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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05021835




Registration number
NCT05021835
Ethics application status
Date submitted
19/08/2021
Date registered
26/08/2021
Date last updated
25/09/2025

Titles & IDs
Public title
ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation
Scientific title
ZEUS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation
Secondary ID [1] 0 0
U1111-1259-3422
Secondary ID [2] 0 0
EX6018-4758
Universal Trial Number (UTN)
Trial acronym
ZEUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Risk 0 0
Chronic Kidney Disease 0 0
Inflammation 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

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

Experimental: Ziltivekimab - Participants will receive Ziltivekimab B or Ziltivekimab C subcutaneously once monthly for up to 4 years.

Placebo comparator: Placebo - Participants will receive either placebo (Ziltivekimab B) or placebo (Ziltivekimab C) subcutaneously once monthly for up to 4 years.


Treatment: Drugs: Ziltivekimab B
Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.

Treatment: Drugs: Ziltivekimab C
Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.

Treatment: Drugs: Placebo (Ziltivekimab B)
Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.

Treatment: Drugs: Placebo (Ziltivekimab C)
Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of 3-point Major Adverse Cardiovascular Event (MACE), a composite endpoint consisting of: Cardiovascular (CV) death, non-fatal Myocardial Infarction (MI) and non-fatal stroke
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 expanded MACE, a composite endpoint consisting of: CV death, non-fatal MI, non-fatal stroke and hospitalisation for unstable angina pectoris requiring urgent coronary revascularisation
Timepoint [1] 0 0
From randomisation (month 0) to end-of-study (up to 48 months)
Secondary outcome [2] 0 0
Number of heart failure hospitalisations or urgent heart failure visits or CV deaths
Timepoint [2] 0 0
From randomisation (month 0) to end-of-study (up to 48 months)
Secondary outcome [3] 0 0
Time to first occurrence of a composite kidney endpoint consisting of: CV death, onset of persistent atleast 40 percent (%) reduction in eGFR (CKD-epidemiology collaboration [CKD-EPI]) compared with baseline, kidney failure
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 mortality
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 each of the individual components of the expanded MACE endpoint and the kidney composite endpoint.
Timepoint [5] 0 0
From randomisation (month 0) to end-of-study (up to 48 months).
Secondary outcome [6] 0 0
Time to first occurrence of MI (fatal and non-fatal).
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 stroke (fatal and non-fatal).
Timepoint [7] 0 0
From randomisation (month 0) to end-of-study (up to 48 months).
Secondary outcome [8] 0 0
Time to first occurrence of a composite MACE endpoint consisting of: all-cause mortality, non-fatal MI and non-fatal stroke
Timepoint [8] 0 0
From randomisation (month 0) to end-of-study (up to 48 months).
Secondary outcome [9] 0 0
Time to first occurrence of a 4-component kidney endpoint consisting of: onset of persistent at least 40% reduction in eGFR (CKD-EPI) compared with baseline, kidney failure
Timepoint [9] 0 0
From randomisation (month 0) to end-of-study (up to 48 months).
Secondary outcome [10] 0 0
Time to first occurrence of coronary revascularisation
Timepoint [10] 0 0
From randomisation (month 0) to end-of-study (up to 48 months).
Secondary outcome [11] 0 0
Change in Urinary Abumin-to-Ceatinine ratio (UACR).
Timepoint [11] 0 0
From randomisation (month 0) to 2 years (24 months).
Secondary outcome [12] 0 0
Change in eGFR (CKD-EPI))
Timepoint [12] 0 0
From randomisation (month 0) to 2 years (24 months)
Secondary outcome [13] 0 0
Annual rate of change in eGFR (CKD-EPI) (total eGFR slope)
Timepoint [13] 0 0
From randomisation (month 0) to end-of-study (up to 48 months).
Secondary outcome [14] 0 0
Change in high-sensitivity C-reactive protein (hs-CRP)
Timepoint [14] 0 0
From randomisation (month 0) to 2 years (24 months
Secondary outcome [15] 0 0
Change in N-terminal-pro-brain natriuretic peptide ( NT-pro-BNP)
Timepoint [15] 0 0
From randomisation (month 0) to 2 years (24 months)
Secondary outcome [16] 0 0
Change in left ventricular ejection fraction (LVEF)
Timepoint [16] 0 0
From randomisation (month 0) to 2 years (24 months)
Secondary outcome [17] 0 0
Number of events of atrial fibrillation
Timepoint [17] 0 0
From randomisation (month 0) to end-of-study (up to 48 months).
Secondary outcome [18] 0 0
Change in haemoglobin
Timepoint [18] 0 0
From randomisation (month 0) to 2 years (24 months)
Secondary outcome [19] 0 0
Number of hospitalisations with infection as primary cause or death due to infection.
Timepoint [19] 0 0
From randomisation (month 0) to end-of-study (up to 48 months).
Secondary outcome [20] 0 0
Change in Short Form 36 (SF-36) Physical Component Score (PCS)
Timepoint [20] 0 0
From randomisation (month 0) to 2 years (24 months)

