A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
Launched by NOVO NORDISK A/S · Dec 28, 2023
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medicine called ziltivekimab to see how well it works for people with heart failure and inflammation. Participants in the study will either receive ziltivekimab or a placebo, which is a substance that looks like the medicine but doesn’t contain any active ingredients. The choice of which treatment a participant receives is made randomly, meaning everyone has an equal chance of getting either the active medicine or the placebo. This trial is not yet complete, and ziltivekimab is not available for doctors to prescribe anywhere in the world. The study will last for about 1 year and 4 months.
To be eligible for this trial, participants should be between 65 and 74 years old and have specific health markers related to heart failure, such as certain levels of blood proteins and heart measurements. They should not have had any recent serious heart issues or hospital visits for heart failure. Participants can expect to be monitored closely during the trial, including tests to measure their heart function and overall health. This trial aims to provide important information about ziltivekimab's safety and effectiveness for treating heart failure with inflammation.
Gender
ALL
Eligibility criteria
- 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
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Montreal, Quebec, Canada
Athens, , Greece
Saint Louis, Missouri, United States
Montreal, Quebec, Canada
Richmond, Virginia, United States
Salamanca, , Spain
Reno, Nevada, United States
Philadelphia, Pennsylvania, United States
Dundee, , United Kingdom
Dresden, , Germany
Dundee, , United Kingdom
Santiago De Compostela, , Spain
Madrid, , Spain
Madrid, , Spain
New Lambton Heights, New South Wales, Australia
Kansas City, Missouri, United States
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Ballarat, Victoria, Australia
Poitiers, , France
Homburg, , Germany
Poitiers, , France
Freiburg, , Germany
Oxon Hill, Maryland, United States
Visakhapatnam, Andhra Pradesh, India
Tomball, Texas, United States
Brisbane, Queensland, Australia
Warszawa, , Poland
Kocaeli, , Turkey
Pulawy, , Poland
Dallas, Texas, United States
Johor Bahru, Johor, Malaysia
Kuantan, Pahang, Malaysia
Chapel Hill, North Carolina, United States
Valencia, , Spain
Louisville, Kentucky, United States
Lucknow, Uttar Pradesh, India
Sevilla, , Spain
Majadahonda, Madrid, Spain
Kuala Lumpur, , Malaysia
Elsterwerda, , Germany
Sanlúcar De Barrameda, , Spain
Dresden, , Germany
Lisboa, , Portugal
Kajang, Selangor, Malaysia
Haskovo, , Bulgaria
Morón, , Argentina
Lisboa, , Portugal
New Delhi, Delhi, India
Peterborough, , United Kingdom
Northridge, California, United States
Clearwater, Florida, United States
Buenos Aires, , Argentina
Santiago De Compostela, , Spain
Chalkida, , Greece
Serdang, , Malaysia
Chichester, West Sussex, United Kingdom
Edirne, , Turkey
Salta, , Argentina
Larissa, , Greece
Kuantan, , Malaysia
Amarillo, Texas, United States
Cambridge, Ontario, Canada
Valenciennes, , France
Vadodara, Gujarat, India
Alexander City, Alabama, United States
Alor Setar, Kedah, Malaysia
Kocaeli, , Turkey
Visakhapatnam, Andra Pradesh, India
Salamanca, Castilla Y León, Spain
Trutnov, , Czechia
Brno, , Czechia
Kajang, , Malaysia
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Ormond Beach, Florida, United States
Kolkata, West Bengal, India
