ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05021835
Collaborator
(none)
6,200
486
2
49.5
12.8
0.3

Study Details

Study Description

Brief Summary

This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation.

Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same.

Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe.

Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly.

The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits.

Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram).

Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
ZEUS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation
Actual Study Start Date :
Aug 30, 2021
Anticipated Primary Completion Date :
Sep 24, 2025
Anticipated Study Completion Date :
Oct 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: ziltivekimab 15 mg

Participants will receive ziltivekimab 15 mg for up to 4 years.

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

Placebo Comparator: Placebo (ziltivekimab)

Participants will receive placebo (ziltivekimab) for up to 4 years.

Drug: Placebo (ziltivekimab)
Administered subcutaneously (s.c., under skin) once-monthly and added to standard of care

Outcome Measures

Primary Outcome Measures

  1. 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. [From randomisation (month 0) to end-of-study (up to 48 months)]

    Months

Secondary Outcome Measures

  1. Time to first occurrence of 3-point MACE, a composite endpoint consisting of: CV death, non-fatal MI, non-fatal stroke and hospitalisation for unstable angina pectoris requiring urgent coronary revascularisation [From randomisation (month 0) to end-of-study (up to 48 months)]

    Months

  2. Number of hospitalisations for heart failure or urgent heart failure visit. [From randomisation (month 0) to end-of-study (up to 48 months)]

    Count

  3. Time to occurrence of all-cause mortality. [From randomisation (month 0) to end-of-study (up to 48 months)]

    Months

  4. Time to first occ. of composite Chronic Kidney Disease (CKD) endpoint consisting of onset of persistent at least 40% reduction in estimated glomerular filtration rate (eGFR) CKD-Epidemiology Collaboration (CKD-EPI) compared with baseline, kidney failure [From randomisation (month 0) to end-of-study (up to 48 months)]

    Months

  5. Time to first occurrence of each of the individual components of the expanded MACE endpoint and the kidney composite endpoint. [From randomisation (month 0) to end-of-study (up to 48 months).]

    Months

  6. Time to first occurrence of MI (fatal and non-fatal). [From randomisation (month 0) to end-of-study (up to 48 months).]

    Months

  7. Time to first occurrence of stroke (fatal and non-fatal). [From randomisation (month 0) to end-of-study (up to 48 months).]

    Months

  8. Time to first occurrence of a composite MACE endpoint consisting of: all-cause mortality, non-fatal MI and non-fatal stroke. [From randomisation (month 0) to end-of-study (up to 48 months).]

    Months

  9. Time to first occurrence of an expanded composite kidney endpoint consisting of: CV death, onset of persistent at least 40% reduction in eGFR (CKD-EPI) compared with baseline, kidney failure. [From randomisation (month 0) to end-of-study (up to 48 months).]

    Months

  10. Time to first occurrence of coronary revascularisation [From randomisation (month 0) to end-of-study (up to 48 months).]

    Months

  11. Change in Urinary Abumin-to-Ceatinine ratio (UACR). [From randomisation (month 0) to 2 years (24 months).]

    Percentage

  12. Change in eGFR (CKD-EPI)) [From randomisation (month 0) to 2 years (24 months)]

    mL/min/1.73 m^2

  13. Annual rate of change in eGFR (CKD-EPI) (total eGFR slope) [From randomisation (month 0) to end-of-study (up to 48 months).]

    mL/min/1.73 m^2/ year

  14. Change in high-sensitivity C-reactive protein (hs-CRP) [From randomisation (month 0) to 2 years (24 months]

    Percentage

  15. Change in N-terminal-pro-brain natriuretic peptide ( NT-pro-BNP) [From randomisation (month 0) to 2 years (24 months)]

    Percentage

  16. Change in left ventricular ejection fraction (LVEF) [From randomisation (month 0) to 2 years (24 months)]

    Percentage

  17. Number of events of atrial fibrillation [From randomisation (month 0) to end-of-study (up to 48 months).]

    Count

  18. Number of hospitalisations with infection as primary cause or death due to infection. [From randomisation (month 0) to end-of-study (up to 48 months).]

    Count

  19. Change in Short Form 36 (SF-36) Physical Component Score (PCS) [From randomisation (month 0) to 2 years (24 months)]

    Score on scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Estimated glomerular filtration rate (eGFR) 15 and below 60 mL/min/1.73 m^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)

  • Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 mg/L at screening (visit 1)

  • Evidence of atherosclerotic cardiovascular disease (ASCVD) by one or more of the following:

  1. 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.

  2. 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).

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 screening (visit 1).

  • Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit

  1. or any major surgical procedure planned at the time of randomisation (visit 2).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Birmingham Alabama United States 35294
2 Novo Nordisk Investigational Site Montgomery Alabama United States 36106
3 Novo Nordisk Investigational Site Glendale Arizona United States 85308
4 Novo Nordisk Investigational Site Mesa Arizona United States 85210
5 Novo Nordisk Investigational Site Searcy Arkansas United States 72143
6 Novo Nordisk Investigational Site Covina California United States 91723
7 Novo Nordisk Investigational Site La Jolla California United States 92037
8 Novo Nordisk Investigational Site La Mesa California United States 91942
9 Novo Nordisk Investigational Site Lancaster California United States 93534
10 Novo Nordisk Investigational Site Loma Linda California United States 92357
11 Novo Nordisk Investigational Site Los Alamitos California United States 90720
12 Novo Nordisk Investigational Site Los Angeles California United States 90010
13 Novo Nordisk Investigational Site Lynwood California United States 90262
14 Novo Nordisk Investigational Site Northridge California United States 91325
15 Novo Nordisk Investigational Site Palm Springs California United States 92262
16 Novo Nordisk Investigational Site Riverside California United States 92503
17 Novo Nordisk Investigational Site S. Gate California United States 90280
18 Novo Nordisk Investigational Site San Dimas California United States 91773
19 Novo Nordisk Investigational Site Torrance California United States 90502
20 Novo Nordisk Investigational Site Bridgeport Connecticut United States 06610
21 Novo Nordisk Investigational Site West Haven Connecticut United States 06516
22 Novo Nordisk Investigational Site Boca Raton Florida United States 33434
23 Novo Nordisk Investigational Site Boynton Beach Florida United States 33437
24 Novo Nordisk Investigational Site Clearwater Florida United States 33756
25 Novo Nordisk Investigational Site Fleming Island Florida United States 32003
26 Novo Nordisk Investigational Site Fort Lauderdale Florida United States 33312
27 Novo Nordisk Investigational Site Hollywood Florida United States 33021
28 Novo Nordisk Investigational Site Hollywood Florida United States 33024
29 Novo Nordisk Investigational Site Jacksonville Florida United States 32204
30 Novo Nordisk Investigational Site Jacksonville Florida United States 32216
31 Novo Nordisk Investigational Site Jacksonville Florida United States 32258
32 Novo Nordisk Investigational Site Miami Lakes Florida United States 33014
33 Novo Nordisk Investigational Site Miami Florida United States 33126
34 Novo Nordisk Investigational Site Miami Florida United States 33130
35 Novo Nordisk Investigational Site Miami Florida United States 33155
36 Novo Nordisk Investigational Site New Port Richey Florida United States 34652
37 Novo Nordisk Investigational Site Palm Harbor Florida United States 34684
38 Novo Nordisk Investigational Site Pembroke Pines Florida United States 33024
39 Novo Nordisk Investigational Site Pembroke Pines Florida United States 33027
40 Novo Nordisk Investigational Site Port Charlotte Florida United States 33952
41 Novo Nordisk Investigational Site Port Charlotte Florida United States 33952
42 Novo Nordisk Investigational Site Saint Augustine Florida United States 32080
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44 Novo Nordisk Investigational Site Winter Haven Florida United States 33880
45 Novo Nordisk Investigational Site Albany Georgia United States 31707
46 Novo Nordisk Investigational Site Augusta Georgia United States 30904
47 Novo Nordisk Investigational Site Conyers Georgia United States 30094
48 Novo Nordisk Investigational Site Fayetteville Georgia United States 30214
49 Novo Nordisk Investigational Site Johns Creek Georgia United States 30024
50 Novo Nordisk Investigational Site Roswell Georgia United States 30076
51 Novo Nordisk Investigational Site Savannah Georgia United States 31406
52 Novo Nordisk Investigational Site Nampa Idaho United States 83686-6011
53 Novo Nordisk Investigational Site Arlington Heights Illinois United States 60005
54 Novo Nordisk Investigational Site Chicago Illinois United States 60643
55 Novo Nordisk Investigational Site Gurnee Illinois United States 60031
56 Novo Nordisk Investigational Site Hazel Crest Illinois United States 60429
57 Novo Nordisk Investigational Site Skokie Illinois United States 60077
58 Novo Nordisk Investigational Site Springfield Illinois United States 62711
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60 Novo Nordisk Investigational Site Evansville Indiana United States 47714
61 Novo Nordisk Investigational Site Valparaiso Indiana United States 46383
62 Novo Nordisk Investigational Site Overland Park Kansas United States 66211
