A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
ATHENA
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
3 other identifiers
interventional
680
16 countries
239
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 heart-failure
Started Apr 2024
239 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2023
CompletedFirst Posted
Study publicly available on registry
January 10, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 8, 2027
March 11, 2026
March 1, 2026
2.5 years
December 28, 2023
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
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 Outcomes (10)
Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
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)
From randomisation (month 0) to end-of-treatment (month 12)
Participants improving 5 points or more in KCCQ-CSS (yes/no)
From randomisation (month 0) to end-of-treatment (month 12)
Participants improving 10 points or more in KCCQ-CSS (yes/no)
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)
From randomisation (month 0) to end-of-treatment (month 12)
- +5 more secondary outcomes
Study Arms (2)
Ziltivekimab
ACTIVE COMPARATORParticipants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m\^2)
- LA diameter greater than or equal to 3.8 centimeter (cm)
- LA length greater than or equal to 5.0 cm
- LA area greater than or equal to 20 square centimeter (cm\^2)
- LA volume greater than or equal to 55 milliliter (mL)
- Intraventricular septal thickness greater than or equal to 1.1 cm
- Posterior wall thickness greater than or equal to 1.1 cm
- 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)
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (239)
Advanced Cardiovascular, LLC
Alexander City, Alabama, 35010, United States
Eastern Shore Rsrch Inst, LLC
Fairhope, Alabama, 36532, United States
Cardiology & Medicine Clinic
Little Rock, Arkansas, 72204, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
UCI Health
Orange, California, 92868, United States
South California Heart Spc
Pasadena, California, 91105, United States
Clearwater Cardiovascular Consultants
Largo, Florida, 33777, United States
Clearwater Cardiovascular Consultants
Largo, Florida, 33777, United States
Ocala Cardiovascular Research
Ocala, Florida, 34471, United States
Ormond Beach Clinical Research
Ormond Beach, Florida, 32174, United States
St Johns Ctr Clin Rsch-St. Aug
Saint Augustine, Florida, 32086, United States
GA Arrhythmia Cons & Rsch Inst
Macon, Georgia, 31201, United States
Velocity Clin Rsrch - Savannah
Savannah, Georgia, 31406, United States
Chicago Medical Research LLC
Hazel Crest, Illinois, 60429, United States
UofL Health Care Outpatient
Louisville, Kentucky, 40202, United States
Maryland Cardiovascular Specialists - Baltimore
Baltimore, Maryland, 21229, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
Cardio and Vascular Assoc-CAVA
Bloomfield Hills, Michigan, 48304, United States
Millennium Cardiology
Farmington Hills, Michigan, 48334, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Washington University
St Louis, Missouri, 63110, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Long Island Cardiovascular Consultants PC
Lake Success, New York, 11042, United States
Mount Sinai Hosp at NYC
New York, New York, 10019, United States
Northwell Health Phys Cardio
Riverhead, New York, 11901, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599-7046, United States
AMS Cardiology
Horsham, Pennsylvania, 19044, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
PharmaTex Research
Amarillo, Texas, 79106, United States
PharmaTex Research
Amarillo, Texas, 79106, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9302, United States
David Turbay, MD, PLLC
El Paso, Texas, 79905, United States
Private Practice Leadership LLC.
