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RECRUITING

NCT06200207

PHASE3

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

680

Start Date

2024-04-01

Completion Date

2027-01-08

Last Updated

2026-04-07

Healthy Volunteers

Conditions

Heart Failure Systemic Inflammation

Interventions

DRUG

Ziltivekimab

Zilitivekimab will be administered subcutaneously once-monthly.

DRUG

Placebo

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

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

Locations (240)

Advanced Cardiovascular, LLC

Alexander City, Alabama, United States

Eastern Shore Rsrch Inst, LLC

Fairhope, Alabama, United States

Cardiology & Medicine Clinic

Little Rock, Arkansas, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

UCI Health

Orange, California, United States

South California Heart Spc

Pasadena, California, United States

Clearwater Cardiovascular Consultants

Largo, Florida, United States

Clearwater Cardiovascular Consultants

Largo, Florida, United States

Ocala Cardiovascular Research

Ocala, Florida, United States

Ormond Beach Clinical Research

Ormond Beach, Florida, United States

St Johns Ctr Clin Rsch-St. Aug

Saint Augustine, Florida, United States

GA Arrhythmia Cons & Rsch Inst

Macon, Georgia, United States

Velocity Clin Rsrch - Savannah

Savannah, Georgia, United States

Chicago Medical Research LLC

Hazel Crest, Illinois, United States

UofL Health Care Outpatient

Louisville, Kentucky, United States

Maryland Cardiovascular Specialists - Baltimore

Baltimore, Maryland, United States

MD Medical Research

Oxon Hill, Maryland, United States

Cardio and Vascular Assoc-CAVA

Bloomfield Hills, Michigan, United States

Millennium Cardiology

Farmington Hills, Michigan, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

Washington University

St Louis, Missouri, United States

Renown Regional Medical Center

Reno, Nevada, United States

Long Island Cardiovascular Consultants PC

Lake Success, New York, United States

Mount Sinai Hosp at NYC

New York, New York, United States

Northwell Health Phys Cardio

Riverhead, New York, United States

University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

AMS Cardiology

Horsham, Pennsylvania, United States

Univ of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

PharmaTex Research

Amarillo, Texas, United States

PharmaTex Research

Amarillo, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

David Turbay, MD, PLLC

El Paso, Texas, United States

Private Practice Leadership LLC.

Katy, Texas, United States

Clinical Advancement Center

San Antonio, Texas, United States

Clinical Advancement Ctr, PLLC

San Antonio, Texas, United States

Sherman Clinical Research

Sherman, Texas, United States

Northwest Heart Center

Tomball, Texas, United States

Sentara Health Research Center

Norfolk, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Cardiología Palermo

City of Buenos Aires, Buenos Aires, Argentina

Centro Médico CIMEL

Lanús Este, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes SRL

Buenos Aires, Argentina

CIPREC Pueyrredon

Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

Buenos Aires, Argentina

CIPREC Arenales

CABA, Argentina

Sanatorio Esperanza

Esperanza, Santa Fe, Argentina

Consultorio Integral de Atención al Diabético

Morón, Argentina

Centro Cardiovascular Salta

Salta, Argentina

Investigaciones Clinicas Tucuman

San Miguel de Tucumán, Tucumán., Argentina

Canberra Hospital

Garran, Australian Capital Territory, Australia

John Hunter Hospital - Cardiovascular Department

New Lambton Heights, New South Wales, Australia

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Illawarra Heart Health Centre

Wollongong, New South Wales, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

Ballarat Base Hospital

Ballarat, Victoria, Australia

Ballarat Base Hospital

Ballarat, Victoria, Australia

The Cardiologists Pty Ltd

Epping, Victoria, Australia

The Cardiologists Pty Ltd

Epping, Victoria, Australia

Advara HeartCare Mulgrave

Mulgrave, Victoria, Australia

Advara HeartCare

Mulgrave, Victoria, Australia

Fiona Stanley Hospital Cardiology

Murdoch, Western Australia, Australia

MHAT Puls AD, Cardiology Department

Blagoevgrad, Bulgaria

MHAT Haskovo AD

Haskovo, Bulgaria

MHAT Heart and Brain EAD - Pleven, Cardiology

Pleven, Bulgaria

UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology

Plovdiv, Bulgaria

MC Hera EOOD - Sofia

Sofia, Bulgaria

Medical center ISUL - Tsaritsa Yoanna EOOD

Sofia, Bulgaria

UMHATEM N.I. Pirogov EAD

Sofia, Bulgaria

UMHAT Sveta Anna Sofia AD, Clinic of Cardiology

Sofia, Bulgaria

Medical Center Synexus Sofia EOOD

Sofia, Bulgaria

University of Calgary_Calgary

Calgary, Alberta, Canada

Cambridge Cardiac Care Centre

Cambridge, Ontario, Canada

Saul Vizel Pro. Med. Corp

Cambridge, Ontario, Canada

Corcare Cardiovascular Research

Scarborough Village, Ontario, Canada

Diabetes Heart Research Centre

Toronto, Ontario, Canada

Diabetes Heart Research Centre

Toronto, Ontario, Canada

CPS Research

Waterloo, Ontario, Canada

CPS Research

Waterloo, Ontario, Canada

Clinical Research Solutions Inc.