Athens, , Greece
Athens, , Greece
Toronto, Ontario, Canada
Kaiserslautern, , Germany
Toronto, Ontario, Canada
Rouen Cedex, , France
Edirne, , Turkey
Sherman, Texas, United States
Hazel Crest, Illinois, United States
Thessaloniki, , Greece
Saint Augustine, Florida, United States
Hazel Crest, Illinois, United States
Svitavy, , Czechia
Frankfurt, , Germany
Chios, , Greece
Nashik, Maharashtra, India
Bikaner, Rajasthan, India
West Sussex, , United Kingdom
Setubal, , Portugal
Murdoch, Western Australia, Australia
Scarborough, Ontario, Canada
Nashik, Maharashtra, India
Adana, , Turkey
Udupi, Karnataka, India
Ocala, Florida, United States
Amarillo, Texas, United States
Kaiserslautern, , Germany
New Delhi, Delhi, India
Brno, , Czechia
Sevilla, , Spain
Amarillo, Texas, United States
Norfolk, Virginia, United States
Fairhope, Alabama, United States
Praha 7, , Czechia
Gdynia, , Poland
Ipoh, Perak, Malaysia
Largo, Florida, United States
Istanbul, , Turkey
Chaidari, Athens, , Greece
Bydgoszcz, , Poland
Waterloo, Ontario, Canada
Afyon, , Turkey
Orange, California, United States
Salta, , Argentina
Thessaloniki, , Greece
Vadodara, Gujarat, India
Guilhufe Penafiel, , Portugal
Lisbon, , Portugal
Sofia, , Bulgaria
New Delhi, Delhi, India
Haskovo, , Bulgaria
San Miguel De Tucumán, Tucumán., , Argentina
Puducherry, , India
Afyon, , Turkey
Lodz, Lodzkie, Poland
Athens, Attiki, Greece
Waterloo, Ontario, Canada
El Paso, Texas, United States
Poznan, , Poland
New Delhi, Delhi, India
Istanbul, , Turkey
Rennes, , France
Udupi, Karnataka, India
Kanpur, Uttar Pradesh, India
Lucknow, Uttar Pradesh, India
Warszawa, , Poland
Poznan, , Poland
Nagpur, Maharashtra, India
Bhubaneswar, Odisha, India
Hyderabad, Telangana, India
Aligarh, Uttar Pradesh, India
Vijaywada, Andhra Pradesh, India
Johor Bahru, Johor, Malaysia
Alor Setar, Kedah, Malaysia
Bengaluru, Karnataka, India
Elsterwerda, , Germany
Kraków, Małopolskie, Poland
Kraków, , Poland
San Antonio, Texas, United States
Morón, , Argentina
Waterloo, Ontario, Canada
Frankfurt, , Germany
Nagpur, Maharashtra, India
Lodz, Lodzkie, Poland
żyrardów, Masovian, Poland
Bielsko Biała, , Poland
Lublin, , Poland
Sanlúcar De Barrameda, , Spain
Eskisehir, Odunpazari, Turkey
Adana, , Turkey
Kayseri, , Turkey
West Sussex, , United Kingdom
Athens, , Greece
Caba, , Argentina
New Lambton Heights, New South Wales, Australia
Brisbane, Queensland, Australia
Ballarat, Victoria, Australia
Epping, Victoria, Australia
Brno, , Czechia
Rouen Cedex, , France
Toulon, , France
Vandoeuvre Les Nancy, , France
Belagavi, Karnataka, India
Mysuru, Karnataka, India
Pune, Maharashtra, India
Ipoh, Perak, Malaysia
Kota Bharu, Kelantan, , Malaysia
Białystok, Podlaskie, Poland
Jelenia Góra, , Poland
Kraków, , Poland
Salamanca, Castilla Y León, Spain
Bursa, , Turkey
Inverness, Highland, United Kingdom
Peterborough, , United Kingdom
Lisboa, , Portugal
Buenos Aires, , Argentina
Sofia, , Bulgaria
Larissa, , Greece
Athens, , Greece
Athens, , Greece
Chios, , Greece
Lake Success, New York, United States
Garran, Australian Capital Territory, Australia
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Chomutov, , Czechia
Svitavy, , Czechia
Bengaluru, Karnataka, India
Hyderabad, Telangana, India
Kolkata, West Bengal, India
Athens, , Greece
New York, New York, United States
San Miguel De Tucumán, Tucumán., , Argentina
Wollongong, New South Wales, Australia
Pleven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Homburg, , Germany
Thessaloniki, , Greece
