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

Purpose

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.

Conditions

  • Heart Failure
  • Systemic Inflammation

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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 (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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Ziltivekimab 		Participants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months.
  • Drug: Ziltivekimab
    Zilitivekimab will be administered subcutaneously once-monthly.
Placebo Comparator
Placebo 		Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months.
  • Drug: Placebo
    Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.

Recruiting Locations

Advanced Cardiovascular, LLC
Alexander City, Alabama 35010

Eastern Shore Rsrch Inst, LLC
Fairhope, Alabama 36532

Cardiology & Medicine Clinic
Little Rock, Arkansas 72204

Valley Clinical Trials, Inc.
Northridge, California 91325

UCI Health
Orange, California 92868

South California Heart Spc
Pasadena, California 91105

Clearwater Cardiovascular Consultants
Largo, Florida 33777

Ocala Cardiovascular Research
Ocala, Florida 34471

Ormond Beach Clinical Research
Ormond Beach, Florida 32174

St Johns Ctr Clin Rsch-St. Aug
Saint Augustine, Florida 32086

GA Arrhythmia Cons & Rsch Inst
Macon, Georgia 31201

Velocity Clin Rsrch - Savannah
Savannah, Georgia 31406

Chicago Medical Research LLC
Hazel Crest, Illinois 60429

UofL Health Care Outpatient
Louisville, Kentucky 40202

Maryland Cardiovascular Specialists - Baltimore
Baltimore, Maryland 21229

Cardio and Vascular Assoc-CAVA
Bloomfield Hills, Michigan 48304

Millennium Cardiology
Farmington Hills, Michigan 48334

Kansas City VA Medical Center
Kansas City, Missouri 64128

Washington University
Saint Louis, Missouri 63110

Renown Regional Medical Center
Reno, Nevada 89502

Mount Sinai Hosp at NYC
New York, New York 10019

Northwell Health Phys Cardio
Riverhead, New York 11901

University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina 27599-7046

AMS Cardiology
Horsham, Pennsylvania 19044

University of Pennsylvania Hospital
Philadelphia, Pennsylvania 19104

PharmaTex Research
Amarillo, Texas 79106

University of Texas Southwestern Medical Center
Dallas, Texas 75390-9302

David Turbay, MD, PLLC
El Paso, Texas 79905

Clinical Advancement Ctr, PLLC
San Antonio, Texas 78212

Sherman Clinical Research
Sherman, Texas 75092

Northwest Heart Center
Tomball, Texas 77375

Virginia Commonwealth University
Richmond, Virginia 23298

More Details

NCT ID
NCT06200207
Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center