63 Novo Nordisk Investigational Site Topeka Kansas United States 66606
64 Novo Nordisk Investigational Site Lexington Kentucky United States 40502
65 Novo Nordisk Investigational Site Lexington Kentucky United States 40503
66 Novo Nordisk Investigational Site Louisville Kentucky United States 40205
67 Novo Nordisk Investigational Site Bossier City Louisiana United States 71111
68 Novo Nordisk Investigational Site Monroe Louisiana United States 71201
69 Novo Nordisk Investigational Site Shreveport Louisiana United States 71105
70 Novo Nordisk Investigational Site Slidell Louisiana United States 70458
71 Novo Nordisk Investigational Site West Monroe Louisiana United States 71291
72 Novo Nordisk Investigational Site Annapolis Maryland United States 21401
73 Novo Nordisk Investigational Site Bethesda Maryland United States 20814
74 Novo Nordisk Investigational Site Camp Springs Maryland United States 20746
75 Novo Nordisk Investigational Site Boston Massachusetts United States 02115-5804
76 Novo Nordisk Investigational Site Haverhill Massachusetts United States 01830
77 Novo Nordisk Investigational Site Detroit Michigan United States 48202
78 Novo Nordisk Investigational Site Flint Michigan United States 48532
79 Novo Nordisk Investigational Site Grand Rapids Michigan United States 49546
80 Novo Nordisk Investigational Site Petoskey Michigan United States 49770
81 Novo Nordisk Investigational Site Minneapolis Minnesota United States 55407
82 Novo Nordisk Investigational Site Minneapolis Minnesota United States 55455
83 Novo Nordisk Investigational Site Kansas City Missouri United States 64111
84 Novo Nordisk Investigational Site Saint Louis Missouri United States 63128
85 Novo Nordisk Investigational Site Saint Louis Missouri United States 63136
86 Novo Nordisk Investigational Site Lincoln Nebraska United States 68526
87 Novo Nordisk Investigational Site Omaha Nebraska United States 68105
88 Novo Nordisk Investigational Site Omaha Nebraska United States 68114
89 Novo Nordisk Investigational Site Omaha Nebraska United States 68198-3020
90 Novo Nordisk Investigational Site Las Vegas Nevada United States 89128
91 Novo Nordisk Investigational Site Bridgewater New Jersey United States 08807-3064
92 Novo Nordisk Investigational Site Albuquerque New Mexico United States 87106
93 Novo Nordisk Investigational Site Northport New York United States 11768
94 Novo Nordisk Investigational Site Ridgewood New York United States 11385
95 Novo Nordisk Investigational Site Saratoga Springs New York United States 12866
96 Novo Nordisk Investigational Site West Seneca New York United States 14224
97 Novo Nordisk Investigational Site Westfield New York United States 14787
98 Novo Nordisk Investigational Site Asheville North Carolina United States 28801
99 Novo Nordisk Investigational Site Burlington North Carolina United States 27215
100 Novo Nordisk Investigational Site Chapel Hill North Carolina United States 27599
101 Novo Nordisk Investigational Site Charlotte North Carolina United States 28207
102 Novo Nordisk Investigational Site Charlotte North Carolina United States 28210
103 Novo Nordisk Investigational Site Greensboro North Carolina United States 27408
104 Novo Nordisk Investigational Site Greenville North Carolina United States 27834
105 Novo Nordisk Investigational Site Morehead City North Carolina United States 28557-4346
106 Novo Nordisk Investigational Site Fargo North Dakota United States 58104
107 Novo Nordisk Investigational Site Cleveland Ohio United States 44106
108 Novo Nordisk Investigational Site Maumee Ohio United States 43537
109 Novo Nordisk Investigational Site Bethlehem Pennsylvania United States 18017
110 Novo Nordisk Investigational Site Philadelphia Pennsylvania United States 19114
111 Novo Nordisk Investigational Site Philadelphia Pennsylvania United States 19144
112 Novo Nordisk Investigational Site Lincoln Rhode Island United States 02865
113 Novo Nordisk Investigational Site Fort Mill South Carolina United States 29707
114 Novo Nordisk Investigational Site Greenville South Carolina United States 29615
115 Novo Nordisk Investigational Site Myrtle Beach South Carolina United States 29588
116 Novo Nordisk Investigational Site Spartanburg South Carolina United States 29303
117 Novo Nordisk Investigational Site Chattanooga Tennessee United States 37411
118 Novo Nordisk Investigational Site Greeneville Tennessee United States 37745
119 Novo Nordisk Investigational Site Knoxville Tennessee United States 37934
120 Novo Nordisk Investigational Site Memphis Tennessee United States 38119
121 Novo Nordisk Investigational Site Powell Tennessee United States 37849
122 Novo Nordisk Investigational Site Arlington Texas United States 76012-4637
123 Novo Nordisk Investigational Site Corpus Christi Texas United States 78414
124 Novo Nordisk Investigational Site Dallas Texas United States 75208
