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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

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
Kidney disease
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/01/2026
Actual
Sample size
Target
6200
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
Gosford Renal Research - Gosford
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Westmead Applied Research Centre - Westmead
Recruitment hospital [6] 0 0
Illawarra Heart Health Centre - Wollongong
Recruitment hospital [7] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [8] 0 0
Core Research Centre - Milton
Recruitment hospital [9] 0 0
Nightingale Research - Adelaide
Recruitment hospital [10] 0 0
Royal Adelaide Hospital Cardiovascular Clinical Trials - Adelaide
Recruitment hospital [11] 0 0
HeartCare SA - Leabrook
Recruitment hospital [12] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [13] 0 0
Monash Health Heart - Clayton
Recruitment hospital [14] 0 0
St Vincent's Hospital_Fitzroy_0 - Fitzroy
Recruitment hospital [15] 0 0
Geelong Cardiology Research Unit - Geelong
Recruitment hospital [16] 0 0
Melbourne Renal Research Group - Reservoir
Recruitment hospital [17] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [18] 0 0
La Trobe Regional Hospital - Traralagon
Recruitment hospital [19] 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
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4575 - Birtinya
Recruitment postcode(s) [8] 0 0
4064 - Milton
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
5068 - Leabrook
Recruitment postcode(s) [11] 0 0
7000 - Hobart
Recruitment postcode(s) [12] 0 0
3168 - Clayton
Recruitment postcode(s) [13] 0 0
3065 - Fitzroy
Recruitment postcode(s) [14] 0 0
3220 - Geelong
Recruitment postcode(s) [15] 0 0
3073 - Reservoir
Recruitment postcode(s) [16] 0 0
3021 - St Albans
Recruitment postcode(s) [17] 0 0
3844 - Traralagon
Recruitment postcode(s) [18] 0 0
6027 - Joondalup
Recruitment outside Australia
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Aalborg
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Herning
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Viborg
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Germany
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Holstein
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Aachen
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Elsterwerda
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Essen
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Frankfurt
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Freiburg
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State/province [157] 0 0
Lübeck
Country [158] 0 0
Germany
State/province [158] 0 0
Mainz
Country [159] 0 0
Germany
State/province [159] 0 0
Mannheim
Country [160] 0 0
Germany
State/province [160] 0 0
Reichelsheim
Country [161] 0 0
Germany
State/province [161] 0 0
Witten
Country [162] 0 0
Greece
State/province [162] 0 0
Attica
Country [163] 0 0
Greece
State/province [163] 0 0
Alexandroupoli
Country [164] 0 0
Greece
State/province [164] 0 0
Athens
Country [165] 0 0
Greece
State/province [165] 0 0
Chios
Country [166] 0 0
Greece
State/province [166] 0 0
Heraklion
Country [167] 0 0
Greece
State/province [167] 0 0
Ioannina