Eligibility
Key inclusion criteria
* Chronic kidney disease defined by one of the below:

1. Estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 15 and below 60 mL/min/1.73 m^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
2. Urinary albumin-to-creatinine ratio (UACR) >= 200 milligrams per gram (mg/g) and eGFR >= 60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation)
* Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligram per liter (mg/L)
* Evidence of atherosclerotic cardiovascular disease (ASCVD) by one or more of the following:

a) Coronary heart disease defined as at least one of the following: i. Documented history of MI ii. Prior coronary revascularisation procedure iii. greater than or equal to 50% stenosis in major epicardial coronary artery documented by cardiac catheterisation or CT coronary angiography b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke of atherosclerotic origin ii. Prior carotid artery revascularisation procedure iii. greater than or equal to 50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound.

c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an ankle-brachial index (ABI) below or equal to 0.90 at rest ii. Intermittent claudication with a greater than or equal to 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound iii. Prior peripheral artery (excluding carotid) revascularisation procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris, or transient ischaemic attack within 60 days prior to randomisation (visit 2).
* Planned coronary, carotid or peripheral artery revascularisation known on the day of randomisation (visit 2).
* 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).

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital_Garran - Garran
Recruitment hospital [2] 0 0
Gosford Renal Research - Gosford
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Westmead Applied Research Centre - Westmead
Recruitment hospital [5] 0 0
Illawarra Heart Health Centre - Wollongong
Recruitment hospital [6] 0 0
Core Research Centre - Milton
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
HeartCare SA - Leabrook
Recruitment hospital [10] 0 0
Monash Health Heart - Clayton
Recruitment hospital [11] 0 0
St Vincent's Hospital_Fitzroy_0 - Fitzroy
Recruitment hospital [12] 0 0
Geelong Cardiology Research Unit - Geelong
Recruitment hospital [13] 0 0
Melbourne Renal Research Group - Reservoir
Recruitment hospital [14] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [15] 0 0
La Trobe Regional Hospital - Traralagon
Recruitment hospital [16] 0 0
HeartCare WA (Joondalup) - Joondalup
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4064 - Milton
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5068 - Leabrook
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3065 - Fitzroy
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
3073 - Reservoir
Recruitment postcode(s) [13] 0 0
3021 - St Albans
Recruitment postcode(s) [14] 0 0
3844 - Traralagon
Recruitment postcode(s) [15] 0 0
6027 - Joondalup
Recruitment outside Australia
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Dimitrovgrad
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Kyustendil
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Sliven
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Sofia
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Varna
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Yambol
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Tianjin Municipality
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China
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Zhejiang
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Shantou
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Shenyang
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Croatia
