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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05636176




Registration number
NCT05636176
Ethics application status
Date submitted
23/11/2022
Date registered
5/12/2022

Titles & IDs
Public title
A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation
Scientific title
Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Secondary ID [1] 0 0
U1111-1280-0810
Secondary ID [2] 0 0
EX6018-4915
Universal Trial Number (UTN)
Trial acronym
HERMES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 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

Experimental: Ziltivekimab - Participants will receive ziltivekimab subcutaneous (s.c.) injection once-monthly and added standard of care for up to 4 years.

Placebo comparator: Placebo - Participants will receive ziltivekimab placebo s.c. injection once-monthly and added standard of care for up to 4 years.


Treatment: Drugs: Ziltivekimab
Ziltivekimab subcutaneous (s.c.) injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years.

Treatment: Drugs: Placebo
Ziltivekimab placebo s.c. injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of a Composite Heart Failure Endpoint Consisting of: Cardiovascular (CV) Death, Heart Failure (HF) Hospitalisation or Urgent HF Visit
Timepoint [1] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [1] 0 0
Time to First Occurrence of 4-point Expanded Composite HF Endpoint, a Composite Endpoint Consisting of: CV Death, HF Hospitalisation or Urgent HF Visit, Non-fatal Myocardial Infarction (MI), Non-fatal Stroke
Timepoint [1] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [2] 0 0
Number of CV Deaths, HF Hospitalisations or Urgent HF Visits (First and Recurrent)
Timepoint [2] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [3] 0 0
Time to Occurrence of CV Death
Timepoint [3] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [4] 0 0
Time to Occurrence of all-cause Death
Timepoint [4] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [5] 0 0
Time to First Occurrence of 4-point Expanded Composite HF Endpoint, a Composite Endpoint Consisting of: All-cause Death, HF Hospitalisation or Urgent HF Visit, Non-fatal MI, Non-fatal stroke
Timepoint [5] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [6] 0 0
Hierarchical Composite of: Time to All-cause Death, Number of HF Hospitalisations or Urgent HF Visits, Time to First HF Hospitalisation or Urgent HF Visit, difference of at least 5 in KCCQ clinical summary score change from baseline to 12 months
Timepoint [6] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [7] 0 0
Time to First Occurrence of HF Hospitalisation or Urgent HF Visit
Timepoint [7] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [8] 0 0
Number of Events of Atrial Fibrillation
Timepoint [8] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [9] 0 0
Change in KCCQ Clinical Summary Score
Timepoint [9] 0 0
From randomisation (month 0) to 12 months
Secondary outcome [10] 0 0
Improvement of 5 Points or More in KCCQ Clinical Summary Score (Yes/No)
Timepoint [10] 0 0
From randomisation (month 0) to 12 months
Secondary outcome [11] 0 0
Improvement of 10 Points or More in KCCQ Clinical Summary Score (Yes/No)
Timepoint [11] 0 0
From randomisation (month 0) to 12 months
Secondary outcome [12] 0 0
Improvement in New York Heart Association (Classification) [NYHA Class] (Yes/No)
Timepoint [12] 0 0
From randomisation (month 0) to 12 months
Secondary outcome [13] 0 0
Time to First Occurrence of a Composite Chronic Kidney Disease (CKD) Endpoint Consisting of: CV death, Onset of Persistent Greater Than Equal To 40 Percentage Reduction in eGFR (CKD- EPI) compared with baseline; Kidney failure
Timepoint [13] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [14] 0 0
Change in Estimated Glomerular Filtration Rate (eGFR) (Chronic Kidney Disease - Epidemiology Collaboration [CKD-EPI])
Timepoint [14] 0 0
From randomisation (month 0) to 12 months
Secondary outcome [15] 0 0
Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)
Timepoint [15] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [16] 0 0
Number of Hospitalisations With Infection as Primary Cause or Death Due to Infection
Timepoint [16] 0 0
From randomisation (month 0) to end of study (up to 48 months)
Secondary outcome [17] 0 0
Change in High-sensitivity C-reactive Protein (hs-CRP)
Timepoint [17] 0 0
From randomisation (month 0) to 12 months
Secondary outcome [18] 0 0
Change in N-terminal-pro-brain Natriuretic Peptide (NT-proBNP)
Timepoint [18] 0 0
From randomisation (month 0) to 12 months

Eligibility
Key inclusion criteria
* Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2 milligrams per liter (mg/L) at screening (visit 1) Disease specific - cardiovascular
* At least one of the following:

1. N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than equal to 300 picograms per milliliter (pg/mL) at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NTproBNP must be greater than equal to 600 pg/mL. Note that the screening electrocardiogram (ECG) must be obtained the same day as sampling for NT-proBNP.