Waterloo, Ontario, Canada

Institut de Cardiologie de Montreal

Montreal, Quebec, Canada

Montreal General Hospital

Montreal, Quebec, Canada

CHU de Quebec-Uni Laval-Hotel

Québec, Canada

Innera s.r.o.

Benešov, Czechia

Kardiologicka ambulance Brno s.r.o.

Brno, Czechia

Vojenská nemocnice Brno p.o.

Brno, Czechia

Ordinace pro choroby srdce

Chomutov, Czechia

MEDICON a.s.

Prague, Czechia

Svitavska nemocnice Kardiologie

Svitavy, Czechia

Kardiologická ambulance MUDr. Ferkl s.r.o.

Trutnov, Czechia

Nemocnice AGEL Třinec-Podlesí a.s.

Třinec, Czechia

Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau

Chambray-lès-Tours, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, France

Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

Rouen, France

Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse

Toulon, France

Polyclinique Vauban

Valenciennes, France

Chru de Nancy - Hopital Brabois

Vandœuvre-lès-Nancy, France

Kardiologisch-Angiologische Praxis Herzzentrum Bremen

Bremen, Germany

Uniklinik TU Dresden - Herzzentrum Dresden GmbH

Dresden, Germany

Zentrum fuer klinische Studien Suedbrandenburg GmbH

Elsterwerda, Germany

Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II

Erfurt, Germany

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt, Germany

Universitätsklinikum Freiburg - Medical Center

Freiburg im Breisgau, Germany

MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien

Fulda, Germany

Universität des Saarlandes - Innere Med. III

Homburg, Germany

Kardiopraxis Schirmer

Kaiserslautern, Germany

Gesundheitscentrum Mainz (Regner / Schmitt)

Mainz, Germany

Alexandra General Hospital, Therapeutic Clinic

Athens, Attica, Greece

Evangelismos Hospital

Athens, Greece

Naval Hospital of Athens - Clinic of Cardiology

Athens, Greece

"Laiko" General Hospital of Athens

Athens, Greece

'G. Gennimatas' General Hospital of Athens - Cardiology Department

Athens, Greece

'G. Gennimatas' General Hospital of Athens

Athens, Greece

Konstantopouleio G.H. of Athens, "Agia Olga"

Athens, Greece

"Hygeia" General Hospital of Athens

Athens, Greece

Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic

Athens, Greece

Naval Hospital of Athens

Athens, Greece

U.G.H of Athens "Attikon"

Chaidari, Athens, Greece

U.G.H of Athens "Attikon"

Chaidari, Athens, Greece

General Hospital of Kalamata - Cardiology Department

Chalcis, Greece

General Hospital of Chios "Skilitsio" - Cardiology Clinic

Chios, Greece

Univ Gen Hospital Larisa, Cardiology Medicine Clinic

Larissa, Greece

Sismanogleio General Hospital - Cardiology Department

Marousi, Greece

"AHEPA" University General Hospital of Thessaloniki

Thessaloniki, Greece

'Ippokrateio' General Hospital of Thessaloniki

Thessaloniki, Greece

Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt

Thessaloniki, Greece

Government Siddhartha Medical College & Government General Hospital, Vijayawada

Vijayawada, Andhra Pradesh, India

King George Hospital

Visakhapatnam, Andhra Pradesh, India

Rhythm Heart Institute

Vadodara, Gujarat, India

KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre

Belagavi, Karnataka, India

KLES Dr. Prabhakar Kore Hospital & Medical Research Centre

Belagavi, Karnataka, India

St John's Medical College Hospital

Bengaluru, Karnataka, India

St John's Medical College Hospital

Bengaluru, Karnataka, India

Sri Jayadeva Institute of Cardiovascular Sciences & Research

Bengaluru, Karnataka, India

Sri Jayadeva Institute of Cardiovascular Sciences & Research

Bengaluru, Karnataka, India

Manipal Hospital, Mysuru

Mysuru, Karnataka, India

Kasturba Medical College and Hospital, Manipal

Udupi, Karnataka, India

Kasturba Medical College and Hospital, Manipal

Udupi, Karnataka, India

Sengupta Hospital and Research Institute

Nagpur, Maharashtra, India

Sengupta Hospital and Research Institute

Nagpur, Maharashtra, India

All India Institute of Medical Sciences (AIIMS), Nagpur

Nagpur, Maharashtra, India

Chopda Medicare and Research Centre Pvt. Ltd.

Nashik, Maharashtra, India

Chopda Medicare and Research Centre Pvt. Ltd.

Nashik, Maharashtra, India

Vijan Hospital & Research Centre

Nashik, Maharashtra, India

Vijan Hospital & Research Centre

Nashik, Maharashtra, India

Villoo Poonawalla Memorial Hospital

Pune, Maharashtra, India

G B Pant Institute of Postgraduate Medical Education and Research