Country [168] 0 0
Greece
State/province [168] 0 0
Kifissia
Country [169] 0 0
Greece
State/province [169] 0 0
Lamia
Country [170] 0 0
Greece
State/province [170] 0 0
Larissa
Country [171] 0 0
Greece
State/province [171] 0 0
Pylea, Thessaloniki
Country [172] 0 0
Greece
State/province [172] 0 0
Rio, Patra
Country [173] 0 0
Greece
State/province [173] 0 0
Thessaloniki
Country [174] 0 0
Hungary
State/province [174] 0 0
Békés Megye
Country [175] 0 0
Hungary
State/province [175] 0 0
Komárom-Esztergom
Country [176] 0 0
Hungary
State/province [176] 0 0
Zala Megye
Country [177] 0 0
Hungary
State/province [177] 0 0
Baja
Country [178] 0 0
Hungary
State/province [178] 0 0
Balatonfüred
Country [179] 0 0
Hungary
State/province [179] 0 0
Budapest
Country [180] 0 0
Hungary
State/province [180] 0 0
Debrecen
Country [181] 0 0
Hungary
State/province [181] 0 0
Szeged
Country [182] 0 0
India
State/province [182] 0 0
Andhra Pradesh
Country [183] 0 0
India
State/province [183] 0 0
Delhi
Country [184] 0 0
India
State/province [184] 0 0
Gujarat
Country [185] 0 0
India
State/province [185] 0 0
Karnataka
Country [186] 0 0
India
State/province [186] 0 0
Karnatka
Country [187] 0 0
India
State/province [187] 0 0
Kerala
Country [188] 0 0
India
State/province [188] 0 0
Maharashtra
Country [189] 0 0
India
State/province [189] 0 0
New Delhi
Country [190] 0 0
India
State/province [190] 0 0
Punjab
Country [191] 0 0
India
State/province [191] 0 0
Tamil Nadu
Country [192] 0 0
India
State/province [192] 0 0
Telangana
Country [193] 0 0
India
State/province [193] 0 0
Telengana
Country [194] 0 0
India
State/province [194] 0 0
Uttar Pradesh
Country [195] 0 0
India
State/province [195] 0 0
Chandigarh
Country [196] 0 0
India
State/province [196] 0 0
Jaipur
Country [197] 0 0
India
State/province [197] 0 0
Palakkad
Country [198] 0 0
Israel
State/province [198] 0 0
Holon
Country [199] 0 0
Israel
State/province [199] 0 0
Jerusalem
Country [200] 0 0
Israel
State/province [200] 0 0
Nahariya
Country [201] 0 0
Israel
State/province [201] 0 0
Petach Tikva
Country [202] 0 0
Israel
State/province [202] 0 0
Rehovot
Country [203] 0 0
Israel
State/province [203] 0 0
Tel Aviv
Country [204] 0 0
Israel
State/province [204] 0 0
Tel Hashomer
Country [205] 0 0
Italy
State/province [205] 0 0
Bg
Country [206] 0 0
Italy
State/province [206] 0 0
Cz
Country [207] 0 0
Italy
State/province [207] 0 0
Fe
Country [208] 0 0
Italy
State/province [208] 0 0
RM
Country [209] 0 0
Italy
State/province [209] 0 0
Arzignano (VI)
Country [210] 0 0
Italy
State/province [210] 0 0
Bologna
Country [211] 0 0
Italy
State/province [211] 0 0
Catania
Country [212] 0 0
Italy
State/province [212] 0 0
Chieti Scalo
Country [213] 0 0
Italy
State/province [213] 0 0
Firenze
Country [214] 0 0
Italy
State/province [214] 0 0
Genova
Country [215] 0 0
Italy
State/province [215] 0 0
Milano
Country [216] 0 0
Italy
State/province [216] 0 0
Milan
Country [217] 0 0
Italy
State/province [217] 0 0
Montichiari
Country [218] 0 0
Italy
State/province [218] 0 0
Napoli
Country [219] 0 0
Italy
State/province [219] 0 0
Palermo
Country [220] 0 0
Italy
State/province [220] 0 0
Pavia
Country [221] 0 0
Italy
State/province [221] 0 0
Pisa
Country [222] 0 0
Italy
State/province [222] 0 0
Roma
Country [223] 0 0
Italy
State/province [223] 0 0
Rome