125 Novo Nordisk Investigational Site Dallas Texas United States 75230
126 Novo Nordisk Investigational Site Dallas Texas United States 75235
127 Novo Nordisk Investigational Site Edinburg Texas United States 78539
128 Novo Nordisk Investigational Site El Paso Texas United States 79935
129 Novo Nordisk Investigational Site Forney Texas United States 75126
130 Novo Nordisk Investigational Site Fort Worth Texas United States 76132
131 Novo Nordisk Investigational Site Fort Worth Texas United States 76133
132 Novo Nordisk Investigational Site Houston Texas United States 77024
133 Novo Nordisk Investigational Site Houston Texas United States 77030
134 Novo Nordisk Investigational Site Houston Texas United States 77043
135 Novo Nordisk Investigational Site Houston Texas United States 77054
136 Novo Nordisk Investigational Site Houston Texas United States 77079
137 Novo Nordisk Investigational Site Houston Texas United States 77084
138 Novo Nordisk Investigational Site Houston Texas United States 77090
139 Novo Nordisk Investigational Site Live Oak Texas United States 78233
140 Novo Nordisk Investigational Site Longview Texas United States 75605
141 Novo Nordisk Investigational Site Lufkin Texas United States 75904
142 Novo Nordisk Investigational Site Rockwall Texas United States 75032
143 Novo Nordisk Investigational Site San Antonio Texas United States 78212
144 Novo Nordisk Investigational Site San Antonio Texas United States 78215
145 Novo Nordisk Investigational Site San Antonio Texas United States 78224
146 Novo Nordisk Investigational Site San Antonio Texas United States 78230
147 Novo Nordisk Investigational Site San Marcos Texas United States 78666
148 Novo Nordisk Investigational Site Sugar Land Texas United States 77478
149 Novo Nordisk Investigational Site Waco Texas United States 76708
150 Novo Nordisk Investigational Site Webster Texas United States 77598
151 Novo Nordisk Investigational Site Forest Virginia United States 24551
152 Novo Nordisk Investigational Site Norfolk Virginia United States 23510-2015
153 Novo Nordisk Investigational Site Richmond Virginia United States 23298-5058
154 Novo Nordisk Investigational Site Salem Virginia United States 24153-6404
155 Novo Nordisk Investigational Site Winchester Virginia United States 22601-3834
156 Novo Nordisk Investigational Site Spokane Washington United States 99204
157 Novo Nordisk Investigational Site Wausau Wisconsin United States 54401
158 Novo Nordisk Investigational Site Buenos Aires Argentina B6000BHA
159 Novo Nordisk Investigational Site Caba Argentina C1213
160 Novo Nordisk Investigational Site Caba Argentina C1428ART
161 Novo Nordisk Investigational Site Caba Argentina C1440CFD
162 Novo Nordisk Investigational Site Ciudad Autónoma de Buenos Aire Argentina 1425
163 Novo Nordisk Investigational Site Mar del Plata Argentina B7600GNY
164 Novo Nordisk Investigational Site Quilmes - Buenos Aires Argentina B1878DVB
165 Novo Nordisk Investigational Site San Nicolás Argentina B2900
166 Novo Nordisk Investigational Site Garran Australian Capital Territory Australia 2605
167 Novo Nordisk Investigational Site Gosford New South Wales Australia 2250
168 Novo Nordisk Investigational Site Milton Queensland Australia 4064
169 Novo Nordisk Investigational Site Adelaide South Australia Australia 5000
170 Novo Nordisk Investigational Site Clayton Victoria Australia 3168
171 Novo Nordisk Investigational Site Fitzroy Victoria Australia 3065
172 Novo Nordisk Investigational Site Geelong Victoria Australia 3220
173 Novo Nordisk Investigational Site Joondalup Western Australia Australia 6027
174 Novo Nordisk Investigational Site Aalst Belgium 9300
175 Novo Nordisk Investigational Site Brasschaat Belgium 2930
176 Novo Nordisk Investigational Site Brugge Belgium 8000
177 Novo Nordisk Investigational Site Genk Belgium 3600
178 Novo Nordisk Investigational Site Kortrijk Belgium 8500
179 Novo Nordisk Investigational Site Liège Belgium 4000
180 Novo Nordisk Investigational Site Mechelen Belgium 2800
181 Novo Nordisk Investigational Site Vitória Espirito Santo Brazil 29055-450
182 Novo Nordisk Investigational Site Curitiba Parana Brazil 80440-020
183 Novo Nordisk Investigational Site Curitiba Parana Brazil 80730-150
184 Novo Nordisk Investigational Site Blumenau Santa Catarina Brazil 89020-430
185 Novo Nordisk Investigational Site Campinas Sao Paulo Brazil 13010-001
186 Novo Nordisk Investigational Site Campinas Sao Paulo Brazil 13060-080
187 Novo Nordisk Investigational Site São José do Rio Preto Sao Paulo Brazil 15090-000
188 Novo Nordisk Investigational Site Pleven Bulgaria 5800
189 Novo Nordisk Investigational Site Plovdiv Bulgaria 4002
190 Novo Nordisk Investigational Site Sofia Bulgaria 1309
191 Novo Nordisk Investigational Site Sofia Bulgaria 1407
192 Novo Nordisk Investigational Site Sofia Bulgaria 1431
193 Novo Nordisk Investigational Site Sofia Bulgaria 1431