New Delhi, Delhi, India
Bengaluru, Karnataka, India
Nashik, Maharashtra, India
Włocławek, Kujawsko Pomorskie, Poland
Lodz, Lodzkie, Poland
Gdynia, , Poland
Guilhufe Penafiel, , Portugal
Lisbon, , Portugal
Setubal, , Portugal
Ankara, , Turkey
Alexander City, Alabama, United States
Fairhope, Alabama, United States
Little Rock, Arkansas, United States
Saint Augustine, Florida, United States
Macon, Georgia, United States
El Paso, Texas, United States
Calgary, Alberta, Canada
Trutnov, , Czechia
Bremen, , Germany
Freiburg, , Germany
Athens, Attiki, Greece
Athens, , Greece
Chaidari, Athens, , Greece
Thessaloniki, , Greece
Vijaywada, Andhra Pradesh, India
Nagpur, Maharashtra, India
Blagoevgrad, , Bulgaria
New Delhi, Delhi, India
Bhubaneswar, Odisha, India
Bikaner, Rajasthan, India
Hyderabad, Telangana, India
Aligarh, Uttar Pradesh, India
Kanpur, Uttar Pradesh, India
Lucknow, Uttar Pradesh, India
Puducherry, , India
Pulawy, Lubelskie, Poland
Gdynia, Pomorskie, Poland
Lanus Este, , Argentina
Rennes, , France
Homburg, , Germany
Wroclaw, Dolnoslaskie, Poland
Cambridge, Ontario, Canada
Inverness, Highland, United Kingdom
Savannah, Georgia, United States
Baltimore, Maryland, United States
Riverhead, New York, United States
Dallas, Texas, United States
Buenos Aires, , Argentina
Caba, , Argentina
Epping, Victoria, Australia
Murdoch, Western Australia, Australia
Quebec, , Canada
Praha 7, , Czechia
Toulon, , France
Vandoeuvre Les Nancy, , France
Belagavi, Karnataka, India
Mysuru, Karnataka, India
Pune, Maharashtra, India
Bhubaneswar, Odisha, India
Ipoh, Perak, Malaysia
Kota Bharu, Kelantan, , Malaysia
Jelenia Góra, Dolnoslaskie, Poland
Bydgoszcz, Kujawsko Pomorskie, Poland
Kraków, Malopolskie, Poland
Białystok, Podlaskie, Poland
Sevilla, , Spain
Valencia, , Spain
Bursa, , Turkey
Horsham, Pennsylvania, United States
Louisville, Kentucky, United States
Chambray Les Tours, , France
Marousi, , Greece
Bydgoszcz, , Poland
Pasadena, California, United States
Savannah, Georgia, United States
Bloomfield Hills, Michigan, United States
Reno, Nevada, United States
Katy, Texas, United States
Epping, Victoria, Australia
Waterloo, Ontario, Canada
Aligarh, Uttar Pradesh, India
Oswiecim, , Poland
Larissa, , Greece
Savannah, Georgia, United States
Chapel Hill, North Carolina, United States
Oswiecim, Malopolskie, Poland
Lanus Este, Buenos Aires, Argentina
Bikaner, Rajasthan, India
Thessaloniki, , Greece
Sofia, , Bulgaria
Buenos Aires, , Argentina
Farmington Hills, Michigan, United States
Pleven, , Bulgaria
Kanpur, Uttar Pradesh, India
Majadahonda, Madrid, Spain
Birmingham, , United Kingdom
Castilleja De La Cuesta. Sevilla, , Spain
Włocławek, Kujawsko Pomorskie, Poland
Aligarh, Utter Pradesh, India
Benešov, , Czechia
Třinec, , Czechia
Athens, , Greece
Lodz, Lodzkie, Poland
Castilleja De La Cuesta. Sevilla, Andalucia, Spain
Farmington Hills, Michigan, United States
Pleven, , Bulgaria
Brno, , Czechia
Praha 7, , Czechia
Erfurt, , Germany
Fulda, , Germany
Mainz, , Germany
Piotrków Trybunalski, , Poland
Tychy, , Poland
Chios, , Greece
Thessaloniki, , Greece
Athens, Attiki, Greece
Esperanza, Santa Fe, , Argentina
Athens, , Greece
Athens, , Greece
Athens, , Greece
Chaidari, Athens, , Greece
Larissa, , Greece
Gdynia, Pomorskie, Poland
Mulgrave, Victoria, Australia
City Of Buenos Aires, , Argentina
Castilleja De La Cuesta. Sevilla, Andalucia, Spain
Patients applied
Trial Officials
Clinical Transparency dept. 2834
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported