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Clinical Trials in the UK / NCT06200207
Active, not recruiting Phase 3

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

NCT06200207 · tracked via the Priya Life Science UK tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2024-04-01
Last updated
2026-09-01

Condition(s) studied

Heart FailureSystemic Inflammation

Investigational drug(s) / intervention(s)

ZiltivekimabPlacebo

Ziltivekimab: Zilitivekimab will be administered subcutaneously once-monthly.

Placebo: Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.

Study 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

Sex
ALL
Min age
18 Years
Max age
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 centimeters (cm) 3. LA length greater than or equal to 5.0 cm 4. LA area greater than or equal to 20 square centimeters (cm\^2) 5. LA volume greater than or equal to 55 milliliters (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 grams 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 centimeters 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

Primary outcome measure(s)

Trial sites (217)

FacilityCityRegionStatus
Advanced Cardiovascular, LLC Alexander City Alabama
Eastern Shore Rsrch Inst, LLC Fairhope Alabama
Cardiology & Medicine Clinic Little Rock Arkansas
Valley Clinical Trials, Inc. Northridge California
UCI Health Orange California
South California Heart Spc Pasadena California
Clearwater Cardiovascular Consultants Largo Florida
Ocala Cardiovascular Research Ocala Florida
Ormond Beach Clinical Research Ormond Beach Florida
St Johns Ctr Clin Rsch-St. Aug Saint Augustine Florida
GA Arrhythmia Cons & Rsch Inst Macon Georgia
Velocity Clin Rsrch - Savannah Savannah Georgia
Chicago Medical Research LLC Hazel Crest Illinois
UofL Health Care Outpatient Louisville Kentucky
Maryland Cardiovascular Specialists - Baltimore Baltimore Maryland
MD Medical Research Oxon Hill Maryland
Cardio and Vascular Assoc-CAVA Bloomfield Hills Michigan
Millennium Cardiology Farmington Hills Michigan
Kansas City VA Medical Center Kansas City Missouri
Washington University St Louis Missouri
Renown Regional Medical Center Reno Nevada
Long Island Cardiovascular Consultants PC Lake Success New York
Mount Sinai Hosp at NYC New York New York
Northwell Health Phys Cardio Riverhead New York
University Of North Carolina At Chapel Hill Chapel Hill North Carolina
AMS Cardiology Horsham Pennsylvania
Univ of Pennsylvania Hospital Philadelphia Pennsylvania
PharmaTex Research Amarillo Texas
University of Texas Southwestern Medical Center Dallas Texas
David Turbay, MD, PLLC El Paso Texas
Private Practice Leadership LLC. Katy Texas
Clinical Advancement Center San Antonio Texas
Clinical Advancement Ctr, PLLC San Antonio Texas
Sherman Clinical Research Sherman Texas
Northwest Heart Center Tomball Texas
Sentara Health Research Center Norfolk Virginia
Virginia Commonwealth University Richmond Virginia
Cardiología Palermo City of Buenos Aires Buenos Aires
Centro Médico CIMEL Lanús Este Buenos Aires
Instituto de Investigaciones Clinicas Quilmes SRL Buenos Aires Argentina

+ 177 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06200207 on ClinicalTrials.gov ↗ ← All trials in the UK