspicion of, active infection at the discretion of the investigator

Where this trial is running

Alexander City, Alabama and 239 other locations

+190 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureSystemic Inflammation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.