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

April 4, 2026 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

680

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Novo Nordisk
Phone Number: (+1) 866-867-7178
Email: clinicaltrials@novonordisk.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1425AGC
    - Active, not recruiting
    - Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
  - Buenos Aires, Argentina, C1119ACN
    - Recruiting
    - CIPREC Pueyrredon
  - Buenos Aires, Argentina, B1878GEG
    - Active, not recruiting
    - Instituto de Investigaciones Clinicas Quilmes SRL
  - CABA, Argentina, C1061AAS
    - Completed
    - CIPREC Arenales
  - Esperanza, Santa Fe, Argentina, S3080BQV
    - Active, not recruiting
    - Sanatorio Esperanza
  - Morón, Argentina, B1708IFF
    - Active, not recruiting
    - Consultorio Integral de Atención al Diabético
  - Salta, Argentina, 4400
    - Recruiting
    - Centro Cardiovascular Salta
  - San Miguel de Tucumán, Tucumán., Argentina, T4000
    - Active, not recruiting
    - Investigaciones Clinicas Tucuman
- Buenos Aires
  - City of Buenos Aires, Buenos Aires, Argentina, C1425
    - Active, not recruiting
    - Cardiología Palermo
  - Lanús Este, Buenos Aires, Argentina, B1824KAJ
    - Recruiting
    - Centro Médico CIMEL
Australia
- Australian Capital Territory
  - Garran, Australian Capital Territory, Australia, 2605
    - Active, not recruiting
    - Canberra Hospital
- New South Wales
  - New Lambton Heights, New South Wales, Australia, 2305
    - Recruiting
    - John Hunter Hospital
  - New Lambton Heights, New South Wales, Australia, 2305
    - Active, not recruiting
    - John Hunter Hospital - Cardiovascular Department
  - Wollongong, New South Wales, Australia, 2500
    - Active, not recruiting
    - Illawarra Heart Health Centre
- Queensland
  - Brisbane, Queensland, Australia, 4032
    - Recruiting
    - The Prince Charles Hospital
  - Brisbane, Queensland, Australia, 4032
    - Active, not recruiting
    - The Prince Charles Hospital
- Victoria
  - Ballarat, Victoria, Australia, 3350
    - Not yet recruiting
    - Ballarat Base Hospital
  - Ballarat, Victoria, Australia, 3350
    - Active, not recruiting
    - Ballarat Base Hospital
  - Epping, Victoria, Australia, 3076
    - Not yet recruiting
    - The Cardiologists Pty Ltd
  - Epping, Victoria, Australia, 3076
    - Active, not recruiting
    - The Cardiologists Pty Ltd
  - Mulgrave, Victoria, Australia, 3170
    - Active, not recruiting
    - Advara HeartCare
  - Mulgrave, Victoria, Australia, 3170
    - Active, not recruiting
    - Advara HeartCare Mulgrave
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Not yet recruiting
    - Fiona Stanley Hospital Cardiology
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - Completed
    - MHAT Puls AD, Cardiology Department
  - Haskovo, Bulgaria, 6300
    - Completed
    - MHAT Haskovo AD
  - Pleven, Bulgaria, 5804
    - Active, not recruiting
    - MHAT Heart and Brain EAD - Pleven, Cardiology
  - Plovdiv, Bulgaria, 4002
    - Active, not recruiting
    - UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology
  - Sofia, Bulgaria, 1527
    - Active, not recruiting
    - Medical center ISUL - Tsaritsa Yoanna EOOD
  - Sofia, Bulgaria, 1606
    - Active, not recruiting
    - UMHATEM N.I. Pirogov EAD
  - Sofia, Bulgaria, 1784
    - Completed
    - Medical Center Synexus Sofia EOOD
  - Sofia, Bulgaria, 1750
    - Completed
    - UMHAT Sveta Anna Sofia AD, Clinic of Cardiology
  - Sofia, Bulgaria, 1510
    - Active, not recruiting
    - MC Hera EOOD - Sofia
Canada
- - Québec, Canada, G1R 2J6
    - Active, not recruiting
    - CHU de Quebec-Uni Laval-Hotel
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - Active, not recruiting
    - University of Calgary_Calgary
- Ontario
  - Cambridge, Ontario, Canada, N1R 6V6
    - Active, not recruiting
    - Cambridge Cardiac Care Centre
  - Cambridge, Ontario, Canada, N1R 7R1
    - Completed
    - Saul Vizel Pro. Med. Corp
  - Scarborough Village, Ontario, Canada, M1B 5N1
    - Completed
    - Corcare Cardiovascular Research
  - Toronto, Ontario, Canada, M6G 1M2
    - Recruiting
    - Diabetes Heart Research Centre
  - Toronto, Ontario, Canada, M6G 1M2
    - Active, not recruiting
    - Diabetes Heart Research Centre
  - Waterloo, Ontario, Canada, N2T 0C1
    - Recruiting
    - CPS Research
  - Waterloo, Ontario, Canada, N2T 0C1
    - Active, not recruiting
    - CPS Research
  - Waterloo, Ontario, Canada, N2T OC1
    - Active, not recruiting
    - Clinical Research Solutions Inc.