Country [224] 0 0
Italy
State/province [224] 0 0
Trieste
Country [225] 0 0
Italy
State/province [225] 0 0
Verona
Country [226] 0 0
Japan
State/province [226] 0 0
Ehime
Country [227] 0 0
Japan
State/province [227] 0 0
Fukushima, Japan
Country [228] 0 0
Japan
State/province [228] 0 0
Kumamoto, Japan
Country [229] 0 0
Japan
State/province [229] 0 0
Miyazaki
Country [230] 0 0
Japan
State/province [230] 0 0
Bunkyo-ku, Tokyo
Country [231] 0 0
Japan
State/province [231] 0 0
Chiba-shi, Chiba
Country [232] 0 0
Japan
State/province [232] 0 0
Chikushino-shi, Fukuoka
Country [233] 0 0
Japan
State/province [233] 0 0
Chuo-city, Yamanashi
Country [234] 0 0
Japan
State/province [234] 0 0
Fukuoka-shi, Fukuoka
Country [235] 0 0
Japan
State/province [235] 0 0
Fukuoka-shi
Country [236] 0 0
Japan
State/province [236] 0 0
Hamada-shi, Shimane
Country [237] 0 0
Japan
State/province [237] 0 0
Hamamatsu-shi, Shizuoka
Country [238] 0 0
Japan
State/province [238] 0 0
Ibaraki,
Country [239] 0 0
Japan
State/province [239] 0 0
Ibaraki
Country [240] 0 0
Japan
State/province [240] 0 0
Kishiwada, Osaka
Country [241] 0 0
Japan
State/province [241] 0 0
Kita-azumi-gun, Nagano
Country [242] 0 0
Japan
State/province [242] 0 0
Kitakyushu-shi, Fukuoka
Country [243] 0 0
Japan
State/province [243] 0 0
Kitakyushu-shi,Fukuoka
Country [244] 0 0
Japan
State/province [244] 0 0
Koga-shi, Fukuoka
Country [245] 0 0
Japan
State/province [245] 0 0
Kumamoto-shi, Kumamoto
Country [246] 0 0
Japan
State/province [246] 0 0
Kure-shi, Hiroshima
Country [247] 0 0
Japan
State/province [247] 0 0
Kusegun, Kyoto
Country [248] 0 0
Japan
State/province [248] 0 0
Kyoto-shi, Kyoto
Country [249] 0 0
Japan
State/province [249] 0 0
Kyoto-shi,Kyoto
Country [250] 0 0
Japan
State/province [250] 0 0
Maebashi-shi, Gunma
Country [251] 0 0
Japan
State/province [251] 0 0
Matsubara-shi, Osaka
Country [252] 0 0
Japan
State/province [252] 0 0
Matsudo-shi
Country [253] 0 0
Japan
State/province [253] 0 0
Matsumoto-shi, Nagano
Country [254] 0 0
Japan
State/province [254] 0 0
Meguro-ku, Tokyo
Country [255] 0 0
Japan
State/province [255] 0 0
Minato-ku, Tokyo
Country [256] 0 0
Japan
State/province [256] 0 0
Miura-gun, Kanagawa
Country [257] 0 0
Japan
State/province [257] 0 0
Miyakonojo-shi, Miyazaki
Country [258] 0 0
Japan
State/province [258] 0 0
Morioka-shi, Iwate
Country [259] 0 0
Japan
State/province [259] 0 0
Nagoya-shi, Aichi
Country [260] 0 0
Japan
State/province [260] 0 0
Naha-shi, Okinawa
Country [261] 0 0
Japan
State/province [261] 0 0
Nara-shi, Nara
Country [262] 0 0
Japan
State/province [262] 0 0
Nishinomiya-shi, Hyogo
Country [263] 0 0
Japan
State/province [263] 0 0
Oita-shi, Oita
Country [264] 0 0
Japan
State/province [264] 0 0
Okayama
Country [265] 0 0
Japan
State/province [265] 0 0
Omihachiman-shi, Siga
Country [266] 0 0
Japan
State/province [266] 0 0
Osaka-city, Osaka
Country [267] 0 0
Japan
State/province [267] 0 0
Osaka-shi, Osaka
Country [268] 0 0
Japan
State/province [268] 0 0
Osaka-shi,Osaka
Country [269] 0 0
Japan
State/province [269] 0 0
Osaka
Country [270] 0 0
Japan
State/province [270] 0 0
Ota-shi, Gunma
Country [271] 0 0
Japan
State/province [271] 0 0
Sagamihara-shi, Kanagawa
Country [272] 0 0
Japan
State/province [272] 0 0
Saitama-shi, Saitama
Country [273] 0 0
Japan
State/province [273] 0 0