2. Hospitalisation or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than equal to 600 pg/mL.
* Diagnosis of heart failure (New York Heart Association [classification] [NYHA] Class II-IV).
* Left ventricular ejection fraction (LVEF) greater than 40 percentage (%) 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 (e.g., 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 meter square (mL/m^2).
* LA diameter greater than equal to 3.8 centimeter (cm).
* LA length greater than equal to 5.0 cm.
* LA area greater than equal to 20 cm square.
* LA volume greater than equal to 55 milliters (mL).
* Intraventricular septal thickness greater than equal to 1.1 cm.
* Posterior wall thickness greater than equal to 1.1 cm.
* Left ventricular (LV) mass index greater than equal to 115 grams per meter square (g/m^2 ) in men or greater than equal to 95 g/m^2 in women.
* E/e' (mean septal and lateral) greater than equal to 10.
* e' (mean septal and lateral) less than 9 centimeter per second (cm/s).
* No heart failure hospitalisations or urgent heart failure visits between screening (visit 1) and randomisation (visit 2).
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 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 equal to 3 antihypertensive drugs. (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
* Heart rate above 110 or below 40 beats per minute as evaluated on the electrocardiogram (ECG) performed at screening (visit 1) (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
* Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (Note: Planned coronary angiogram is not exclusionary).
* 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 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
8/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/07/2027
Actual
Sample size
Target
5600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital_Garran - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Cardiology - Concord
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [5] 0 0
Heart of Australia - Chelmer
Recruitment hospital [6] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [7] 0 0
Nightingale Research - Adelaide
Recruitment hospital [8] 0 0
Royal Adelaide Hospital Cardiovascular Clinical Trials - Adelaide
Recruitment hospital [9] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 0 0
Frankston Hospital - Frankston
Recruitment hospital [12] 0 0
Barwon Health (The Geelong Hospital) - Geelong
Recruitment hospital [13] 0 0
Epworth HealthCare - Richmond
Recruitment hospital [14] 0 0
Clinitrials - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
4029 - Brisbane
Recruitment postcode(s) [5] 0 0
4068 - Chelmer
Recruitment postcode(s) [6] 0 0
4814 - Douglas
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
3199 - Frankston
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
3121 - Richmond
Recruitment postcode(s) [13] 0 0
6000 - Perth
Recruitment outside Australia
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Alabama
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Arizona
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Policka
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Praha 1
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Czechia
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Czechia
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Slany
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Tabor