Katy, Texas, 77493, United States
Clinical Advancement Center
San Antonio, Texas, 78212, United States
Clinical Advancement Ctr, PLLC
San Antonio, Texas, 78212, United States
Sherman Clinical Research
Sherman, Texas, 75090, United States
Northwest Heart Center
Tomball, Texas, 77375, United States
Sentara Health Research Center
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Cardiología Palermo
City of Buenos Aires, Buenos Aires, C1425, Argentina
Centro Médico CIMEL
Lanús Este, Buenos Aires, B1824KAJ, Argentina
Instituto de Investigaciones Clinicas Quilmes SRL
Buenos Aires, B1878GEG, Argentina
CIPREC Pueyrredon
Buenos Aires, C1119ACN, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires, C1425AGC, Argentina
Centro de Investigación y Prevención Cardiovascular
CABA, C1061AAS, Argentina
Sanatorio Esperanza
Esperanza, Santa Fe, S3080BQV, Argentina
Consultorio Integral de Atención al Diabético
Morón, B1708IFF, Argentina
Centro Cardiovascular Salta
Salta, 4400, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán, Tucumán., T4000, Argentina
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
John Hunter Hospital - Cardiovascular Department
New Lambton Heights, New South Wales, 2305, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Illawarra Heart Health Centre
Wollongong, New South Wales, 2500, Australia
The Prince Charles Hospital
Brisbane, Queensland, 4032, Australia
The Prince Charles Hospital
Brisbane, Queensland, 4032, Australia
Ballarat Base Hospital
Ballarat, Victoria, 3350, Australia
Ballarat Base Hospital
Ballarat, Victoria, 3350, Australia
The Cardiologists Pty Ltd
Epping, Victoria, 3076, Australia
The Cardiologists Pty Ltd
Epping, Victoria, 3076, Australia
Advara HeartCare Mulgrave
Mulgrave, Victoria, 3170, Australia
Advara HeartCare
Mulgrave, Victoria, 3170, Australia
Fiona Stanley Hospital Cardiology
Murdoch, Western Australia, 6150, Australia
MHAT Puls AD, Cardiology Department
Blagoevgrad, 2700, Bulgaria
MHAT Haskovo AD
Haskovo, 6300, Bulgaria
MHAT Heart and Brain EAD - Pleven, Cardiology
Pleven, 5804, Bulgaria
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology
Plovdiv, 4002, Bulgaria
MC Hera EOOD - Sofia
Sofia, 1510, Bulgaria
Medical center ISUL - Tsaritsa Yoanna EOOD
Sofia, 1527, Bulgaria
UMHATEM N.I. Pirogov EAD
Sofia, 1606, Bulgaria
UMHAT Sveta Anna Sofia AD, Clinic of Cardiology
Sofia, 1750, Bulgaria
Medical Center Synexus Sofia EOOD
Sofia, 1784, Bulgaria
University of Calgary_Calgary
Calgary, Alberta, T2N 4Z6, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6, Canada
Saul Vizel Pro. Med. Corp
Cambridge, Ontario, N1R 7R1, Canada
Corcare Cardiovascular Research
Scarborough Village, Ontario, M1B 5N1, Canada
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2, Canada
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2, Canada
CPS Research
Waterloo, Ontario, N2T 0C1, Canada
CPS Research
Waterloo, Ontario, N2T 0C1, Canada
Clinical Research Solutions Inc.
Waterloo, Ontario, N2T OC1, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
CHU de Quebec-Uni Laval-Hotel
Québec, G1R 2J6, Canada
Innera s.r.o.
Benešov, 256 01, Czechia
Kardiologicka ambulance Brno s.r.o.
Brno, 612 00, Czechia
Vojenská nemocnice Brno p.o.
Brno, 61500, Czechia
Ordinace pro choroby srdce
Chomutov, 430 02, Czechia
MEDICON a.s.
Prague, 170 00, Czechia
Svitavska nemocnice Kardiologie
Svitavy, 568 25, Czechia
Kardiologie Trutnov Ferkl
Trutnov, 541 01, Czechia
Nemocnice AGEL Třinec-Podlesí a.s.