194 Novo Nordisk Investigational Site Sofia Bulgaria 1527
195 Novo Nordisk Investigational Site Sofia Bulgaria 1750
196 Novo Nordisk Investigational Site Varna Bulgaria 9010
197 Novo Nordisk Investigational Site Calgary Alberta Canada T2H 2G4
198 Novo Nordisk Investigational Site Calgary Alberta Canada T2V 4J2
199 Novo Nordisk Investigational Site Sherwood Park Alberta Canada T8H 0N2
200 Novo Nordisk Investigational Site Vancouver British Columbia Canada V5Y 3W2
201 Novo Nordisk Investigational Site Halifax Nova Scotia Canada B3H 2Y9
202 Novo Nordisk Investigational Site Barrie Ontario Canada L4N 7L3
203 Novo Nordisk Investigational Site Brampton Ontario Canada L6S 0C6
204 Novo Nordisk Investigational Site Concord Ontario Canada L4K 4M2
205 Novo Nordisk Investigational Site Etobicoke Ontario Canada M9R 4E1
206 Novo Nordisk Investigational Site Hamilton Ontario Canada L8M 1K7
207 Novo Nordisk Investigational Site Nepean Ontario Canada K2J 0V2
208 Novo Nordisk Investigational Site North York Ontario Canada M6B 3H7
209 Novo Nordisk Investigational Site Oakville Ontario Canada L6K 3W7
210 Novo Nordisk Investigational Site Oakville Ontario Canada L6M 1M1
211 Novo Nordisk Investigational Site Peterborough Ontario Canada K9J 0B2
212 Novo Nordisk Investigational Site Scarborough Ontario Canada M1B 4Z8
213 Novo Nordisk Investigational Site Toronto Ontario Canada M4G 3E8
214 Novo Nordisk Investigational Site Toronto Ontario Canada M6G 1M2
215 Novo Nordisk Investigational Site Waterloo Ontario Canada N2T 0C1
216 Novo Nordisk Investigational Site Brossard Quebec Canada J4Z-2K9
217 Novo Nordisk Investigational Site Laval Quebec Canada H7T 2P5
218 Novo Nordisk Investigational Site Sherbrooke Quebec Canada J1H 5N4
219 Novo Nordisk Investigational Site Quebec Canada G1G 3Y8
220 Novo Nordisk Investigational Site Beijing Beijing China 100191
221 Novo Nordisk Investigational Site Beijing Beijing China 100853
222 Novo Nordisk Investigational Site Chongqing Chongqing China 402260
223 Novo Nordisk Investigational Site Wuhan Hubei China 430022
224 Novo Nordisk Investigational Site Changzhou Jiangsu China 213003
225 Novo Nordisk Investigational Site Shanghai Shanghai China 200080
226 Novo Nordisk Investigational Site Shanghai Shanghai China 201199
227 Novo Nordisk Investigational Site Aarhus N Denmark 8200
228 Novo Nordisk Investigational Site Herning Denmark 7400
229 Novo Nordisk Investigational Site Hvidovre Denmark 2650
230 Novo Nordisk Investigational Site Svendborg Denmark 5700
231 Novo Nordisk Investigational Site Aachen Germany 52074
232 Novo Nordisk Investigational Site Bad Homburg Germany 61348
233 Novo Nordisk Investigational Site Dresden Germany 01277
234 Novo Nordisk Investigational Site Düsseldorf Germany 40210
235 Novo Nordisk Investigational Site Elsterwerda Germany 04910
236 Novo Nordisk Investigational Site Essen Germany 45136
237 Novo Nordisk Investigational Site Falkensee Germany 14612
238 Novo Nordisk Investigational Site Lübeck Germany 23562
239 Novo Nordisk Investigational Site Oldenburg I. Holst Germany 23758
240 Novo Nordisk Investigational Site Witten Germany 58455
241 Novo Nordisk Investigational Site Athens Greece 11527
242 Novo Nordisk Investigational Site Athens Greece GR-11527
243 Novo Nordisk Investigational Site Athens Greece GR-11528
244 Novo Nordisk Investigational Site Athens Greece GR-14233
245 Novo Nordisk Investigational Site Athens Greece GR-15123
246 Novo Nordisk Investigational Site Chios Greece GR82100
247 Novo Nordisk Investigational Site Haidari-Athens Greece GR-12462
248 Novo Nordisk Investigational Site Ioannina Greece 45500
249 Novo Nordisk Investigational Site Kifissia Greece GR-14561
250 Novo Nordisk Investigational Site Lamia Greece GR35100
251 Novo Nordisk Investigational Site Larissa Greece GR-41110
252 Novo Nordisk Investigational Site Patra Greece GR-26504
253 Novo Nordisk Investigational Site Thessaloniki Greece GR-57010
254 Novo Nordisk Investigational Site Vijayawada Andhra Pradesh India 520002
255 Novo Nordisk Investigational Site Mangalore Karnataka India 575002
256 Novo Nordisk Investigational Site Manipal Karnataka India 576104
257 Novo Nordisk Investigational Site Nagpur Maharashtra India 440003
258 Novo Nordisk Investigational Site Nagpur Maharashtra India 440010
259 Novo Nordisk Investigational Site New Dehli New Delhi India 110029
260 Novo Nordisk Investigational Site Hyderabad Telengana India 500012
261 Novo Nordisk Investigational Site Lucknow Uttar Pradesh India 226030
262 Novo Nordisk Investigational Site Belgaum India 590010
263 Novo Nordisk Investigational Site New Delhi India 110002
264 Novo Nordisk Investigational Site New Delhi India 110060
265 Novo Nordisk Investigational Site Holon Israel 58100
266 Novo Nordisk Investigational Site Jerusalem Israel 91120
267 Novo Nordisk Investigational Site Rehovot Israel 7661041
268 Novo Nordisk Investigational Site Tel Aviv Israel 6423906