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Trutnov
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Uherske Hradiste
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Aarhus N
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Tallinn
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HUS
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Seinäjoki
Country [152] 0 0
Finland
State/province [152] 0 0
Tampere
Country [153] 0 0
Finland
State/province [153] 0 0
Turku
Country [154] 0 0
France
State/province [154] 0 0
La Tronche
Country [155] 0 0
France
State/province [155] 0 0
Montpellier
Country [156] 0 0
France
State/province [156] 0 0
Paris
Country [157] 0 0
France
State/province [157] 0 0
Poitiers
Country [158] 0 0
France
State/province [158] 0 0
Toulouse
Country [159] 0 0
Germany
State/province [159] 0 0
Aachen
Country [160] 0 0
Germany
State/province [160] 0 0
Berlin
Country [161] 0 0
Germany
State/province [161] 0 0
Bremen
Country [162] 0 0
Germany
State/province [162] 0 0
Dortmund
Country [163] 0 0
Germany
State/province [163] 0 0
Dresden
Country [164] 0 0
Germany
State/province [164] 0 0
Elsterwerda
Country [165] 0 0
Germany
State/province [165] 0 0
Frankfurt am Main
Country [166] 0 0
Germany
State/province [166] 0 0
Frankfurt
Country [167] 0 0
Germany
State/province [167] 0 0
Freiburg
Country [168] 0 0
Germany
State/province [168] 0 0
Giessen
Country [169] 0 0
Germany
State/province [169] 0 0
Göttingen
Country [170] 0 0
Germany
State/province [170] 0 0
Hamburg
Country [171] 0 0
Germany
State/province [171] 0 0
Hassloch
Country [172] 0 0
Germany
State/province [172] 0 0
Homburg
Country [173] 0 0
Germany
State/province [173] 0 0
Jena
Country [174] 0 0
Germany
State/province [174] 0 0
Kaiserslautern
Country [175] 0 0
Germany
State/province [175] 0 0
Leipzig
Country [176] 0 0
Germany
State/province [176] 0 0
Mannheim
Country [177] 0 0
Germany
State/province [177] 0 0
München
Country [178] 0 0
Germany
State/province [178] 0 0
Papenburg
Country [179] 0 0
Germany
State/province [179] 0 0
Wermsdorf
Country [180] 0 0
Germany
State/province [180] 0 0
Würzburg
Country [181] 0 0
Greece
State/province [181] 0 0
Attiki
Country [182] 0 0
Greece
State/province [182] 0 0
Crete
Country [183] 0 0
Greece
State/province [183] 0 0
Ampelokipoi/Athens
Country [184] 0 0
Greece
State/province [184] 0 0
Athens
Country [185] 0 0
Greece
State/province [185] 0 0
Chaidari, Athens
Country [186] 0 0
Greece
State/province [186] 0 0
Chios
Country [187] 0 0
Greece
State/province [187] 0 0
Larissa
Country [188] 0 0
Greece
State/province [188] 0 0
Piraeus
Country [189] 0 0
Greece
State/province [189] 0 0
Pylea, Thessaloniki
Country [190] 0 0
Greece
State/province [190] 0 0
Rio Patras
Country [191] 0 0
Greece
State/province [191] 0 0
Thessaloniki
Country [192] 0 0
Hungary
State/province [192] 0 0
Baranya Megye
Country [193] 0 0
Hungary
State/province [193] 0 0
Bács-Kiskun Vármegye
Country [194] 0 0
Hungary
State/province [194] 0 0
Békés Megye
Country [195] 0 0
Hungary
State/province [195] 0 0
Csongrád-Csanád
Country [196] 0 0
Hungary
State/province [196] 0 0
Komárom-Esztergom
Country [197] 0 0
Hungary
State/province [197] 0 0
Somogy Megye
Country [198] 0 0
Hungary
State/province [198] 0 0
Zala Megye
Country [199] 0 0
Hungary
State/province [199] 0 0
Baja
Country [200] 0 0
Hungary
State/province [200] 0 0
Budapest
Country [201] 0 0
Hungary
State/province [201] 0 0
Pécs
Country [202] 0 0
India
State/province [202] 0 0
Andhra Pradesh
Country [203] 0 0
India
State/province [203] 0 0
Assam
Country [204] 0 0
India
State/province [204] 0 0
Delhi
Country [205] 0 0
India
State/province [205] 0 0
Gujarat
Country [206] 0 0
India
State/province [206] 0 0
Haryana
Country [207] 0 0
India
State/province [207] 0 0
Karnataka
Country [208] 0 0
India
State/province [208] 0 0
Kerala
Country [209] 0 0
India
State/province [209] 0 0
Maharashtra
Country [210] 0 0
India
State/province [210] 0 0
New Delhi
Country [211] 0 0
India
State/province [211] 0 0
Punjab
Country [212] 0 0
India
State/province [212] 0 0
Rajasthan
Country [213] 0 0
India
State/province [213] 0 0
Tamil Nadu
Country [214] 0 0
India
State/province [214] 0 0
Telangana
Country [215] 0 0
India
State/province [215] 0 0
Telengana
Country [216] 0 0
India
State/province [216] 0 0
Uttar Pradesh
Country [217] 0 0
India
State/province [217] 0 0
Uttarakhand
Country [218] 0 0
India
State/province [218] 0 0
West Bengal
Country [219] 0 0
India
State/province [219] 0 0
Aligarh
Country [220] 0 0
India
State/province [220] 0 0
Bengaluru
Country [221] 0 0
India
State/province [221] 0 0
Palakkad
Country [222] 0 0
India
State/province [222] 0 0
Puducherry
Country [223] 0 0
Ireland
State/province [223] 0 0
Leinster
Country [224] 0 0
Ireland
State/province [224] 0 0
Cork
Country [225] 0 0
Ireland
State/province [225] 0 0
Dublin
Country [226] 0 0
Ireland
State/province [226] 0 0
Mahon, Cork
Country [227] 0 0
Israel
State/province [227] 0 0
Hadera
Country [228] 0 0
Israel
State/province [228] 0 0
Haifa
Country [229] 0 0
Israel
State/province [229] 0 0
Jerusalem
Country [230] 0 0
Israel
State/province [230] 0 0
Petah-Tikva
Country [231] 0 0
Israel
State/province [231] 0 0
Rehovot
Country [232] 0 0
Israel
State/province [232] 0 0
Tel Aviv
Country [233] 0 0
Israel
State/province [233] 0 0
Tel Hashomer
Country [234] 0 0
Israel
State/province [234] 0 0
Zrifin
Country [235] 0 0
Italy
State/province [235] 0 0
Al
Country [236] 0 0
Italy
State/province [236] 0 0
Bg
Country [237] 0 0
Italy
State/province [237] 0 0
Bn
Country [238] 0 0
Italy
State/province [238] 0 0
Bs
Country [239] 0 0
Italy
State/province [239] 0 0
Ce
Country [240] 0 0
Italy
State/province [240] 0 0
Cz
Country [241] 0 0
Italy
State/province [241] 0 0
Fe
Country [242] 0 0
Italy
State/province [242] 0 0
Ge
Country [243] 0 0
Italy
State/province [243] 0 0
Pg
Country [244] 0 0
Italy
State/province [244] 0 0
Pi
Country [245] 0 0
Italy
State/province [245] 0 0
Rm
Country [246] 0 0
Italy
State/province [246] 0 0
Si
Country [247] 0 0
Italy
State/province [247] 0 0
To
Country [248] 0 0
Italy
State/province [248] 0 0
Vr
Country [249] 0 0
Italy
State/province [249] 0 0
Foggia
Country [250] 0 0
Italy
State/province [250] 0 0
Milano
Country [251] 0 0
Italy
State/province [251] 0 0
Monza
Country [252] 0 0
Italy
State/province [252] 0 0
Napoli
Country [253] 0 0
Italy
State/province [253] 0 0
Novara
Country [254] 0 0
Italy
State/province [254] 0 0
Pavia
Country [255] 0 0
Italy
State/province [255] 0 0
Trieste
Country [256] 0 0
Japan
State/province [256] 0 0
Ehime
Country [257] 0 0
Japan
State/province [257] 0 0
Kanagawa
Country [258] 0 0
Japan
State/province [258] 0 0
Bunkyo-ku, Tokyo
Country [259] 0 0
Japan
State/province [259] 0 0
Fukuoka-shi, Fukuoka
Country [260] 0 0
Japan
State/province [260] 0 0
Fukuoka
Country [261] 0 0
Japan
State/province [261] 0 0
Gifu
Country [262] 0 0