Sapporo-shi, Hokkaido
Country [274] 0 0
Japan
State/province [274] 0 0
Sendai-shi, Miyagi
Country [275] 0 0
Japan
State/province [275] 0 0
Suita-shi, Osaka
Country [276] 0 0
Japan
State/province [276] 0 0
Tachikawa-shi, Tokyo
Country [277] 0 0
Japan
State/province [277] 0 0
Takamatsu-shi, Kagawa
Country [278] 0 0
Japan
State/province [278] 0 0
Tokyo
Country [279] 0 0
Japan
State/province [279] 0 0
Tondabayashi-shi, Osaka
Country [280] 0 0
Japan
State/province [280] 0 0
Tsukuba-shi, Ibaraki
Country [281] 0 0
Japan
State/province [281] 0 0
Wakayama
Country [282] 0 0
Japan
State/province [282] 0 0
Wako-shi, Saitama
Country [283] 0 0
Japan
State/province [283] 0 0
Yokohama-shi, Kanagawa
Country [284] 0 0
Japan
State/province [284] 0 0
Yonezawa-shi, Yamagata
Country [285] 0 0
Korea, Republic of
State/province [285] 0 0
Busan
Country [286] 0 0
Korea, Republic of
State/province [286] 0 0
Daegu
Country [287] 0 0
Korea, Republic of
State/province [287] 0 0
Daejeon
Country [288] 0 0
Korea, Republic of
State/province [288] 0 0
Gangwon-do
Country [289] 0 0
Korea, Republic of
State/province [289] 0 0
Goyang
Country [290] 0 0
Korea, Republic of
State/province [290] 0 0
Gwangju
Country [291] 0 0
Korea, Republic of
State/province [291] 0 0
Gyeonggi-do
Country [292] 0 0
Korea, Republic of
State/province [292] 0 0
Gyeonggi-Do
Country [293] 0 0
Korea, Republic of
State/province [293] 0 0
Incheon
Country [294] 0 0
Korea, Republic of
State/province [294] 0 0
Seoul
Country [295] 0 0
Latvia
State/province [295] 0 0
Daugavpils
Country [296] 0 0
Latvia
State/province [296] 0 0
Jelgava
Country [297] 0 0
Latvia
State/province [297] 0 0
Riga
Country [298] 0 0
Lithuania
State/province [298] 0 0
Alytus
Country [299] 0 0
Lithuania
State/province [299] 0 0
Kaunas
Country [300] 0 0
Lithuania
State/province [300] 0 0
Klaipeda
Country [301] 0 0
Lithuania
State/province [301] 0 0
Panevezys
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
Kedah
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
Perak
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
Ipoh, Perak
Country [313] 0 0
Malaysia
State/province [313] 0 0
Pulau Pinang
Country [314] 0 0
Malaysia
State/province [314] 0 0
Sabah
Country [315] 0 0
Malaysia
State/province [315] 0 0
Seremban
Country [316] 0 0
Mexico
State/province [316] 0 0
Baja California
Country [317] 0 0
Mexico
State/province [317] 0 0
Jalisco
Country [318] 0 0
Mexico
State/province [318] 0 0
México, D.F.
Country [319] 0 0
Mexico
State/province [319] 0 0
Nuevo Leon
Country [320] 0 0
Mexico
State/province [320] 0 0
Nuevo León
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
Aguascalientes
Country [324] 0 0
Mexico
State/province [324] 0 0
Queretaro
Country [325] 0 0
Mexico
State/province [325] 0 0
Veracruz
Country [326] 0 0
Netherlands
State/province [326] 0 0
Alkmaar
Country [327] 0 0
Netherlands
State/province [327] 0 0
Almelo
Country [328] 0 0
Netherlands
State/province [328] 0 0
Amsterdam
Country [329] 0 0
Netherlands
State/province [329] 0 0
Apeldoorn
Country [330] 0 0
Netherlands
State/province [330] 0 0
Breda
Country [331] 0 0
Netherlands
State/province [331] 0 0
Harderwijk
Country [332] 0 0
Netherlands
State/province [332] 0 0
Hilversum
Country [333] 0 0
Netherlands
State/province [333] 0 0
Leiden
Country [334] 0 0
Netherlands