Třinec, 739 61, Czechia
Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau
Chambray-lès-Tours, 37170, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35000, France
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
Rouen, 76031, France
Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
Toulon, 83100, France
Polyclinique Vauban
Valenciennes, 59300, France
Chru de Nancy - Hopital Brabois
Vandœuvre-lès-Nancy, 54500, France
Kardiologisch-Angiologische Praxis Herzzentrum Bremen
Bremen, 28277, Germany
Uniklinik TU Dresden - Herzzentrum Dresden GmbH
Dresden, 01307, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, 04910, Germany
Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II
Erfurt, 99097, Germany
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt, 60389, Germany
Universitätsklinikum Freiburg - Medical Center
Freiburg im Breisgau, 79106, Germany
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
Fulda, 36037, Germany
Universität des Saarlandes - Innere Med. III
Homburg, 66421, Germany
Kardiopraxis Schirmer
Kaiserslautern, 67655, Germany
Gesundheitscentrum Mainz (Regner / Schmitt)
Mainz, 55116, Germany
Alexandra General Hospital, Therapeutic Clinic
Athens, Attica, 11528, Greece
Evangelismos Hospital
Athens, 10676, Greece
Naval Hospital of Athens - Clinic of Cardiology
Athens, 11521, Greece
"Laiko" General Hospital of Athens
Athens, 11527, Greece
'G. Gennimatas' General Hospital of Athens - Cardiology Department
Athens, 11527, Greece
'G. Gennimatas' General Hospital of Athens
Athens, 11527, Greece
Konstantopouleio G.H. of Athens, "Agia Olga"
Athens, 14233, Greece
"Hygeia" General Hospital of Athens
Athens, 15123, Greece
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic
Athens, 15562, Greece
Naval Hospital of Athens
Athens, GR-11521, Greece
U.G.H of Athens "Attikon"
Chaidari, Athens, 12462, Greece
U.G.H of Athens "Attikon"
Chaidari, Athens, GR-12462, Greece
General Hospital of Kalamata - Cardiology Department
Chalcis, 34100, Greece
General Hospital of Chios "Skilitsio" - Cardiology Clinic
Chios, 82100, Greece
Univ Gen Hospital Larisa, Cardiology Medicine Clinic
Larissa, 41110, Greece
Sismanogleio General Hospital - Cardiology Department
Marousi, 151 26, Greece
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, 54636, Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, 54642, Greece
Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt
Thessaloniki, 57010, Greece
Siddhartha Medical College & Government General Hospital
Vijaywada, Andhra Pradesh, 520008, India
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002, India
Rhythm Heart Institute
Vadodara, Gujarat, 390022, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, 590010, India
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, 590010, India
St John's Medical College Hospital
Bengaluru, Karnataka, 560034, India
St John's Medical College Hospital
Bengaluru, Karnataka, 560034, India
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bengaluru, Karnataka, 560069, India
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bengaluru, Karnataka, 560069, India
Manipal Hospital, Mysuru
Mysuru, Karnataka, 570015, India
Kasturba Medical College and Hospital, Manipal
Udupi, Karnataka, 576104, India
Kasturba Medical College and Hospital, Manipal
Udupi, Karnataka, 576104, India
Sengupta Hospital and Research Institute
Nagpur, Maharashtra, 440033, India
Sengupta Hospital and Research Institute
Nagpur, Maharashtra, 440033, India
All India Institute of Medical Sciences (AIIMS), Nagpur
Nagpur, Maharashtra, 441108, India
Chopda Medicare and Research Centre Pvt. Ltd.
Nashik, Maharashtra, 422005, India
Chopda Medicare and Research Centre Pvt. Ltd.
Nashik, Maharashtra, 422005, India
Vijan Hospital & Research Centre
Nashik, Maharashtra, 422005, India
Vijan Hospital & Research Centre
Nashik, Maharashtra, 422005, India
Villoo Poonawalla Memorial Hospital
Pune, Maharashtra, 411028, India
G B Pant Institute of Postgraduate Medical Education and Research
New Delhi, National Capital Territory of Delhi, 110002, India
G B Pant Institute of Postgraduate Medical Education and Research
New Delhi, National Capital Territory of Delhi, 110002, India
All India Institute of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110029, India
Vardhaman Mahavir Medical College & Safdarjung Hospital
New Delhi, National Capital Territory of Delhi, 110029, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
Rajiv Gandhi Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, 110093, India
All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Bhubaneswar, Odisha, 751019, India
All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Bhubaneswar, Odisha, 751019, India
S.P. Medical College & Associated Group of Hospitals
Bikaner, Rajasthan, 334003, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry, Tamil Nadu, 605006, India
Guru Nanak CARE Hospitals
Hyderabad, Telangana, 500020, India
Malla Reddy Narayana Multispeciality Hospital
Hyderabad, Telangana, 500055, India
Jawaharlal Nehru Medical College and Hospital
Aligarh, Uttar Pradesh, 202002, India
Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
Kanpur, Uttar Pradesh, 208002, India
Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
Kanpur, Uttar Pradesh, 208002, India
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226010, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014, India
Jawaharlal Nehru Medical College and Hospital
Aligarh, Utter Pradesh, 202002, India
B M Birla Heart Research Centre
Kolkata, West Bengal, 700027, India
Hospital Sultanah Aminah
Johor Bahru, Johor, 80100, Malaysia
Hospital Sultanah Aminah
Johor Bahru, Johor, 80100, Malaysia
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05460, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100, Malaysia
Hospital Raja Permaisuri Bainun Ipoh
Ipoh, Perak, 30450, Malaysia
Hospital Serdang
Kajang, Selangor, 43000, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586, Malaysia
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605, Poland
Kardio Life - Tomasz Borkowski
Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland
Kardio Life
Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland
Cardiomedicum Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 30-002, Poland
Cardiomedicum Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 30-002, Poland
Linden sp. z o.o. sp. k.