269 Novo Nordisk Investigational Site Tel Hashomer Israel 5265601
270 Novo Nordisk Investigational Site Arzignano (VI) Italy 36071
271 Novo Nordisk Investigational Site Bologna Italy 40138
272 Novo Nordisk Investigational Site Catania Italy 95126
273 Novo Nordisk Investigational Site Catanzaro Italy 88100
274 Novo Nordisk Investigational Site Milano Italy 20138
275 Novo Nordisk Investigational Site Milan Italy 20132
276 Novo Nordisk Investigational Site Montichiari Italy 25018
277 Novo Nordisk Investigational Site Roma Italy 00168
278 Novo Nordisk Investigational Site Rome Italy 00189
279 Novo Nordisk Investigational Site Trieste Italy 34128
280 Novo Nordisk Investigational Site Verona Italy 37126
281 Novo Nordisk Investigational Site Bunkyo-ku, Tokyo Japan 113-8655
282 Novo Nordisk Investigational Site Fukuoka-shi, Fukuoka Japan 810-0001
283 Novo Nordisk Investigational Site Fukushima Japan 963-8851
284 Novo Nordisk Investigational Site Hamada-shi, Shimane Japan 697-8511
285 Novo Nordisk Investigational Site Ibaraki Japan 311-0113
286 Novo Nordisk Investigational Site Kishiwada, Osaka Japan 596-0042
287 Novo Nordisk Investigational Site Kita-azumi-gun, Nagano Japan 399-8695
288 Novo Nordisk Investigational Site Kumamoto-shi, Kumamoto Japan 860-8556
289 Novo Nordisk Investigational Site Kumamoto Japan 862-0976
290 Novo Nordisk Investigational Site Kusegun, Kyoto Japan 613-0034
291 Novo Nordisk Investigational Site Kyoto-shi, Kyoto Japan 607-8062
292 Novo Nordisk Investigational Site Kyoto-shi,Kyoto Japan 601-1495
293 Novo Nordisk Investigational Site Matsudo-shi Japan 270-2251
294 Novo Nordisk Investigational Site Matsumoto-shi, Nagano Japan 390-8621
295 Novo Nordisk Investigational Site Meguro-ku, Tokyo Japan 153-0051
296 Novo Nordisk Investigational Site Nagoya-shi, Aichi Japan 457-0818
297 Novo Nordisk Investigational Site Naha-shi, Okinawa Japan 902-8511
298 Novo Nordisk Investigational Site Okayama Japan 701-0192
299 Novo Nordisk Investigational Site Omihachiman-shi, Siga Japan 523-0082
300 Novo Nordisk Investigational Site Osaka-shi, Osaka Japan 533-0024
301 Novo Nordisk Investigational Site Osaka-shi,Osaka Japan 559-0012
302 Novo Nordisk Investigational Site Sagamihara-shi, Kanagawa Japan 252-0392
303 Novo Nordisk Investigational Site Saitama-shi, Saitama Japan 338-0837
304 Novo Nordisk Investigational Site Sapporo-shi, Hokkaido Japan 062-0003
305 Novo Nordisk Investigational Site Sendai-shi, Miyagi Japan 980-8574
306 Novo Nordisk Investigational Site Suita-shi, Osaka Japan 564-0013
307 Novo Nordisk Investigational Site Takamatsu-shi, Kagawa Japan 760-8557
308 Novo Nordisk Investigational Site Tokyo Japan 192-0918
309 Novo Nordisk Investigational Site Wako-shi, Saitama Japan 351-0102
310 Novo Nordisk Investigational Site Yao-shi, Osaka Japan 581-0011
311 Novo Nordisk Investigational Site Yokohama-shi, Kanagawa Japan 236-0004
312 Novo Nordisk Investigational Site Yonezawa-shi, Yamagata Japan 992-0045
313 Novo Nordisk Investigational Site Busan Korea, Republic of 49201
314 Novo Nordisk Investigational Site Busan Korea, Republic of 49241
315 Novo Nordisk Investigational Site Daegu Korea, Republic of 42472
316 Novo Nordisk Investigational Site Daegu Korea, Republic of 42601
317 Novo Nordisk Investigational Site Daejeon Korea, Republic of 35015
318 Novo Nordisk Investigational Site Gangwon-do Korea, Republic of 26426
319 Novo Nordisk Investigational Site Gwangju Korea, Republic of 61469
320 Novo Nordisk Investigational Site Gyeonggi-do Korea, Republic of 13620
321 Novo Nordisk Investigational Site Incheon Korea, Republic of 21565
322 Novo Nordisk Investigational Site Seoul Korea, Republic of 02841
323 Novo Nordisk Investigational Site Seoul Korea, Republic of 03722
324 Novo Nordisk Investigational Site Seoul Korea, Republic of 05278
325 Novo Nordisk Investigational Site Seoul Korea, Republic of 06591
326 Novo Nordisk Investigational Site Seoul Korea, Republic of 08308
327 Novo Nordisk Investigational Site Kaunas Lithuania 48259
328 Novo Nordisk Investigational Site Kaunas Lithuania 49449
329 Novo Nordisk Investigational Site Siauliai Lithuania 76231
330 Novo Nordisk Investigational Site Alor Setar Malaysia 05460
331 Novo Nordisk Investigational Site Ipoh, Perak Malaysia 30450
332 Novo Nordisk Investigational Site Kedah Malaysia 08000
333 Novo Nordisk Investigational Site Kota Bharu, Kelantan Malaysia 16150
334 Novo Nordisk Investigational Site Kota Bharu Malaysia 15586
335 Novo Nordisk Investigational Site Kota Samarahan Malaysia 94300
336 Novo Nordisk Investigational Site Kuala Lumpur Malaysia 59100
337 Novo Nordisk Investigational Site Sabah Malaysia 88300
338 Novo Nordisk Investigational Site Seremban Malaysia 70300
339 Novo Nordisk Investigational Site Mexico City México, D.F. Mexico 03300
340 Novo Nordisk Investigational Site Monterrey Nuevo León Mexico 64020