State/province [334] 0 0
Roosendaal
Country [335] 0 0
Netherlands
State/province [335] 0 0
Rotterdam
Country [336] 0 0
Netherlands
State/province [336] 0 0
Sneek
Country [337] 0 0
Netherlands
State/province [337] 0 0
Zaandam
Country [338] 0 0
Poland
State/province [338] 0 0
Dolnoslaskie
Country [339] 0 0
Poland
State/province [339] 0 0
Kujawsko-pomorskie
Country [340] 0 0
Poland
State/province [340] 0 0
Lodzkie
Country [341] 0 0
Poland
State/province [341] 0 0
Lubelskie
Country [342] 0 0
Poland
State/province [342] 0 0
Lublin Province
Country [343] 0 0
Poland
State/province [343] 0 0
Lubuskie
Country [344] 0 0
Poland
State/province [344] 0 0
Malopolskie
Country [345] 0 0
Poland
State/province [345] 0 0
Podlaskie
Country [346] 0 0
Poland
State/province [346] 0 0
Silesian Voivodeship
Country [347] 0 0
Poland
State/province [347] 0 0
Elblag
Country [348] 0 0
Poland
State/province [348] 0 0
Gdynia
Country [349] 0 0
Poland
State/province [349] 0 0
Grodzisk Mazowiecki
Country [350] 0 0
Poland
State/province [350] 0 0
Krakow
Country [351] 0 0
Poland
State/province [351] 0 0
Kraków
Country [352] 0 0
Poland
State/province [352] 0 0
Lodz
Country [353] 0 0
Poland
State/province [353] 0 0
Ogrodzieniec
Country [354] 0 0
Poland
State/province [354] 0 0
Poznan
Country [355] 0 0
Poland
State/province [355] 0 0
Pulawy
Country [356] 0 0
Poland
State/province [356] 0 0
Szczecin
Country [357] 0 0
Poland
State/province [357] 0 0
Tychy
Country [358] 0 0
Poland
State/province [358] 0 0
Warsaw
Country [359] 0 0
Poland
State/province [359] 0 0
Warszawa
Country [360] 0 0
Poland
State/province [360] 0 0
Wegrow
Country [361] 0 0
Poland
State/province [361] 0 0
Wroclaw
Country [362] 0 0
Poland
State/province [362] 0 0
Zamosc
Country [363] 0 0
Portugal
State/province [363] 0 0
Matosinhos
Country [364] 0 0
Portugal
State/province [364] 0 0
Almada
Country [365] 0 0
Portugal
State/province [365] 0 0
Aveiro
Country [366] 0 0
Portugal
State/province [366] 0 0
Braga
Country [367] 0 0
Portugal
State/province [367] 0 0
Carnaxide
Country [368] 0 0
Portugal
State/province [368] 0 0
Coimbra
Country [369] 0 0
Portugal
State/province [369] 0 0
Guilhufe - Penafiel
Country [370] 0 0
Portugal
State/province [370] 0 0
Lisboa
Country [371] 0 0
Portugal
State/province [371] 0 0
Lisbon
Country [372] 0 0
Portugal
State/province [372] 0 0
Porto
Country [373] 0 0
Portugal
State/province [373] 0 0
Setubal
Country [374] 0 0
Portugal
State/province [374] 0 0
Viana do Castelo
Country [375] 0 0
Portugal
State/province [375] 0 0
Vila Nova de Gaia
Country [376] 0 0
Romania
State/province [376] 0 0
Bucharest
Country [377] 0 0
Romania
State/province [377] 0 0
Bucurestii
Country [378] 0 0
Romania
State/province [378] 0 0
Cluj
Country [379] 0 0
Romania
State/province [379] 0 0
Baia Mare
Country [380] 0 0
Romania
State/province [380] 0 0
Braila
Country [381] 0 0
Romania
State/province [381] 0 0
Brasov
Country [382] 0 0
Romania
State/province [382] 0 0
Bucuresti
Country [383] 0 0
Romania
State/province [383] 0 0
Buzau
Country [384] 0 0
Romania
State/province [384] 0 0
Constanta
Country [385] 0 0
Romania
State/province [385] 0 0
Craiova
Country [386] 0 0
Romania
State/province [386] 0 0
Galati
Country [387] 0 0
Romania
State/province [387] 0 0
Iasi
Country [388] 0 0
Romania
State/province [388] 0 0
