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A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
Sponsor: Novo Nordisk A/S
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
Conditions
Interventions
Ziltivekimab
Zilitivekimab will be administered subcutaneously once-monthly.
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