- Quebec
  - Montreal, Quebec, Canada, H3G 1A4
    - Active, not recruiting
    - Montreal General Hospital
  - Montreal, Quebec, Canada, H1T 1C8
    - Active, not recruiting
    - Institut de Cardiologie de Montreal
Czechia
- - Benešov, Czechia, 256 01
    - Active, not recruiting
    - Innera s.r.o.
  - Brno, Czechia, 612 00
    - Active, not recruiting
    - Kardiologicka ambulance Brno s.r.o.
  - Brno, Czechia, 61500
    - Active, not recruiting
    - Vojenska nemocnice Brno p.o.
  - Chomutov, Czechia, 430 02
    - Completed
    - Ordinace pro choroby srdce
  - Prague, Czechia, 170 00
    - Active, not recruiting
    - Medicon a.s.
  - Svitavy, Czechia, 568 25
    - Completed
    - Svitavska nemocnice Kardiologie
  - Trutnov, Czechia, 541 01
    - Completed
    - Kardiologicka ambulance MUDr. Ferkl s.r.o.
  - Třinec, Czechia, 739 61
    - Active, not recruiting
    - Nemocnice AGEL Trinec-Podlesi a.s.
France
- - Chambray-lès-Tours, France, 37170
    - Active, not recruiting
    - Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau
  - Poitiers, France, 86000
    - Completed
    - Centre Hospitalier Universitaire de Poitiers
  - Rennes, France, 35000
    - Completed
    - Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
  - Rouen, France, 76031
    - Completed
    - Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
  - Toulon, France, 83100
    - Active, not recruiting
    - Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
  - Valenciennes, France, 59300
    - Completed
    - Polyclinique Vauban
  - Vandœuvre-lès-Nancy, France, 54500
    - Active, not recruiting
    - Chru de Nancy - Hopital Brabois
Germany
- - Bremen, Germany, 28277
    - Completed
    - Kardiologisch-Angiologische Praxis Herzzentrum Bremen
  - Dresden, Germany, 01307
    - Active, not recruiting
    - Uniklinik TU Dresden - Herzzentrum Dresden GmbH
  - Elsterwerda, Germany, 04910
    - Active, not recruiting
    - Zentrum fuer Klinische Studien Suedbrandenburg GmbH
  - Erfurt, Germany, 99097
    - Completed
    - Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II
  - Frankfurt, Germany, 60389
    - Completed
    - MVZ CCB Frankfurt und Main-Taunus GbR
  - Freiburg im Breisgau, Germany, 79106
    - Active, not recruiting
    - Universitätsklinikum Freiburg - Medical Center
  - Fulda, Germany, 36037
    - Active, not recruiting
    - MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
  - Homburg, Germany, 66421
    - Active, not recruiting
    - Universität des Saarlandes - Innere Med. III
  - Kaiserslautern, Germany, 67655
    - Completed
    - Kardiopraxis Schirmer
  - Mainz, Germany, 55116
    - Completed
    - Gesundheitscentrum Mainz (Regner / Schmitt)
Greece
- - Athens, Greece, 11527
    - Not yet recruiting
    - 'G. Gennimatas' General Hospital of Athens
  - Athens, Greece, GR-11521
    - Not yet recruiting
    - Naval Hospital of Athens
  - Athens, Greece, 10676
    - Active, not recruiting
    - Evangelismos Hospital
  - Athens, Greece, 11527
    - Active, not recruiting
    - "Laiko" General Hospital of Athens
  - Athens, Greece, 14233
    - Active, not recruiting
    - Konstantopouleio G.H. of Athens, "Agia Olga"
  - Athens, Greece, 15123
    - Active, not recruiting
    - "Hygeia" General Hospital of Athens
  - Athens, Greece, 15562
    - Active, not recruiting
    - Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic
  - Athens, Greece, 11527
    - Active, not recruiting
    - 'G. Gennimatas' General Hospital of Athens - Cardiology Department
  - Athens, Greece, 11521
    - Active, not recruiting
    - Naval Hospital of Athens - Clinic of Cardiology
  - Chaidari, Athens, Greece, GR-12462
    - Not yet recruiting
    - U.G.H of Athens "Attikon"
  - Chaidari, Athens, Greece, 12462
    - Active, not recruiting
    - U.G.H of Athens "Attikon"
  - Chalcis, Greece, 34100
    - Completed
    - General Hospital of Kalamata - Cardiology Department
  - Chios, Greece, 82100
    - Active, not recruiting
    - General Hospital of Chios "Skilitsio" - Cardiology Clinic
  - Larissa, Greece, 41110
    - Active, not recruiting
    - Univ Gen Hospital Larisa, Cardiology Medicine Clinic
  - Marousi, Greece, 151 26
    - Active, not recruiting
    - Sismanogleio General Hospital - Cardiology Department
  - Thessaloniki, Greece, 54636
    - Active, not recruiting
    - "AHEPA" University General Hospital of Thessaloniki
  - Thessaloniki, Greece, 54642
    - Completed
    - 'Ippokrateio' General Hospital of Thessaloniki
  - Thessaloniki, Greece, 57010
    - Completed
    - Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt
- Attica
  - Athens, Attica, Greece, 11528
    - Active, not recruiting
    - Alexandra General Hospital, Therapeutic Clinic
India
- Andhra Pradesh
  - Vijayawada, Andhra Pradesh, India, 520008
    - Active, not recruiting
    - Government Siddhartha Medical College & Government General Hospital, Vijayawada
  - Visakhapatnam, Andhra Pradesh, India, 530002
    - Completed
    - King George Hospital
- Gujarat
  - Vadodara, Gujarat, India, 390022
    - Active, not recruiting
    - Rhythm Heart Institute
- Karnataka
  - Belagavi, Karnataka, India, 590010
    - Not yet recruiting
    - KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
  - Belagavi, Karnataka, India, 590010
    - Completed
    - KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
  - Bengaluru, Karnataka, India, 560069
    - Not yet recruiting
    - Sri Jayadeva Institute of Cardiovascular Sciences & Research
  - Bengaluru, Karnataka, India, 560034
    - Recruiting
    - St John's Medical College Hospital
  - Bengaluru, Karnataka, India, 560034
    - Completed
    - St John's Medical College Hospital
  - Bengaluru, Karnataka, India, 560069
    - Completed
    - Sri Jayadeva Institute of Cardiovascular Sciences & Research
  - Mysuru, Karnataka, India, 570015
    - Completed
    - Manipal Hospital, Mysuru
  - Udupi, Karnataka, India, 576104
    - Not yet recruiting
    - Kasturba Medical College and Hospital, Manipal
  - Udupi, Karnataka, India, 576104
    - Completed
    - Kasturba Medical College and Hospital, Manipal
- Maharashtra
  - Nagpur, Maharashtra, India, 440033
    - Recruiting
    - Sengupta Hospital and Research Institute
  - Nagpur, Maharashtra, India, 440033
    - Active, not recruiting
    - Sengupta Hospital and Research Institute
  - Nagpur, Maharashtra, India, 441108
    - Active, not recruiting
    - All India Institute of Medical Sciences (AIIMS), Nagpur
  - Nashik, Maharashtra, India, 422005
    - Not yet recruiting
    - Vijan Hospital & Research Centre
  - Nashik, Maharashtra, India, 422005
    - Not yet recruiting
    - Chopda Medicare and Research Centre Pvt. Ltd.