341 Novo Nordisk Investigational Site Monterrey Nuevo León Mexico 64060
342 Novo Nordisk Investigational Site Monterrey Nuevo León Mexico 64460
343 Novo Nordisk Investigational Site San Luis Potosí San Luis Potosi Mexico 78200
344 Novo Nordisk Investigational Site Culiacán Sinaloa Mexico 80230
345 Novo Nordisk Investigational Site Aguascalientes Mexico 20230
346 Novo Nordisk Investigational Site Queretaro Mexico 76000
347 Novo Nordisk Investigational Site Veracruz Mexico 91900
348 Novo Nordisk Investigational Site Alkmaar Netherlands 1815 JD
349 Novo Nordisk Investigational Site Almelo Netherlands 7609 PP
350 Novo Nordisk Investigational Site Amsterdam Netherlands 1105 AZ
351 Novo Nordisk Investigational Site Apeldoorn Netherlands 7334 DZ
352 Novo Nordisk Investigational Site Hilversum Netherlands 1213 XZ
353 Novo Nordisk Investigational Site Leiden Netherlands 2333 ZA
354 Novo Nordisk Investigational Site Rotterdam Netherlands 3083 AN
355 Novo Nordisk Investigational Site Sneek Netherlands 8601 ZR
356 Novo Nordisk Investigational Site Zaandam Netherlands 1502 DV
357 Novo Nordisk Investigational Site Bialystok Poland 15-276
358 Novo Nordisk Investigational Site Bialystok Poland 15-481
359 Novo Nordisk Investigational Site Elblag Poland 82-300
360 Novo Nordisk Investigational Site Gorzow Wielkopolski Poland 66-400
361 Novo Nordisk Investigational Site Grodzisk Mazowiecki Poland 05-825
362 Novo Nordisk Investigational Site Krakow Poland 30-082
363 Novo Nordisk Investigational Site Krakow Poland 31-209
364 Novo Nordisk Investigational Site Krakow Poland 31-261
365 Novo Nordisk Investigational Site Krakow Poland 31-261
366 Novo Nordisk Investigational Site Kraków Poland 31-202
367 Novo Nordisk Investigational Site Lodz Poland 90-242
368 Novo Nordisk Investigational Site Lodz Poland 90-549
369 Novo Nordisk Investigational Site Lodz Poland 91-211
370 Novo Nordisk Investigational Site Lublin Poland 20-044
371 Novo Nordisk Investigational Site Pulawy Poland 24-100
372 Novo Nordisk Investigational Site Ruda Slaska Poland 41-710
373 Novo Nordisk Investigational Site Szczecin Poland 70-341
374 Novo Nordisk Investigational Site Warszawa Poland 04-628
375 Novo Nordisk Investigational Site Warszawa Poland 04-628
376 Novo Nordisk Investigational Site Wroclaw Poland 51-162
377 Novo Nordisk Investigational Site Zamosc Poland 22-400
378 Novo Nordisk Investigational Site Almada Portugal 2805-267
379 Novo Nordisk Investigational Site Aveiro Portugal 3814-501
380 Novo Nordisk Investigational Site Braga Portugal 4710-243
381 Novo Nordisk Investigational Site Carnaxide Portugal 2790-134
382 Novo Nordisk Investigational Site Coimbra Portugal 3000-561
383 Novo Nordisk Investigational Site Lisboa Portugal 1649-035
384 Novo Nordisk Investigational Site Matosinhos Portugal 4464-513
385 Novo Nordisk Investigational Site Barnaul Russian Federation 656055
386 Novo Nordisk Investigational Site Chita Russian Federation 672000
387 Novo Nordisk Investigational Site Irkutsk Russian Federation 664049
388 Novo Nordisk Investigational Site Kazan Russian Federation 420029
389 Novo Nordisk Investigational Site Kazan Russian Federation 420101
390 Novo Nordisk Investigational Site Moscow Russian Federation 129226
391 Novo Nordisk Investigational Site Moscow Russian Federation 129327
392 Novo Nordisk Investigational Site Novosibirsk Russian Federation 630087
393 Novo Nordisk Investigational Site Novosibirsk Russian Federation 630099
394 Novo Nordisk Investigational Site Petrozavodsk Russian Federation 185019
395 Novo Nordisk Investigational Site Sochi Russian Federation 354057
396 Novo Nordisk Investigational Site Tomsk Russian Federation 634034
397 Novo Nordisk Investigational Site Belgrade Serbia 11000
398 Novo Nordisk Investigational Site Kragujevac Serbia 34000
399 Novo Nordisk Investigational Site Novi Sad Serbia 21000
400 Novo Nordisk Investigational Site Bratislava Slovakia 81369
401 Novo Nordisk Investigational Site Bratislava Slovakia 831 06
402 Novo Nordisk Investigational Site Bratislava Slovakia 83305
403 Novo Nordisk Investigational Site Kosice Slovakia 040 01
404 Novo Nordisk Investigational Site Lubochna Slovakia 03491
405 Novo Nordisk Investigational Site Martin Slovakia 036 59
406 Novo Nordisk Investigational Site Presov Slovakia 08-181
407 Novo Nordisk Investigational Site Bloemfontein Free State South Africa 9301
408 Novo Nordisk Investigational Site Bloemfontein Free State South Africa 9301
409 Novo Nordisk Investigational Site Centurion Gauteng South Africa 0157
410 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 2013
411 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 2157
412 Novo Nordisk Investigational Site Johannesburg Gauteng South Africa 2193
413 Novo Nordisk Investigational Site Pretoria Gauteng South Africa 0183
414 Novo Nordisk Investigational Site Pretoria Gauteng South Africa 0184