Oradea
Country [389] 0 0
Romania
State/province [389] 0 0
Pascani
Country [390] 0 0
Romania
State/province [390] 0 0
Pitesti
Country [391] 0 0
Romania
State/province [391] 0 0
Targu Mures
Country [392] 0 0
Romania
State/province [392] 0 0
Timisoara
Country [393] 0 0
Romania
State/province [393] 0 0
Tirgu Mures
Country [394] 0 0
Russian Federation
State/province [394] 0 0
Barnaul
Country [395] 0 0
Russian Federation
State/province [395] 0 0
Chelyabinsk
Country [396] 0 0
Russian Federation
State/province [396] 0 0
Chita
Country [397] 0 0
Russian Federation
State/province [397] 0 0
Irkutsk
Country [398] 0 0
Russian Federation
State/province [398] 0 0
Kazan
Country [399] 0 0
Russian Federation
State/province [399] 0 0
Kemerovo
Country [400] 0 0
Russian Federation
State/province [400] 0 0
Moscow
Country [401] 0 0
Russian Federation
State/province [401] 0 0
Novosibirsk
Country [402] 0 0
Russian Federation
State/province [402] 0 0
Perm
Country [403] 0 0
Russian Federation
State/province [403] 0 0
Petrozavodsk
Country [404] 0 0
Russian Federation
State/province [404] 0 0
Saint Petersburg
Country [405] 0 0
Russian Federation
State/province [405] 0 0
Saint-Petersburg
Country [406] 0 0
Russian Federation
State/province [406] 0 0
Samara
Country [407] 0 0
Russian Federation
State/province [407] 0 0
Sochi
Country [408] 0 0
Russian Federation
State/province [408] 0 0
Tomsk
Country [409] 0 0
Serbia
State/province [409] 0 0
Vojvodina
Country [410] 0 0
Serbia
State/province [410] 0 0
Belgrade
Country [411] 0 0
Serbia
State/province [411] 0 0
Kragujevac
Country [412] 0 0
Serbia
State/province [412] 0 0
Nis
Country [413] 0 0
Serbia
State/province [413] 0 0
Sremska Kamenica
Country [414] 0 0
Slovakia
State/province [414] 0 0
Bratislava
Country [415] 0 0
Slovakia
State/province [415] 0 0
Kosice
Country [416] 0 0
Slovakia
State/province [416] 0 0
Levice
Country [417] 0 0
Slovakia
State/province [417] 0 0
Lubochna
Country [418] 0 0
Slovakia
State/province [418] 0 0
Lucenec
Country [419] 0 0
Slovakia
State/province [419] 0 0
Martin
Country [420] 0 0
Slovakia
State/province [420] 0 0
Nitra
Country [421] 0 0
Slovakia
State/province [421] 0 0
Nove Zamky
Country [422] 0 0
Slovakia
State/province [422] 0 0
Piestany
Country [423] 0 0
Slovakia
State/province [423] 0 0
Povazska Bystrica
Country [424] 0 0
Slovakia
State/province [424] 0 0
Presov
Country [425] 0 0
South Africa
State/province [425] 0 0
Eastern Cape
Country [426] 0 0
South Africa
State/province [426] 0 0
Free State
Country [427] 0 0
South Africa
State/province [427] 0 0
Gauteng
Country [428] 0 0
South Africa
State/province [428] 0 0
KwaZulu-Natal
Country [429] 0 0
South Africa
State/province [429] 0 0
Western Cape
Country [430] 0 0
Spain
State/province [430] 0 0
Madrid
Country [431] 0 0
Spain
State/province [431] 0 0
Murcia
Country [432] 0 0
Spain
State/province [432] 0 0
Baracaldo
Country [433] 0 0
Spain
State/province [433] 0 0
Castilleja Dela Cuesta Sevilla
Country [434] 0 0
Spain
State/province [434] 0 0
Córdoba
Country [435] 0 0
Spain
State/province [435] 0 0
L' Hospitalet Del Llobregat
Country [436] 0 0
Spain
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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
[email protected]
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/NCT05021835