Japan
State/province [262] 0 0
Hamamatsu-shi, Shizuoka
Country [263] 0 0
Japan
State/province [263] 0 0
Himeji-shi, Hyogo
Country [264] 0 0
Japan
State/province [264] 0 0
Hokkaido
Country [265] 0 0
Japan
State/province [265] 0 0
Hyogo
Country [266] 0 0
Japan
State/province [266] 0 0
Ibaraki
Country [267] 0 0
Japan
State/province [267] 0 0
Imabari-shi, Ehime
Country [268] 0 0
Japan
State/province [268] 0 0
Ishikawa
Country [269] 0 0
Japan
State/province [269] 0 0
Kagawa
Country [270] 0 0
Japan
State/province [270] 0 0
Kagoshima
Country [271] 0 0
Japan
State/province [271] 0 0
Kishiwada-shi, Osaka
Country [272] 0 0
Japan
State/province [272] 0 0
Kitakyushu-shi, Fukuoka
Country [273] 0 0
Japan
State/province [273] 0 0
Kyoto
Country [274] 0 0
Japan
State/province [274] 0 0
Mie
Country [275] 0 0
Japan
State/province [275] 0 0
Miyagi
Country [276] 0 0
Japan
State/province [276] 0 0
Morioka-shi, Iwate
Country [277] 0 0
Japan
State/province [277] 0 0
Nagasaki
Country [278] 0 0
Japan
State/province [278] 0 0
Okayama-shi, Okayama
Country [279] 0 0
Japan
State/province [279] 0 0
Okayama
Country [280] 0 0
Japan
State/province [280] 0 0
Osaka
Country [281] 0 0
Japan
State/province [281] 0 0
Saga
Country [282] 0 0
Japan
State/province [282] 0 0
Shizuoka
Country [283] 0 0
Japan
State/province [283] 0 0
Takamatsu-shi, Kagawa
Country [284] 0 0
Japan
State/province [284] 0 0
Tokyo
Country [285] 0 0
Japan
State/province [285] 0 0
Tottori
Country [286] 0 0
Japan
State/province [286] 0 0
Toyama
Country [287] 0 0
Japan
State/province [287] 0 0
Yamaguchi
Country [288] 0 0
Japan
State/province [288] 0 0
Yokohama-shi, Kanagawa
Country [289] 0 0
Korea, Republic of
State/province [289] 0 0
Busan
Country [290] 0 0
Korea, Republic of
State/province [290] 0 0
Cheongju
Country [291] 0 0
Korea, Republic of
State/province [291] 0 0
Daegu
Country [292] 0 0
Korea, Republic of
State/province [292] 0 0
Gwangju
Country [293] 0 0
Korea, Republic of
State/province [293] 0 0
Gyeonggi-do
Country [294] 0 0
Korea, Republic of
State/province [294] 0 0
Gyeonggi-Do
Country [295] 0 0
Korea, Republic of
State/province [295] 0 0
Incheon
Country [296] 0 0
Korea, Republic of
State/province [296] 0 0
Seoul
Country [297] 0 0
Korea, Republic of
State/province [297] 0 0
Wonju
Country [298] 0 0
Latvia
State/province [298] 0 0
Jelgava
Country [299] 0 0
Latvia
State/province [299] 0 0
Riga
Country [300] 0 0
Lithuania
State/province [300] 0 0
Kaunas
Country [301] 0 0
Lithuania
State/province [301] 0 0
Klaipeda
Country [302] 0 0
Lithuania
State/province [302] 0 0
Siauliai
Country [303] 0 0
Lithuania
State/province [303] 0 0
Vilnius
Country [304] 0 0
Malaysia
State/province [304] 0 0
Johor
Country [305] 0 0
Malaysia
State/province [305] 0 0
Kelantan
Country [306] 0 0
Malaysia
State/province [306] 0 0
Kuala Lumpur
Country [307] 0 0
Malaysia
State/province [307] 0 0
Pahang
Country [308] 0 0
Malaysia
State/province [308] 0 0
Sarawak
Country [309] 0 0
Malaysia
State/province [309] 0 0
Selangor
Country [310] 0 0
Malaysia
State/province [310] 0 0
Wilayah Persekutuan Kuala Lumpur
Country [311] 0 0
Malaysia
State/province [311] 0 0
Alor Setar
Country [312] 0 0
Malaysia
State/province [312] 0 0
Kajang
Country [313] 0 0
Mexico
State/province [313] 0 0
Ags
Country [314] 0 0
Mexico
State/province [314] 0 0
Baja California
Country [315] 0 0
Mexico
State/province [315] 0 0
Jalisco
Country [316] 0 0
Mexico
State/province [316] 0 0
México, D.F.
Country [317] 0 0
Mexico
State/province [317] 0 0
NL
Country [318] 0 0
Mexico
State/province [318] 0 0
Nuevo Leon
Country [319] 0 0
Mexico
State/province [319] 0 0
Nuevo León
Country [320] 0 0
Mexico
State/province [320] 0 0
Querétaro
Country [321] 0 0
Mexico
State/province [321] 0 0
San Luis Potosi
Country [322] 0 0
Mexico
State/province [322] 0 0
Sinaloa
Country [323] 0 0
Mexico
State/province [323] 0 0
Veracruz
Country [324] 0 0
Mexico
State/province [324] 0 0
Mexico City
Country [325] 0 0
Mexico
State/province [325] 0 0
Mexico
Country [326] 0 0
Netherlands
State/province [326] 0 0
Amsterdam
Country [327] 0 0
Netherlands
State/province [327] 0 0
Den Haag
Country [328] 0 0
Netherlands
State/province [328] 0 0
Deventer
Country [329] 0 0
Netherlands
State/province [329] 0 0
Dordrecht
Country [330] 0 0
Netherlands
State/province [330] 0 0
Emmen
Country [331] 0 0
Netherlands
State/province [331] 0 0
Enschede
Country [332] 0 0
Netherlands
State/province [332] 0 0
Groningen
Country [333] 0 0
Netherlands
State/province [333] 0 0
Heerlen
Country [334] 0 0
Netherlands
State/province [334] 0 0
Maastricht
Country [335] 0 0
Netherlands
State/province [335] 0 0
Nijmegen
Country [336] 0 0
Netherlands
State/province [336] 0 0
Rotterdam
Country [337] 0 0
North Macedonia
State/province [337] 0 0
Skopje
Country [338] 0 0
Norway
State/province [338] 0 0
Bergen
Country [339] 0 0
Norway
State/province [339] 0 0
Lørenskog
Country [340] 0 0
Norway
State/province [340] 0 0
Oslo
Country [341] 0 0
Norway
State/province [341] 0 0
Stavanger
Country [342] 0 0
Poland
State/province [342] 0 0
Dolnoslaskie
Country [343] 0 0
Poland
State/province [343] 0 0
Kujawsko-pomorskie
Country [344] 0 0
Poland
State/province [344] 0 0
Kuyavian-Pomeranian Voivodeship
Country [345] 0 0
Poland
State/province [345] 0 0
Lodzkie
Country [346] 0 0
Poland
State/province [346] 0 0
Mazowieckie
Country [347] 0 0
Poland
State/province [347] 0 0
Malopolskie
Country [348] 0 0
Poland
State/province [348] 0 0
Podlaskie Voivodeship
Country [349] 0 0
Poland
State/province [349] 0 0
Podlaskie
Country [350] 0 0
Poland
State/province [350] 0 0
Silesian Voivodeship
Country [351] 0 0
Poland
State/province [351] 0 0
Slaskie
Country [352] 0 0
Poland
State/province [352] 0 0
Belchatow
Country [353] 0 0
Poland
State/province [353] 0 0
Gdynia
Country [354] 0 0
Poland
State/province [354] 0 0
Grodzisk Mazowiecki
Country [355] 0 0
Poland
State/province [355] 0 0
Krakow
Country [356] 0 0
Poland
State/province [356] 0 0
Lodz
Country [357] 0 0
Poland
State/province [357] 0 0
Przemysl
Country [358] 0 0
Poland
State/province [358] 0 0
Sztum
Country [359] 0 0
Poland
State/province [359] 0 0
Warszawa
Country [360] 0 0
Poland
State/province [360] 0 0
Lódz Voivodeship
Country [361] 0 0
Portugal
State/province [361] 0 0
Alcabideche
Country [362] 0 0
Portugal
State/province [362] 0 0
Braga
Country [363] 0 0
Portugal
