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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06200207




Registration number
NCT06200207
Ethics application status
Date submitted
28/12/2023
Date registered
10/01/2024
Date last updated
8/10/2024

Titles & IDs
Public title
A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
Scientific 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
Secondary ID [1] 0 0
U1111-1293-7516
Secondary ID [2] 0 0
NN6018-4914
Universal Trial Number (UTN)
Trial acronym
ATHENA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Systemic Inflammation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ziltivekimab
Treatment: Drugs - Placebo

Active comparator: Ziltivekimab - Participants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months.

Placebo comparator: Placebo - Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months.


Treatment: Drugs: Ziltivekimab
Zilitivekimab will be administered subcutaneously once-monthly.

Treatment: Drugs: Placebo
Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
Timepoint [1] 0 0
From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcome [1] 0 0
Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
Timepoint [1] 0 0
From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcome [2] 0 0
Participant achieving threshold for clinically meaningful within-participant change in 6-minute walk distance (6MWD) (yes/no)
Timepoint [2] 0 0
From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcome [3] 0 0
Participants improving 5 points or more in KCCQ-CSS (yes/no)
Timepoint [3] 0 0
From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcome [4] 0 0
Participants improving 10 points or more in KCCQ-CSS (yes/no)
Timepoint [4] 0 0
From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcome [5] 0 0
Change in subscales of KCCQ (total symptom score, physical limitations score, social limitations score, and health-related quality of life)
Timepoint [5] 0 0
From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcome [6] 0 0
Change in six-minute walk distance (6MWD)
Timepoint [6] 0 0
From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcome [7] 0 0
Change in high-sensitivity C-reactive protein (hs-CRP)
Timepoint [7] 0 0
From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcome [8] 0 0
Participants experiencing improvement in New York heart association (NYHA) Class (yes/no)
Timepoint [8] 0 0
From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcome [9] 0 0
Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP)
Timepoint [9] 0 0
From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcome [10] 0 0
Change in eGFR (CKD-EPI)
Timepoint [10] 0 0
From randomisation (month 0) to end-of-treatment (month 12)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/09/2026
Actual
Sample size
Target
680
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Illawarra Heart Health Centre - Wollongong
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [4] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [5] 0 0
The Cardiologists Pty Ltd - Epping
Recruitment hospital [6] 0 0
Fiona Stanley Hospital Cardiology - Murdoch
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4032 - Brisbane
Recruitment postcode(s) [4] 0 0
3350 - Ballarat
Recruitment postcode(s) [5] 0 0
3076 - Epping
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
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Kentucky
Country [8] 0 0
United States of America
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Maryland
Country [9] 0 0
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Michigan
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Missouri
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Nevada
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New York
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North Carolina
Country [14] 0 0
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Pennsylvania
Country [15] 0 0
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Morón
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Argentina
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Salta
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Argentina
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San Miguel De Tucumán, Tucumán.
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Haskovo
Country [23] 0 0
Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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Ontario
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Quebec
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Czechia
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Brno
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Czechia
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Chomutov
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Czechia
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Praha 7
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Czechia
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Svitavy
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Czechia
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Trutnov
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France
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Chambray Les Tours
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France
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Poitiers
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France
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Rennes
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France
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Rouen cedex
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France
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Toulon
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France
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Vandoeuvre Les Nancy
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Germany
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Bremen
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Germany
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Dresden
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Germany
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Elsterwerda
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Homburg
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Germany
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Kaiserslautern
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Greece
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Attiki
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Greece
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Athens
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Greece
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Chaidari, Athens
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Greece
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Chios
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Greece
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Larissa
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Greece
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Marousi
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Greece
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Thessaloniki
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India
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Andhra Pradesh
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Delhi
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Gujarat
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Karnataka
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Odisha
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India
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Rajasthan
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India
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Telangana
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India
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Uttar Pradesh
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Utter Pradesh
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West Bengal
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Puducherry
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Johor
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Kedah
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Pahang
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Perak
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Malaysia
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Wilayah Persekutuan Kuala Lumpur
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Kajang
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Malaysia
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Kota Bharu, Kelantan
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Dolnoslaskie
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Lodzkie
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Lubelskie
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Podlaskie
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Pomorskie
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Bydgoszcz
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Gdynia
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Poland
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Poznan
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Poland
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Warszawa
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Portugal
State/province [86] 0 0
Guilhufe - Penafiel
Country [87] 0 0
Portugal
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Lisboa
Country [88] 0 0
Portugal
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Lisbon
Country [89] 0 0
Portugal
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Setubal
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Spain
State/province [90] 0 0
Castilla Y León
Country [91] 0 0
Spain
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Madrid
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Spain
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Castilleja De La Cuesta. Sevilla
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Spain
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Sanlúcar de Barrameda
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Spain
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Santiago de Compostela
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Spain
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Sevilla
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Spain
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Valencia
Country [97] 0 0
Turkey
State/province [97] 0 0
Odunpazari
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Turkey
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Adana
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Turkey
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Afyon
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Turkey
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Ankara
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Turkey
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Bursa
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Kayseri
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Turkey
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Kocaeli
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Highland
Country [107] 0 0
United Kingdom
State/province [107] 0 0
West Sussex
Country [108] 0 0
United Kingdom
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Birmingham
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United Kingdom
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Dundee
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United Kingdom
State/province [110] 0 0
Peterborough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT06200207
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency dept. 2834
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06200207