  - Nashik, Maharashtra, India, 422005
    - Completed
    - Chopda Medicare and Research Centre Pvt. Ltd.
  - Nashik, Maharashtra, India, 422005
    - Active, not recruiting
    - Vijan Hospital & Research Centre
  - Pune, Maharashtra, India, 411028
    - Active, not recruiting
    - Villoo Poonawalla Memorial Hospital
- National Capital Territory of Delhi
  - New Delhi, National Capital Territory of Delhi, India, 110002
    - Not yet recruiting
    - G B Pant Institute of Postgraduate Medical Education and Research
  - New Delhi, National Capital Territory of Delhi, India, 110029
    - Completed
    - All India Institute Of Medical Sciences (AIIMS)
  - New Delhi, National Capital Territory of Delhi, India, 110029
    - Completed
    - Vardhaman Mahavir Medical College & Safdarjung Hospital
  - New Delhi, National Capital Territory of Delhi, India, 110093
    - Completed
    - Rajiv Gandhi Super Speciality Hospital
  - New Delhi, National Capital Territory of Delhi, India, 110060
    - Active, not recruiting
    - Sir Ganga Ram Hospital
  - New Delhi, National Capital Territory of Delhi, India, 110002
    - Active, not recruiting
    - G B Pant Institute of Postgraduate Medical Education and Research
- Odisha
  - Bhubaneswar, Odisha, India, 751019
    - Recruiting
    - All India Institute of Medical Sciences (AIIMS), Bhubaneswar
  - Bhubaneswar, Odisha, India, 751019
    - Active, not recruiting
    - All India Institute of Medical Sciences (AIIMS), Bhubaneswar
- Rajasthan
  - Bikaner, Rajasthan, India, 334003
    - Completed
    - S.P. Medical College & Associated Group of Hospitals
- Tamil Nadu
  - Puducherry, Tamil Nadu, India, 605006
    - Completed
    - Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
- Telangana
  - Hyderabad, Telangana, India, 500020
    - Active, not recruiting
    - Guru Nanak CARE Hospitals
  - Hyderabad, Telangana, India, 500055
    - Active, not recruiting
    - Malla Reddy Narayana Multispeciality Hospital
- Uttar Pradesh
  - Aligarh, Uttar Pradesh, India, 202002
    - Active, not recruiting
    - Jawaharlal Nehru Medical College and Hospital
  - Kanpur, Uttar Pradesh, India, 208002
    - Not yet recruiting
    - Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
  - Kanpur, Uttar Pradesh, India, 208002
    - Active, not recruiting
    - Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
  - Lucknow, Uttar Pradesh, India, 226010
    - Completed
    - Dr. Ram Manohar Lohia Institute of Medical Sciences
  - Lucknow, Uttar Pradesh, India, 226014
    - Active, not recruiting
    - Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Utter Pradesh
  - Aligarh, Utter Pradesh, India, 202002
    - Not yet recruiting
    - Jawaharlal Nehru Medical College and Hospital
- West Bengal
  - Kolkata, West Bengal, India, 700027
    - Not yet recruiting
    - B M Birla Heart Research Centre
  - Kolkata, West Bengal, India, 700027
    - Completed
    - B M Birla Heart Research Centre
Malaysia
- - Kota Bharu, Kelantan, Malaysia, 15586
    - Recruiting
    - Hospital Raja Perempuan Zainab II
- Johor
  - Johor Bahru, Johor, Malaysia, 80100
    - Recruiting
    - Hospital Sultanah Aminah
  - Johor Bahru, Johor, Malaysia, 80100
    - Active, not recruiting
    - Hospital Sultanah Aminah
- Kedah
  - Alor Star, Kedah, Malaysia, 05460
    - Active, not recruiting
    - Hospital Sultanah Bahiyah
- Kelantan
  - Kota Bharu, Kelantan, Malaysia, 15586
    - Active, not recruiting
    - Hospital Raja Perempuan Zainab II
- Kuala Lumpur
  - Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - University Malaya Medical Centre
  - Lembah Pantai, Kuala Lumpur, Malaysia, 59100
    - Active, not recruiting
    - University Malaya Medical Centre
- Pahang
  - Kuantan, Pahang, Malaysia, 25100
    - Active, not recruiting
    - Hospital Tengku Ampuan Afzan
- Perak
  - Ipoh, Perak, Malaysia, 30450
    - Completed
    - Hospital Raja Permaisuri Bainun Ipoh
- Selangor
  - Kajang, Selangor, Malaysia, 43000
    - Active, not recruiting
    - Hospital Serdang
Poland
- - Bielsko-Biala, Poland, 43-316
    - Active, not recruiting
    - American Heart of Poland S.A.
  - Bydgoszcz, Poland, 85-681
    - Completed
    - 10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy
  - Gdynia, Poland, 81-348
    - Not yet recruiting
    - Szpitale Pomorskie Sp. z o.o.
  - Lublin, Poland, 20-601
    - Completed
    - Zanamed Medical Clinic Sp. z o.o.
  - Piotrkow Trybunalski, Poland, 97-300
    - Recruiting
    - Trialmed Sp. z o. o.
  - Piotrkow Trybunalski, Poland, 97-300
    - Active, not recruiting
    - Trialmed Sp. z o. o.
  - Poznan, Poland, 61-848
    - Not yet recruiting
    - Uniwersytecki Szpital Kliniczny w Poznaniu
  - Poznan, Poland, 61-848
    - Completed
    - Uniwersytecki Szpital Kliniczny w Poznaniu
  - Tychy, Poland, 43-100
    - Completed
    - American Heart of Poland S.A.
  - Warsaw, Poland, 02-507
    - Completed
    - Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
- Kuyavian-Pomeranian Voivodeship
  - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-605
    - Active, not recruiting
    - Centrum Medyczne Intercor Sp. z o.o.
  - Włocławek, Kuyavian-Pomeranian Voivodeship, Poland, 87-800
    - Not yet recruiting
    - Kardio Life
  - Włocławek, Kuyavian-Pomeranian Voivodeship, Poland, 87-800
    - Active, not recruiting
    - Kardio Life - Tomasz Borkowski
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-002
    - Not yet recruiting
    - Cardiomedicum Sp. z o.o.
  - Krakow, Lesser Poland Voivodeship, Poland, 30-002
    - Active, not recruiting
    - Cardiomedicum Sp. z o.o.
  - Krakow, Lesser Poland Voivodeship, Poland, 30-721
    - Completed
    - Linden sp. z o.o. sp. k.
  - Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
    - Active, not recruiting
    - Formed 2 Sp. z o.o.
- Lower Silesian Voivodeship
  - Jelenia Góra, Lower Silesian Voivodeship, Poland, 58-506
    - Completed
    - Pratia S.A.
  - Wroclaw, Lower Silesian Voivodeship, Poland, 50-981
    - Active, not recruiting
    - 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
- Lublin Voivodeship
  - Puławy, Lublin Voivodeship, Poland, 24-100
    - Active, not recruiting
    - Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
- Masovian Voivodeship
  - Żyrardów, Masovian Voivodeship, Poland, 96-300
    - Active, not recruiting
    - Prywatna Praktyka Lekarska Anna Chudoba
- Podlaskie Voivodeship
  - Bialystok, Podlaskie Voivodeship, Poland, 15-540
    - Not yet recruiting
    - Uniwersytecki Szpital Kliniczny W Bialymstoku
  - Bialystok, Podlaskie Voivodeship, Poland, 15-540
    - Completed
    - Uniwersytecki Szpital Kliniczny W Bialymstoku
- Pomeranian Voivodeship
  - Gdynia, Pomeranian Voivodeship, Poland, 81-157
    - Active, not recruiting
    - Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
  - Gdynia, Pomeranian Voivodeship, Poland, 81-348
    - Completed
    - Szpitale Pomorskie Sp. z o.o.
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Poland, 93-513
    - Active, not recruiting
    - Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
  - Lodz, Łódź Voivodeship, Poland, 90-549
    - Active, not recruiting
    - Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi
Portugal
- - Guilhufe - Penafiel, Portugal, 4560-136
    - Not yet recruiting
    - CHTâmega e Sousa - Hospital Padre Américo
  - Lisbon, Portugal, 1449-005
    - Not yet recruiting
    - CHLO, EPE - Hospital São Francisco Xavier
  - Lisbon, Portugal, 1500-650
    - Not yet recruiting
    - Hospital da Luz
  - Lisbon, Portugal, 1649-035
    - Not yet recruiting
    - Centro Hospitalar Lisboa Norte
  - Setúbal, Portugal, 2910-446
    - Not yet recruiting
    - Centro Hospitalar de Setubal
Spain
- - Madrid, Spain, 28034
    - Active, not recruiting
    - Hospital Ramon y Cajal
  - Madrid, Spain, 28007
    - Active, not recruiting
    - Hospital Gregorio Marañon
  - Sanlúcar de Barrameda, Spain, 11540
    - Active, not recruiting
    - H Virgen del Camino_Sanlúcar_Medicina Interna
  - Santiago de Compostela, Spain, 15706
    - Active, not recruiting
    - Complejo Hospitalario Universitario de Santiago
  - Seville, Spain, 41003
    - Completed
    - Clínica Nuevas Tecnologías en Diabetes y Endocrinología
  - Valencia, Spain, 46010
    - Active, not recruiting
    - Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA)
- Andalusia
  - Castilleja de la Cuesta, Andalusia, Spain, 41950
    - Active, not recruiting
    - Hospital Vithas Sevilla
- Castille and León
  - Salamanca, Castille and León, Spain, 37007
    - Not yet recruiting
    - Hospital Universitario de Salamanca
  - Salamanca, Castille and León, Spain, 37007
    - Completed
    - Hospital Universitario de Salamanca
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Active, not recruiting
    - Hospital Universitario Puerta de Hierro Majadahonda
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01000
    - Not yet recruiting
    - T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
  - Adana, Turkey (Türkiye), 01060
    - Active, not recruiting
    - Adana Şehir Eğitim ve Araştırma Hastanesi
  - Afyonkarahisar, Turkey (Türkiye), 03200
    - Not yet recruiting
    - Afyonkarahisar Health Sciences University
  - Afyonkarahisar, Turkey (Türkiye), 03200
    - Active, not recruiting
    - Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji
  - Ankara, Turkey (Türkiye), 06800
    - Not yet recruiting
    - Ankara Sehir Hastanesi Cardiology
  - Ankara, Turkey (Türkiye), 06800
    - Active, not recruiting
    - Ankara Bilkent Şehir Hastanesi-Kardiyoloji
  - Bursa, Turkey (Türkiye), 16110
    - Active, not recruiting
    - Bursa Şehir Hastanesi- Kardiyoloji
  - Edirne, Turkey (Türkiye), 22030
    - Not yet recruiting
    - Trakya University
  - Edirne, Turkey (Türkiye), 22030
    - Active, not recruiting
    - Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji
  - Istanbul, Turkey (Türkiye), 34480
    - Active, not recruiting
    - Başakşehir Çam ve Sakura Şehir Hastanesi
  - Kayseri, Turkey (Türkiye), 38039
    - Not yet recruiting
    - Erciyes University Cardiology
  - Kayseri, Turkey (Türkiye), 38039
    - Recruiting
    - Erciyes Üniversitesi Hastanesi- Kardiyoloji
  - Kocaeli, Turkey (Türkiye), 41380
    - Active, not recruiting
    - Kocaeli Üniversitesi Hastanesi- Kardiyoloji
- Odunpazari
  - Eskişehir, Odunpazari, Turkey (Türkiye), 26040
    - Active, not recruiting
    - Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji
United Kingdom
- - Birmingham, United Kingdom, B21 9RY
    - Active, not recruiting
    - FutureMeds
  - Dundee, United Kingdom, DD1 9SY
    - Completed
    - Ninewells Hospital
  - Peterborough, United Kingdom, PE3 9GZ
    - Completed
    - Peterborough City Hospital
- Highland
  - Inverness, Highland, United Kingdom, IV2 3JH
    - Completed
    - Raigmore Hospital
- West Sussex
  - Chichester, West Sussex, United Kingdom, PO19 6SE