State/province [363] 0 0
Guilhufe - Penafiel
Country [364] 0 0
Portugal
State/province [364] 0 0
Leiria
Country [365] 0 0
Portugal
State/province [365] 0 0
Lisboa
Country [366] 0 0
Portugal
State/province [366] 0 0
Lisbon
Country [367] 0 0
Portugal
State/province [367] 0 0
Porto
Country [368] 0 0
Portugal
State/province [368] 0 0
Santa Maria Da Feira
Country [369] 0 0
Portugal
State/province [369] 0 0
Setubal
Country [370] 0 0
Romania
State/province [370] 0 0
Targu Mures
Country [371] 0 0
Romania
State/province [371] 0 0
Baia Mare
Country [372] 0 0
Romania
State/province [372] 0 0
Braila
Country [373] 0 0
Romania
State/province [373] 0 0
Brasov
Country [374] 0 0
Romania
State/province [374] 0 0
Bucharest
Country [375] 0 0
Romania
State/province [375] 0 0
Bucuresti
Country [376] 0 0
Romania
State/province [376] 0 0
Buzau
Country [377] 0 0
Romania
State/province [377] 0 0
Constanta
Country [378] 0 0
Romania
State/province [378] 0 0
Craiova
Country [379] 0 0
Romania
State/province [379] 0 0
Galati
Country [380] 0 0
Romania
State/province [380] 0 0
Iasi
Country [381] 0 0
Romania
State/province [381] 0 0
Oradea
Country [382] 0 0
Romania
State/province [382] 0 0
Pascani
Country [383] 0 0
Romania
State/province [383] 0 0
Pitesti
Country [384] 0 0
Romania
State/province [384] 0 0
Timisoara
Country [385] 0 0
Romania
State/province [385] 0 0
Timi?oara
Country [386] 0 0
Serbia
State/province [386] 0 0
Belgrade
Country [387] 0 0
Serbia
State/province [387] 0 0
Kragujevac
Country [388] 0 0
Serbia
State/province [388] 0 0
Nis
Country [389] 0 0
Serbia
State/province [389] 0 0
Sremska Kamenica
Country [390] 0 0
Singapore
State/province [390] 0 0
Singapore
Country [391] 0 0
Slovakia
State/province [391] 0 0
Banskobystricky Kraj
Country [392] 0 0
Slovakia
State/province [392] 0 0
Presovsky Kraj
Country [393] 0 0
Slovakia
State/province [393] 0 0
Bratislava
Country [394] 0 0
Slovakia
State/province [394] 0 0
Kosice
Country [395] 0 0
Slovakia
State/province [395] 0 0
Nitra
Country [396] 0 0
Slovakia
State/province [396] 0 0
Trnava
Country [397] 0 0
Slovakia
State/province [397] 0 0
Zilina
Country [398] 0 0
Slovenia
State/province [398] 0 0
Celje
Country [399] 0 0
Slovenia
State/province [399] 0 0
Ljubljana
Country [400] 0 0
Slovenia
State/province [400] 0 0
Maribor
Country [401] 0 0
South Africa
State/province [401] 0 0
Eastern Cape
Country [402] 0 0
South Africa
State/province [402] 0 0
Free State
Country [403] 0 0
South Africa
State/province [403] 0 0
Gauteng
Country [404] 0 0
South Africa
State/province [404] 0 0
KwwaZulu Natal
Country [405] 0 0
South Africa
State/province [405] 0 0
Western Cape
Country [406] 0 0
Spain
State/province [406] 0 0
Barcelona
Country [407] 0 0
Spain
State/province [407] 0 0
Madrid
Country [408] 0 0
Spain
State/province [408] 0 0
Las Palmas de Gran Canaria
Country [409] 0 0
Spain
State/province [409] 0 0
Sevilla
Country [410] 0 0