415 Novo Nordisk Investigational Site Pretoria Gauteng South Africa 0186
416 Novo Nordisk Investigational Site Cape Town Western Cape South Africa 7130
417 Novo Nordisk Investigational Site Cape Town Western Cape South Africa 7130
418 Novo Nordisk Investigational Site Cape Town Western Cape South Africa 7500
419 Novo Nordisk Investigational Site Cape Town Western Cape South Africa 7925
420 Novo Nordisk Investigational Site Paarl Western Cape South Africa 7646
421 Novo Nordisk Investigational Site Baracaldo Spain 48903
422 Novo Nordisk Investigational Site Córdoba Spain 14004
423 Novo Nordisk Investigational Site L' Hospitalet Del Llobregat Spain 08907
424 Novo Nordisk Investigational Site Sanlúcar de Barrameda Spain 11540
425 Novo Nordisk Investigational Site Valencia Spain 46010
426 Novo Nordisk Investigational Site Valencia Spain 46017
427 Novo Nordisk Investigational Site Zaragoza Spain 50009
428 Novo Nordisk Investigational Site Lund Sweden 222 21
429 Novo Nordisk Investigational Site Malmö Sweden 205 02
430 Novo Nordisk Investigational Site Stockholm Sweden 141 85
431 Novo Nordisk Investigational Site Stockholm Sweden 171 64
432 Novo Nordisk Investigational Site Uppsala Sweden 751 85
433 Novo Nordisk Investigational Site Hsinchu City Taiwan 300
434 Novo Nordisk Investigational Site Tainan City Taiwan 704
435 Novo Nordisk Investigational Site Taipei Taiwan 100
436 Novo Nordisk Investigational Site Taipei Taiwan 112
437 Novo Nordisk Investigational Site Taoyuan City Taiwan 333
438 Novo Nordisk Investigational Site Afyon Turkey 03200
439 Novo Nordisk Investigational Site Ankara Turkey 06230
440 Novo Nordisk Investigational Site Ankara Turkey 06230
441 Novo Nordisk Investigational Site Antalya Turkey 07058
442 Novo Nordisk Investigational Site Aydin Turkey 09100
443 Novo Nordisk Investigational Site Eskisehir Turkey 26040
444 Novo Nordisk Investigational Site Istanbul Turkey 34098
445 Novo Nordisk Investigational Site Istanbul Turkey 34098
446 Novo Nordisk Investigational Site Istanbul Turkey 34381
447 Novo Nordisk Investigational Site Istanbul Turkey 34668
448 Novo Nordisk Investigational Site Izmir Turkey 35100
449 Novo Nordisk Investigational Site Izmir Turkey 35340
450 Novo Nordisk Investigational Site Kahramanmaras Turkey 46040
451 Novo Nordisk Investigational Site Kayseri Turkey 38039
452 Novo Nordisk Investigational Site Kocaeli Turkey 41380
453 Novo Nordisk Investigational Site Mugla Turkey 48000
454 Novo Nordisk Investigational Site Chernivtsi Ukraine 58023
455 Novo Nordisk Investigational Site Ivano-Frankivsk Ukraine 76008
456 Novo Nordisk Investigational Site Kharkiv Ukraine 61039
457 Novo Nordisk Investigational Site Kharkiv Ukraine 61178
458 Novo Nordisk Investigational Site Kyiv Ukraine 02091
459 Novo Nordisk Investigational Site Kyiv Ukraine 02660
460 Novo Nordisk Investigational Site Kyiv Ukraine 03037
461 Novo Nordisk Investigational Site Kyiv Ukraine 03049
462 Novo Nordisk Investigational Site Kyiv Ukraine 03151
463 Novo Nordisk Investigational Site Kyiv Ukraine 03680
464 Novo Nordisk Investigational Site Kyiv Ukraine 04050
465 Novo Nordisk Investigational Site Kyiv Ukraine 04053
466 Novo Nordisk Investigational Site Zaporizhzhia Ukraine 69063
467 Novo Nordisk Investigational Site Zhytomyr Ukraine 10002
468 Novo Nordisk Investigational Site Addlestone United Kingdom KT15 2BH
469 Novo Nordisk Investigational Site Barnet United Kingdom EN5 3DJ
470 Novo Nordisk Investigational Site Bradford-on-Avon United Kingdom BA15 1DQ
471 Novo Nordisk Investigational Site Bradford United Kingdom BD9 6RJ
472 Novo Nordisk Investigational Site Denmark Hill, London United Kingdom SE5 9RS
473 Novo Nordisk Investigational Site Dorest United Kingdom BH7 7DW
474 Novo Nordisk Investigational Site Dorset United Kingdom BH16 5PW
475 Novo Nordisk Investigational Site Exeter United Kingdom EX2 5DW
476 Novo Nordisk Investigational Site High Wycombe United Kingdom HP11 2TT
477 Novo Nordisk Investigational Site Leicester United Kingdom LE3 9QP
478 Novo Nordisk Investigational Site Lincoln United Kingdom LN2 5QY
479 Novo Nordisk Investigational Site Newcastle Upon Tyne United Kingdom NE7 7DN
480 Novo Nordisk Investigational Site Oxford United Kingdom OX3 9DU
481 Novo Nordisk Investigational Site Sandbach United Kingdom CW11 1EQ
482 Novo Nordisk Investigational Site Stockton-on-Tees United Kingdom TS19 8PE
483 Novo Nordisk Investigational Site Taunton United Kingdom TA1 5DA
484 Novo Nordisk Investigational Site Torquay United Kingdom TQ2 7AA
485 Novo Nordisk Investigational Site Wellingborough United Kingdom NN8 4RW
486 Novo Nordisk Investigational Site West Sussex United Kingdom PO19 6SE

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT05021835
Other Study ID Numbers:
  • EX6018-4758
  • U1111-1259-3422
  • 2020-004853-59
  • jRCT2021210033
First Posted:
Aug 26, 2021
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2022