    - Active, not recruiting
    - St. Richard's Hospital_Cardiology
United States
- Alabama
  - Alexander City, Alabama, United States, 35010
    - Completed
    - Advanced Cardiovascular, LLC
  - Fairhope, Alabama, United States, 36532
    - Active, not recruiting
    - Eastern Shore Rsrch Inst, LLC
- Arkansas
  - Little Rock, Arkansas, United States, 72204
    - Completed
    - Cardiology & Medicine Clinic
- California
  - Northridge, California, United States, 91325
    - Recruiting
    - Valley Clinical Trials, Inc.
  - Northridge, California, United States, 91325
    - Active, not recruiting
    - Valley Clinical Trials, Inc.
  - Orange, California, United States, 92868
    - Completed
    - UCI Health
  - Pasadena, California, United States, 91105
    - Active, not recruiting
    - South California Heart Spc
- Florida
  - Largo, Florida, United States, 33777
    - Recruiting
    - Clearwater Cardiovascular Consultants
  - Largo, Florida, United States, 33777
    - Completed
    - Clearwater Cardiovascular Consultants
  - Ocala, Florida, United States, 34471
    - Active, not recruiting
    - Ocala Cardiovascular Research
  - Ormond Beach, Florida, United States, 32174
    - Active, not recruiting
    - Ormond Beach Clinical Research
  - Saint Augustine, Florida, United States, 32086
    - Active, not recruiting
    - St Johns Ctr Clin Rsch-St. Aug
- Georgia
  - Macon, Georgia, United States, 31201
    - Active, not recruiting
    - GA Arrhythmia Cons & Rsch Inst
  - Savannah, Georgia, United States, 31406
    - Completed
    - Velocity Clin Rsrch - Savannah
- Illinois
  - Hazel Crest, Illinois, United States, 60429
    - Completed
    - Chicago Medical Research LLC
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Active, not recruiting
    - UofL Health Care Outpatient
- Maryland
  - Baltimore, Maryland, United States, 21229
    - Completed
    - Maryland Cardiovascular Specialists - Baltimore
  - Oxon Hill, Maryland, United States, 20745
    - Completed
    - MD Medical Research
- Michigan
  - Bloomfield Hills, Michigan, United States, 48304
    - Active, not recruiting
    - Cardio and Vascular Assoc-CAVA
  - Farmington Hills, Michigan, United States, 48334
    - Active, not recruiting
    - Millennium Cardiology
- Missouri
  - Kansas City, Missouri, United States, 64128
    - Recruiting
    - Kansas City VA Medical Center
  - Kansas City, Missouri, United States, 64128
    - Completed
    - Kansas City VA Medical Center
  - St Louis, Missouri, United States, 63110
    - Active, not recruiting
    - Washington University
- Nevada
  - Reno, Nevada, United States, 89502
    - Active, not recruiting
    - Renown Regional Medical Center
- New York
  - Lake Success, New York, United States, 11042
    - Completed
    - Long Island Cardiovascular Consultants PC
  - New York, New York, United States, 10019
    - Active, not recruiting
    - Mount Sinai Hosp at NYC
  - Riverhead, New York, United States, 11901
    - Active, not recruiting
    - Northwell Health Phys Cardio
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7046
    - Active, not recruiting
    - University of North Carolina at Chapel Hill
- Pennsylvania
  - Horsham, Pennsylvania, United States, 19044
    - Active, not recruiting
    - AMS Cardiology
  - Philadelphia, Pennsylvania, United States, 19104
    - Active, not recruiting
    - Univ of Pennsylvania Hospital
- Texas
  - Amarillo, Texas, United States, 79106
    - Recruiting
    - Pharmatex Research
  - Amarillo, Texas, United States, 79106
    - Active, not recruiting
    - Pharmatex Research
  - Dallas, Texas, United States, 75390-9302
    - Active, not recruiting
    - University of Texas Southwestern Medical Center
  - El Paso, Texas, United States, 79905
    - Active, not recruiting
    - David Turbay, MD, PLLC
  - Katy, Texas, United States, 77493
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    - Private Practice Leadership LLC.