Taiwan
State/province [410] 0 0
Kaohsiung city
Country [411] 0 0
Taiwan
State/province [411] 0 0
Taichung City
Country [412] 0 0
Taiwan
State/province [412] 0 0
Taipei city
Country [413] 0 0
Taiwan
State/province [413] 0 0
Taipei
Country [414] 0 0
Taiwan
State/province [414] 0 0
Taoyuan city
Country [415] 0 0
Thailand
State/province [415] 0 0
Pathumthani
Country [416] 0 0
Thailand
State/province [416] 0 0
Songkla
Country [417] 0 0
Thailand
State/province [417] 0 0
Bangkok
Country [418] 0 0
Thailand
State/province [418] 0 0
Chiang Mai
Country [419] 0 0
Thailand
State/province [419] 0 0
Chiang Rai
Country [420] 0 0
Thailand
State/province [420] 0 0
Khon Kaen
Country [421] 0 0
Thailand
State/province [421] 0 0
Nakhon Ratchasima
Country [422] 0 0
Thailand
State/province [422] 0 0
Phitsanulok
Country [423] 0 0
Thailand
State/province [423] 0 0
Samutsakhon
Country [424] 0 0
Thailand
State/province [424] 0 0
Ubon Ratchathani
Country [425] 0 0
Turkey
State/province [425] 0 0
Afyon
Country [426] 0 0
Turkey
State/province [426] 0 0
Ankara
Country [427] 0 0
Turkey
State/province [427] 0 0
Antalya
Country [428] 0 0
Turkey
State/province [428] 0 0
Edirne
Country [429] 0 0
Turkey
State/province [429] 0 0
Eskisehir
Country [430] 0 0
Turkey
State/province [430] 0 0
Istanbul
Country [431] 0 0
Turkey
State/province [431] 0 0
Izmir
Country [432] 0 0
Turkey
State/province [432] 0 0
Kayseri
Country [433] 0 0
Turkey
State/province [433] 0 0
Kocaeli
Country [434] 0 0
Turkey
State/province [434] 0 0
Mersin
Country [435] 0 0
United Kingdom
State/province [435] 0 0
Dorset
Country [436] 0 0
United Kingdom
State/province [436] 0 0
Essex
Country [437] 0 0
United Kingdom
State/province [437] 0 0
Lanarkshire
Country [438] 0 0
United Kingdom
State/province [438] 0 0
London
Country [439] 0 0
United Kingdom
State/province [439] 0 0
South Lanarkshire
Country [440] 0 0
United Kingdom
State/province [440] 0 0
West Sussex
Country [441] 0 0
United Kingdom
State/province [441] 0 0
Aberdeen
Country [442] 0 0
United Kingdom
State/province [442] 0 0
Bristol
Country [443] 0 0
United Kingdom
State/province [443] 0 0
Craigavon
Country [444] 0 0
United Kingdom
State/province [444] 0 0
Dorest
Country [445] 0 0
United Kingdom
State/province [445] 0 0
Exeter
Country [446] 0 0
United Kingdom
State/province [446] 0 0
Glasgow
Country [447] 0 0
United Kingdom
State/province [447] 0 0
High Wycombe
Country [448] 0 0
United Kingdom
State/province [448] 0 0
Liverpool
Country [449] 0 0
United Kingdom
State/province [449] 0 0
Manchester
Country [450] 0 0
United Kingdom
State/province [450] 0 0
North Shields
Country [451] 0 0
United Kingdom
State/province [451] 0 0
Oxford
Country [452] 0 0
United Kingdom
State/province [452] 0 0
Stockton-on-Tees

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
clinicaltrials@novonordisk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05636176