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ACTIVE NOT 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

673

Start Date

2024-04-01

Completion Date

2027-01-08

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

Ziltivekimab

Zilitivekimab will be administered subcutaneously once-monthly.

DRUG

Placebo

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

Locations (217)

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

UCI Health

Orange, California, United States

South California Heart Spc

Pasadena, California, 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

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

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 - Cardiology Clinical Research Centre

Chermside, Queensland, Australia

Ballarat Base Hospital

Ballarat, Victoria, Australia

Northern Private Hospital Epping - The Cardiologists

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

MHAT 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

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 für klinische Studien Südbrandenburg 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

And 117 more locations on ClinicalTrials.gov