Krakow, Lesser Poland Voivodeship, 30-721, Poland
Formed 2 Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, 32-600, Poland
Pratia S.A.
Jelenia Góra, Lower Silesian Voivodeship, 58-506, Poland
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-981, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
Puławy, Lublin Voivodeship, 24-100, Poland
Prywatna Praktyka Lekarska Anna Chudoba
Żyrardów, Masovian Voivodeship, 96-300, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-540, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-540, Poland
Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
Gdynia, Pomeranian Voivodeship, 81-157, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia, Pomeranian Voivodeship, 81-348, Poland
American Heart of Poland S.A.
Bielsko-Biala, 43-316, Poland
10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy
Bydgoszcz, 85-681, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia, 81-348, Poland
Zanamed Medical Clinic Sp. z o.o.
Lublin, 20-601, Poland
Trialmed Sp. z o. o.
Piotrkow Trybunalski, 97-300, Poland
Trialmed Sp. z o. o.
Piotrkow Trybunalski, 97-300, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, 61-848, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, 61-848, Poland
American Heart of Poland S.A.
Tychy, 43-100, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, 02-507, Poland
Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi
Lodz, Łódź Voivodeship, 90-549, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
Lodz, Łódź Voivodeship, 93-513, Poland
CHTâmega e Sousa - Hospital Padre Américo
Guilhufe - Penafiel, 4560-136, Portugal
CHLO, EPE - Hospital São Francisco Xavier
Lisbon, 1449-005, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Centro Hospitalar Lisboa Norte
Lisbon, 1649-035, Portugal
Centro Hospitalar de Setubal
Setúbal, 2910-446, Portugal
Hospital Vithas Sevilla
Castilleja de la Cuesta, Andalusia, 41950, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Gregorio Marañón
Madrid, 28007, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
H Virgen del Camino_Sanlúcar_Medicina Interna
Sanlúcar de Barrameda, 11540, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, 41003, Spain
Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA)
Valencia, 46010, Spain
Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji
Eskişehir, Odunpazari, 26040, Turkey (Türkiye)
T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
Adana, 01000, Turkey (Türkiye)
Adana Şehir Eğitim ve Araştırma Hastanesi
Adana, 01060, Turkey (Türkiye)
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200, Turkey (Türkiye)
Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji
Afyonkarahisar, 03200, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Kardiyoloji
Ankara, 06800, Turkey (Türkiye)
Ankara Sehir Hastanesi Cardiology
Ankara, 06800, Turkey (Türkiye)
Bursa Şehir Hastanesi- Kardiyoloji
Bursa, 16110, Turkey (Türkiye)
Trakya University
Edirne, 22030, Turkey (Türkiye)
Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji
Edirne, 22030, Turkey (Türkiye)
Başakşehir Çam ve Sakura Şehir Hastanesi
Istanbul, 34480, Turkey (Türkiye)
Erciyes University Cardiology
Kayseri, 38039, Turkey (Türkiye)
Erciyes Üniversitesi Hastanesi- Kardiyoloji
Kayseri, 38039, Turkey (Türkiye)
Kocaeli Üniversitesi Hastanesi- Kardiyoloji
Kocaeli, 41380, Turkey (Türkiye)
Raigmore Hospital
Inverness, Highland, IV2 3JH, United Kingdom
St. Richard's Hospital_Cardiology
Chichester, West Sussex, PO19 6SE, United Kingdom
FutureMeds
Birmingham, B21 9RY, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Peterborough City Hospital
Peterborough, PE3 9GZ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency dept. 2834
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2023
First Posted
January 10, 2024
Study Start
April 1, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
January 8, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com