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    - Not yet recruiting
    - Clinical Advancement Ctr, PLLC
  - San Antonio, Texas, United States, 78212
    - Active, not recruiting
    - Clinical Advancement Center
  - Sherman, Texas, United States, 75090
    - Active, not recruiting
    - Sherman Clinical Research
  - Tomball, Texas, United States, 77375
    - Active, not recruiting
    - Northwest Heart Center
- Virginia
  - Norfolk, Virginia, United States, 23507
    - Completed
    - Sentara Health Research Center
  - Richmond, Virginia, United States, 23219
    - Completed
    - Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	Measured as score (score on scale; range; 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.	From randomisation (month 0) to end-of-treatment (month 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.	From randomisation (month 0) to end-of-treatment (month 12)
Participant achieving threshold for clinically meaningful within-participant change in 6-minute walk distance (6MWD) (yes/no) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	Measured as count of participants.	From randomisation (month 0) to end-of-treatment (month 12)
Participants improving 5 points or more in KCCQ-CSS (yes/no) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.	From randomisation (month 0) to end-of-treatment (month 12)
Participants improving 10 points or more in KCCQ-CSS (yes/no) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.	From randomisation (month 0) to end-of-treatment (month 12)
Change in subscales of KCCQ (total symptom score, physical limitations score, social limitations score, and health-related quality of life) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	Measured as score (score on scale; range 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.	From randomisation (month 0) to end-of-treatment (month 12)
Change in six-minute walk distance (6MWD) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	Measured in meters.	From randomisation (month 0) to end-of-treatment (month 12)
Change in high-sensitivity C-reactive protein (hs-CRP) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	Measured as ratio to baseline.	From randomisation (month 0) to end-of-treatment (month 12)
Participants experiencing improvement in New York heart association (NYHA) Class (yes/no) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	Measured as count of participants. The New York Heart Association (NYHA) classification provides a simple way of classifying the extent of heart failure (HF). It classifies patients in one of four categories based on their limitations during physical activity - Class I: Participant with cardiac disease but without resulting limitations of physical activity, Class II: Participants with cardiac disease resulting in slight limitation of physical activity, Class III: Participants with cardiac disease resulting in marked limitation of physical activity, Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort.	From randomisation (month 0) to end-of-treatment (month 12)
Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	Measured as ratio to baseline.	From randomisation (month 0) to end-of-treatment (month 12)
Change in eGFR (CKD-EPI) Time Frame: From randomisation (month 0) to end-of-treatment (month 12)	eGFR (CKD-EPI) is estimated glomerular filtration rate chronic kidney disease - epidemiology collaboration. Measured in milliliter per minute per 1.73 square meter (ml/min/1.73^2).	From randomisation (month 0) to end-of-treatment (month 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 8, 2027

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NN6018-4914
U1111-1293-7516 (Other Identifier: World Health Organisation (WHO))
2023-506988-34 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Heart Failure

Clinical Trials on Ziltivekimab

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