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City of Zagreb
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Rijeka
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Prague
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Aalborg
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Aarhus N
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Herning
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Hvidovre
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Kolding
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Roskilde
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Holstein
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Falkensee
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Frankfurt
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Homburg
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Jena
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Lübeck
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Germany
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Mainz
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Germany
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Reichelsheim
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Germany
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Witten
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Greece
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Attica
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Greece
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Alexandroupoli
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Athens
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Chios
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Heraklion
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Ioannina
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Kifissia
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Lamia
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Larissa
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Greece
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Rio, Patra
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Greece
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Thessaloniki
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Bekes County
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Komárom-Esztergom
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Zala County
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Baja
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Balatonfüred
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Budapest
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Debrecen
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Szeged
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India
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Andhra Pradesh
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Gujarat
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State/province [164] 0 0
Kerala
Country [165] 0 0
India
State/province [165] 0 0
Maharashtra
Country [166] 0 0
India
State/province [166] 0 0
National Capital Territory of Delhi
Country [167] 0 0
India
State/province [167] 0 0
New Delhi
Country [168] 0 0
India
State/province [168] 0 0
Punjab
Country [169] 0 0
India
State/province [169] 0 0
Telangana
Country [170] 0 0
India
State/province [170] 0 0
Uttar Pradesh
Country [171] 0 0
India
State/province [171] 0 0
Jaipur
Country [172] 0 0
India
State/province [172] 0 0
Palakkad
Country [173] 0 0
Israel
State/province [173] 0 0
Holon
Country [174] 0 0
Israel
State/province [174] 0 0
Jerusalem
Country [175] 0 0
Israel
State/province [175] 0 0
Nahariya
Country [176] 0 0
Israel
State/province [176] 0 0
Petah Tikva
Country [177] 0 0
Israel
State/province [177] 0 0
Rehovot
Country [178] 0 0
Israel
State/province [178] 0 0
Tel Aviv
Country [179] 0 0
Israel
State/province [179] 0 0
Tel Litwinsky
Country [180] 0 0
Italy
State/province [180] 0 0
Cz
Country [181] 0 0
Italy
State/province [181] 0 0
Fe
Country [182] 0 0
Italy
State/province [182] 0 0
Lombardy
Country [183] 0 0
Italy
State/province [183] 0 0
Bologna
Country [184] 0 0
Italy
State/province [184] 0 0
Chieti Scalo
Country [185] 0 0
Italy
State/province [185] 0 0
Florence
Country [186] 0 0
Italy
State/province [186] 0 0
Genova
Country [187] 0 0
Italy
State/province [187] 0 0
Milan
Country [188] 0 0
Italy
State/province [188] 0 0
Montichiari
Country [189] 0 0
Italy
State/province [189] 0 0
Napoli
Country [190] 0 0
Italy
State/province [190] 0 0
Palermo
Country [191] 0 0
Italy
State/province [191] 0 0
Pavia
Country [192] 0 0
Italy
State/province [192] 0 0
Pisa
Country [193] 0 0
Italy
State/province [193] 0 0
Roma
Country [194] 0 0
Italy
State/province [194] 0 0
Rome
Country [195] 0 0
Italy
State/province [195] 0 0
Trieste
Country [196] 0 0
Italy
State/province [196] 0 0
Verona
Country [197] 0 0
Japan
State/province [197] 0 0
Ehime
Country [198] 0 0
Japan
State/province [198] 0 0
Fukushima, Japan
Country [199] 0 0
Japan
State/province [199] 0 0
Kumamoto, Japan
Country [200] 0 0
Japan
State/province [200] 0 0
Miyazaki
Country [201] 0 0
Japan
State/province [201] 0 0
Bunkyo-ku, Tokyo
Country [202] 0 0
Japan
State/province [202] 0 0
Chiba-shi, Chiba
Country [203] 0 0
Japan
State/province [203] 0 0
Chikushino-shi, Fukuoka
Country [204] 0 0
Japan
State/province [204] 0 0
Chuo-city, Yamanashi
Country [205] 0 0
Japan
State/province [205] 0 0
Fukuoka
Country [206] 0 0
Japan
State/province [206] 0 0
Fukuoka-shi, Fukuoka
Country [207] 0 0
Japan
State/province [207] 0 0
Hamamatsu-shi, Shizuoka
Country [208] 0 0
Japan
State/province [208] 0 0
Ibaraki
Country [209] 0 0
Japan
State/province [209] 0 0
Kishiwada, Osaka
Country [210] 0 0
Japan
State/province [210] 0 0
Koga-shi, Fukuoka
Country [211] 0 0
Japan
State/province [211] 0 0
Kumamoto-shi, Kumamoto
Country [212] 0 0
Japan
State/province [212] 0 0
Kure-shi, Hiroshima
Country [213] 0 0
Japan
State/province [213] 0 0
Kusegun, Kyoto
Country [214] 0 0
Japan
State/province [214] 0 0
Kyoto-shi, Kyoto
Country [215] 0 0
Japan
State/province [215] 0 0
Kyoto-shi,Kyoto
Country [216] 0 0
Japan
State/province [216] 0 0
Maebashi-shi, Gunma
Country [217] 0 0
Japan
State/province [217] 0 0
Matsubara-shi, Osaka
Country [218] 0 0
Japan
State/province [218] 0 0
Matsudo-shi
Country [219] 0 0
Japan
State/province [219] 0 0
Matsumoto-shi, Nagano
Country [220] 0 0
Japan
State/province [220] 0 0
Meguro-ku, Tokyo
Country [221] 0 0
Japan
State/province [221] 0 0
Minato-ku, Tokyo
Country [222] 0 0
Japan
State/province [222] 0 0
Miura-gun, Kanagawa
Country [223] 0 0
Japan
State/province [223] 0 0
Miyakonojo-shi, Miyazaki
Country [224] 0 0
Japan
State/province [224] 0 0
Morioka-shi, Iwate
Country [225] 0 0
Japan
State/province [225] 0 0
Nagoya-shi, Aichi
Country [226] 0 0
Japan
State/province [226] 0 0
Naha-shi, Okinawa
Country [227] 0 0
Japan
State/province [227] 0 0
Nara-shi, Nara
Country [228] 0 0
Japan
State/province [228] 0 0
Nishinomiya-shi, Hyogo
Country [229] 0 0
Japan
State/province [229] 0 0
Oita-shi, Oita
Country [230] 0 0
Japan
State/province [230] 0 0
Okayama
Country [231] 0 0
Japan
State/province [231] 0 0
Omihachiman-shi, Siga
Country [232] 0 0
Japan
State/province [232] 0 0
Osaka
Country [233] 0 0
Japan
State/province [233] 0 0
Osaka-city, Osaka
Country [234] 0 0
Japan
State/province [234] 0 0
Osaka-shi, Osaka
Country [235] 0 0
Japan
State/province [235] 0 0
Osaka-shi,Osaka
Country [236] 0 0
Japan
State/province [236] 0 0
Ota-shi, Gunma
Country [237] 0 0
Japan
State/province [237] 0 0
Sagamihara-shi, Kanagawa
Country [238] 0 0
Japan
State/province [238] 0 0
Saitama-shi, Saitama
Country [239] 0 0
Japan
State/province [239] 0 0
Sapporo-shi, Hokkaido
Country [240] 0 0
Japan
State/province [240] 0 0
Sendai-shi, Miyagi
Country [241] 0 0
Japan
State/province [241] 0 0
Suita-shi, Osaka
Country [242] 0 0
Japan
State/province [242] 0 0
Takamatsu-shi, Kagawa
Country [243] 0 0
Japan
State/province [243] 0 0
Tokyo
Country [244] 0 0
Japan
State/province [244] 0 0
Tondabayashi-shi, Osaka
Country [245] 0 0
Japan
State/province [245] 0 0
Tsukuba-shi, Ibaraki
Country [246] 0 0
Japan
State/province [246] 0 0
Wakayama
Country [247] 0 0
Japan
State/province [247] 0 0
Wako-shi, Saitama
Country [248] 0 0
Japan
State/province [248] 0 0
Yokohama-shi, Kanagawa
Country [249] 0 0
Japan
State/province [249] 0 0
Yonezawa-shi, Yamagata
Country [250] 0 0
Latvia
State/province [250] 0 0
Daugavpils
Country [251] 0 0
Latvia
State/province [251] 0 0
Jelgava
Country [252] 0 0
Latvia
State/province [252] 0 0
Riga
Country [253] 0 0
Lithuania
State/province [253] 0 0
Alytus
Country [254] 0 0
Lithuania
State/province [254] 0 0
Kaunas
Country [255] 0 0
Lithuania
State/province [255] 0 0
Klaipeda
Country [256] 0 0
Lithuania
State/province [256] 0 0
Panevezys
Country [257] 0 0
Lithuania
State/province [257] 0 0
Å iauliai
Country [258] 0 0
Lithuania
State/province [258] 0 0
Vilnius
Country [259] 0 0
Malaysia
State/province [259] 0 0
Kedah
Country [260] 0 0
Malaysia
State/province [260] 0 0
Kelantan
Country [261] 0 0
Malaysia
State/province [261] 0 0
Kuala Lumpur
Country [262] 0 0
Malaysia
State/province [262] 0 0
Perak
Country [263] 0 0
Malaysia
State/province [263] 0 0
Sarawak
Country [264] 0 0
Malaysia
State/province [264] 0 0
Selangor
Country [265] 0 0
Malaysia
State/province [265] 0 0
Ipoh, Perak
Country [266] 0 0
Malaysia
State/province [266] 0 0
Pulau Pinang
Country [267] 0 0
Malaysia
State/province [267] 0 0
Sabak Bernam
Country [268] 0 0
Malaysia
State/province [268] 0 0
Seremban
Country [269] 0 0
Mexico
State/province [269] 0 0
Jalisco
Country [270] 0 0
Mexico
State/province [270] 0 0
México, D.F.
Country [271] 0 0
Mexico
State/province [271] 0 0
Nuevo León
Country [272] 0 0
Mexico
State/province [272] 0 0
San Luis Potosí
Country [273] 0 0
Mexico
State/province [273] 0 0
Sinaloa
Country [274] 0 0
Mexico
State/province [274] 0 0
Aguascalientes
Country [275] 0 0
Mexico
State/province [275] 0 0
Querétaro
Country [276] 0 0
Mexico
State/province [276] 0 0
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Country [277] 0 0
Netherlands
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Alkmaar
Country [278] 0 0
Netherlands
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Almelo
Country [279] 0 0
Netherlands
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Amsterdam
Country [280] 0 0
Netherlands
State/province [280] 0 0
Apeldoorn
Country [281] 0 0
Netherlands
State/province [281] 0 0
Breda
Country [282] 0 0
Netherlands
State/province [282] 0 0
Harderwijk
Country [283] 0 0
Netherlands
State/province [283] 0 0
Hilversum
Country [284] 0 0
Netherlands
State/province [284] 0 0
Roosendaal
Country [285] 0 0
Netherlands
State/province [285] 0 0
Rotterdam
Country [286] 0 0
Netherlands
State/province [286] 0 0
Sneek
Country [287] 0 0
Netherlands
State/province [287] 0 0
Zaandam
Country [288] 0 0
Poland
State/province [288] 0 0
Kuyavian-Pomeranian Voivodeship
Country [289] 0 0
Poland
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Lesser Poland Voivodeship
Country [290] 0 0
Poland
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Lower Silesian Voivodeship
Country [291] 0 0
Poland
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Lublin Voivodeship
Country [292] 0 0
Poland
State/province [292] 0 0
Lubusz Voivodeship
Country [293] 0 0
Poland
State/province [293] 0 0
Podlaskie Voivodeship
Country [294] 0 0
Poland
State/province [294] 0 0
Pomeranian Voivodeship
Country [295] 0 0
Poland
State/province [295] 0 0
Silesian Voivodeship
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Poland
State/province [296] 0 0
Elblag
Country [297] 0 0
Poland
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Grodzisk Mazowiecki
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Poznan
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Poland
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Pulawy
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Poland
State/province [302] 0 0
Szczecin
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Poland
State/province [303] 0 0
Tychy
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Poland
State/province [304] 0 0
Warsaw
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Poland
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Poland
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Wroclaw
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Poland
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Zamosc
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Poland
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Lódz Voivodeship
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Portugal
State/province [309] 0 0
Lisbon District
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Portugal
State/province [310] 0 0
Matosinhos
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Portugal
State/province [311] 0 0
Almada
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Portugal
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Aveiro
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Portugal
State/province [313] 0 0
Braga
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Portugal
State/province [314] 0 0
Coimbra
Country [315] 0 0
Portugal
State/province [315] 0 0
Guilhufe - Penafiel
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Portugal
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Lisbon
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Portugal
State/province [317] 0 0
Porto
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Portugal
State/province [318] 0 0
Setúbal
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Portugal
State/province [319] 0 0
Viana do Castelo
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Portugal
State/province [320] 0 0
Vila Nova de Gaia
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Romania
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Cluj
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Romania
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Baia Mare
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Romania
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Brasov
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Romania
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Braila
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Romania
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Bucharest
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Romania
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Romania
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Constan?a
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Romania
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Craiova
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Romania
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Galati
Country [330] 0 0
Romania
State/province [330] 0 0
Ia?i
Country [331] 0 0
Romania
State/province [331] 0 0
Oradea
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Romania
State/province [332] 0 0
Pascani
Country [333] 0 0
Romania
State/province [333] 0 0
Pitesti
Country [334] 0 0
Romania
State/province [334] 0 0
Târgu Mures
Country [335] 0 0
Romania
State/province [335] 0 0
Timi?oara
Country [336] 0 0
Russia
State/province [336] 0 0
Barnaul
Country [337] 0 0
Russia
State/province [337] 0 0
Chelyabinsk
Country [338] 0 0
Russia
State/province [338] 0 0
Irkutsk
Country [339] 0 0
Russia
State/province [339] 0 0
Kazan'
Country [340] 0 0
Russia
State/province [340] 0 0
Moscow
Country [341] 0 0
Russia
State/province [341] 0 0
Novosibirsk
Country [342] 0 0
Russia
State/province [342] 0 0
Sochi
Country [343] 0 0
Russia
State/province [343] 0 0
Tomsk
Country [344] 0 0
Serbia
State/province [344] 0 0
Vojvodina
Country [345] 0 0
Serbia
State/province [345] 0 0
Belgrade
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Serbia
State/province [346] 0 0
Kamenitz
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Serbia
State/province [347] 0 0
Kragujevac
Country [348] 0 0
Serbia
State/province [348] 0 0
Niš
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Serbia
State/province [349] 0 0
Novi Sad
Country [350] 0 0
Slovakia
State/province [350] 0 0
Bratislava
Country [351] 0 0
Slovakia
State/province [351] 0 0
Košice
Country [352] 0 0
Slovakia
State/province [352] 0 0
Levice
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Slovakia
State/province [353] 0 0
Lucenec
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Slovakia
State/province [354] 0 0
Lubochna
Country [355] 0 0
Slovakia
State/province [355] 0 0
Martin
Country [356] 0 0
Slovakia
State/province [356] 0 0
Nitra
Country [357] 0 0
Slovakia
State/province [357] 0 0
Nové Zámky
Country [358] 0 0
Slovakia
State/province [358] 0 0
Pieštany
Country [359] 0 0
Slovakia
State/province [359] 0 0
Prešov
Country [360] 0 0
South Africa
State/province [360] 0 0
Free State
Country [361] 0 0
South Africa
State/province [361] 0 0
Gauteng
Country [362] 0 0
South Africa
State/province [362] 0 0
KwaZulu-Natal
Country [363] 0 0
South Africa
State/province [363] 0 0
Western Cape
Country [364] 0 0
South Korea
State/province [364] 0 0
Busan
Country [365] 0 0
South Korea
State/province [365] 0 0
Daegu
Country [366] 0 0
South Korea
State/province [366] 0 0
Daejeon
Country [367] 0 0
South Korea
State/province [367] 0 0
Gangwon-do
Country [368] 0 0
South Korea
State/province [368] 0 0
Goyang
Country [369] 0 0
South Korea
State/province [369] 0 0
Gwangju
Country [370] 0 0
South Korea
State/province [370] 0 0
Gyeonggi-do
Country [371] 0 0
South Korea
State/province [371] 0 0
Incheon
Country [372] 0 0
South Korea
State/province [372] 0 0
Seoul
Country [373] 0 0
Spain
State/province [373] 0 0
Madrid
Country [374] 0 0
Spain
State/province [374] 0 0
Murcia
Country [375] 0 0
Spain
State/province [375] 0 0
Barakaldo
Country [376] 0 0
Spain
State/province [376] 0 0
Córdoba
Country [377] 0 0
Spain
State/province [377] 0 0
L' Hospitalet Del Llobregat
Country [378] 0 0
Spain
State/province [378] 0 0
Sanlúcar de Barrameda
Country [379] 0 0
Spain
State/province [379] 0 0
Seville
Country [380] 0 0
Spain
State/province [380] 0 0
Valencia
Country [381] 0 0
Spain
State/province [381] 0 0
Villamartín
Country [382] 0 0
Spain
State/province [382] 0 0
Zaragoza
Country [383] 0 0
Sweden
State/province [383] 0 0
Stockholm County
Country [384] 0 0
Sweden
State/province [384] 0 0
Gothenburg
Country [385] 0 0
Sweden
State/province [385] 0 0
Lund
Country [386] 0 0
Sweden
State/province [386] 0 0
Malmo
Country [387] 0 0
Sweden
State/province [387] 0 0
Stockholm
Country [388] 0 0
Sweden
State/province [388] 0 0
Uppsala
Country [389] 0 0
Taiwan
State/province [389] 0 0
Hsinchu
Country [390] 0 0
Taiwan
State/province [390] 0 0
Kaohsiung City
Country [391] 0 0
Taiwan
State/province [391] 0 0
Tainan City
Country [392] 0 0
Taiwan
State/province [392] 0 0
Taipei
Country [393] 0 0
Taiwan
State/province [393] 0 0
Taoyuan District
Country [394] 0 0
Taiwan
State/province [394] 0 0
Yilan
Country [395] 0 0
Thailand
State/province [395] 0 0
Bangkok
Country [396] 0 0
Thailand
State/province [396] 0 0
Changwat Pathum Thani
Country [397] 0 0
Thailand
State/province [397] 0 0
Changwat Songkhla
Country [398] 0 0
Thailand
State/province [398] 0 0
Mueang Chiang Mai
Country [399] 0 0
Thailand
State/province [399] 0 0
Patumwan
Country [400] 0 0
Thailand
State/province [400] 0 0
Rajathewee
Country [401] 0 0
Thailand
State/province [401] 0 0
Thung Phayathai Subdistrict
Country [402] 0 0
Thailand
State/province [402] 0 0
Chiang Mai
Country [403] 0 0
Thailand
State/province [403] 0 0
Khon Kaen
Country [404] 0 0
Thailand
State/province [404] 0 0
Nakhon Ratchasima
Country [405] 0 0
Thailand
State/province [405] 0 0
Pathum Thani
Country [406] 0 0
Thailand
State/province [406] 0 0
Songkhla
Country [407] 0 0
Thailand
State/province [407] 0 0
Ubon Ratchathani
Country [408] 0 0
Turkey (Türkiye)
State/province [408] 0 0
Bakirkoy
Country [409] 0 0
Turkey (Türkiye)
State/province [409] 0 0
Afyonkarahisar
Country [410] 0 0
Turkey (Türkiye)
State/province [410] 0 0
Ankara
Country [411] 0 0
Turkey (Türkiye)
State/province [411] 0 0
Antalya
Country [412] 0 0
Turkey (Türkiye)
State/province [412] 0 0
Aydin
Country [413] 0 0
Turkey (Türkiye)
State/province [413] 0 0
Edirne
Country [414] 0 0
Turkey (Türkiye)
State/province [414] 0 0
Eskisehir
Country [415] 0 0
Turkey (Türkiye)
State/province [415] 0 0
Istanbul
Country [416] 0 0
Turkey (Türkiye)
State/province [416] 0 0
Izmir
Country [417] 0 0
Turkey (Türkiye)
State/province [417] 0 0
Kahramanmaras
Country [418] 0 0
Turkey (Türkiye)
State/province [418] 0 0
Kayseri
Country [419] 0 0
Turkey (Türkiye)
State/province [419] 0 0
Kocaeli
Country [420] 0 0
Turkey (Türkiye)
State/province [420] 0 0
Mugla
Country [421] 0 0
Ukraine
State/province [421] 0 0
Chernivtsi
Country [422] 0 0
Ukraine
State/province [422] 0 0
Kharkiv
Country [423] 0 0
Ukraine
State/province [423] 0 0
Kyiv
Country [424] 0 0
United Kingdom
State/province [424] 0 0
Cheshire
Country [425] 0 0
United Kingdom
State/province [425] 0 0
Dorset
Country [426] 0 0
United Kingdom
State/province [426] 0 0
Lancashire
Country [427] 0 0
United Kingdom
State/province [427] 0 0
North Yorkshire
Country [428] 0 0
United Kingdom
State/province [428] 0 0
Northamptonshire
Country [429] 0 0
United Kingdom
State/province [429] 0 0
Surrey
Country [430] 0 0
United Kingdom
State/province [430] 0 0
West Sussex
Country [431] 0 0
United Kingdom
State/province [431] 0 0
Barnet
Country [432] 0 0
United Kingdom
State/province [432] 0 0
Bradford
Country [433] 0 0
United Kingdom
State/province [433] 0 0
Bradford-on-Avon
Country [434] 0 0
United Kingdom
State/province [434] 0 0
Bristol
Country [435] 0 0
United Kingdom
State/province [435] 0 0
Cambridge
Country [436] 0 0
United Kingdom
State/province [436] 0 0
Exeter
Country [437] 0 0
United Kingdom
State/province [437] 0 0
High Wycombe
Country [438] 0 0
United Kingdom
State/province [438] 0 0
Leicester
Country [439] 0 0
United Kingdom
State/province [439] 0 0
Lincoln
Country [440] 0 0
United Kingdom
State/province [440] 0 0
Liverpool
Country [441] 0 0
United Kingdom
State/province [441] 0 0
London
Country [442] 0 0
United Kingdom
State/province [442] 0 0
Newcastle upon Tyne
Country [443] 0 0
United Kingdom
State/province [443] 0 0
Oxford
Country [444] 0 0
United Kingdom
State/province [444] 0 0
Preston
Country [445] 0 0
United Kingdom
State/province [445] 0 0
Stevenage
Country [446] 0 0
United Kingdom
State/province [446] 0 0
Stockton-on-Tees
Country [447] 0 0
United Kingdom
State/province [447] 0 0
Torquay
Country [448] 0 0
United Kingdom
State/province [448] 0 0
Wellingborough

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
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.