ESSENCE: Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04822181
Collaborator
(none)
1,200
370
2
85.8
3.2
0
Study Details
Study Description
Brief Summary
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries.
Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance.
Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week.
The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day.
Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures
The trial has two parts, a part 1 and a part 2, in part 2 sponsor will be unblinded
Primary Purpose:
Treatment
Official Title:
The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis
Actual Study Start Date
:
Apr 1, 2021
Anticipated Primary Completion Date
:
Apr 7, 2028
Anticipated Study Completion Date
:
May 26, 2028
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Semaglutide OW (once weekly ) Semaglutide administrated subcutaneously once weekly |
Drug: Semaglutide
Semaglutide administrated subcutaneously (under the skin) once weekly there will be a period of dose escalation before reaching the target dose.
|
| Placebo Comparator: Placebo Placebo administrated subcutaneously once weekly |
Drug: Placebo
Placebo administrated subcutaneously (under the skin) once weekly.
|
Outcome Measures
Primary Outcome Measures
- Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) [From randomisation (week 0) to week 72]
Count of subjects (Resolution of steatohepatitis is defined as a NAFLD Activity Score (NAS) of 0-1 for inflammation, 0 for ballooning, and any value for steatosis (According to NASH CRN). Fibrosis is graded on the NASH CRN fibrosis scale from 0 to 4. )
- Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No) [From randomisation (week 0) to week 72]
Count of subjects ( Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale. No worsening of steatohepatitis is defined as no increase from baseline in NAS score for ballooning, inflammation, or steatosis. )
- Part 2: Time to first liver-related clinical event (composite endpoint) [From randomisation (week 0) to week 240]
Days (The liver-related clinical event composite endpoint consists of: histological progression to cirrhosis, all-cause mortality, liver-induced MELD score greater than or equal to 15, liver transplant or hepatic decompensation events (ascites leading to treatment (diuretics, parascentesis and/or TIPS), spontaneous bacterial peritonitis (identified by analysis of ascites fluid (a polymorphonuclear cell count in the ascitic fluid greater than or equal to 250 cells/mm3 and/or a positive bacterial ascitic fluid culture) and/or a clinical assessment consistent with spontaneous bacterial peritonitis), hepatic encephalopathy greater than or equal to grade 2 according to the West Haven criteria or hospitalisation for gastro-oesophageal variceal bleeding).
Secondary Outcome Measures
- Progression of liver fibrosis (Yes/No) [From randomisation (week 0) to week 72]
Count of subjects
- Change in body weight [From randomisation (week 0) to week 72]
Percentage
- Change in SF-36 (Short Form 36) Bodily Pain [From randomisation (week 0) to week 72]
Score points
- Change in body weight [From randomisation (week 0) to week 240]
Percentage
- Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No) [From randomisation (week 0) to week 72]
Count of subjects (The 2-point reduction needs to include at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning)
- Change in histology-assessed liver collagen proportionate area [From randomisation (week 0) to week 72]
Ratio to baseline
- Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No) [From randomisation (week 0) to week 72]
Count of subjects
- Worsening in steatohepatitis (Yes/No) [From randomisation (week 0) to week 72]
Count of subjects (Defined as increase in NAS for ballooning, inflammation, or steatosis)
- Improvement in histology-assessed ballooning (Yes/No) [From randomisation (week 0) to week 72]
Count of subjects
- Improvement in histology-assessed inflammation (Yes/No) [From randomisation (week 0) to week 72]
Count of subjects
- Improvement in histology-assessed steatosis (Yes/No) [From randomisation (week 0) to week 72]
Count of subjects
- Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) [From randomisation (week 0) to week 240]
Count of subjects
- Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No) [From randomisation (week 0) to week 240]
Count of subjects
- Change in ALT (alanine aminotransferase) [From randomisation (week 0) to week 72]
Ratio to baseline
- Change in AST (aspartate aminotransferase) [From randomisation (week 0) to week 72]
Ratio to baseline
- Change in inflammation assessed by hsCRP (High Sensitive C-Reactive Protein) [From randomisation (week 0) to week 72]
Ratio to baseline
- Change in HbA1c (glycated haemoglobin) [From randomisation (week 0) to week 72]
Percentage-points (absolute change) (For subjects with type 2 diabetes)
- Change in triglyceride [From randomisation (week 0) to week 72]
Ratio to baseline
- Change in free fatty acids [From randomisation (week 0) to week 72]
Ratio to baseline
- Change in LDL (low-density lipoprotein) cholesterol [From randomisation (week 0) to week 72]
Ratio to baseline
- Change in HDL (High density lipoprotein ) cholesterol [From randomisation (week 0) to week 72]
Ratio to baseline
- Changes in SF-36 (Short Form 36 v2.0 acute ) Physical Component Summary [From randomisation (week 0) to week 72]
Score points
- Changes in SF-36 Mental Component Summary [From randomisation (week 0) to week 72]
Score points
- Changes in NASH-CHECK Pain [From randomisation (week 0) to week 72]
Score points
- Time to first MACE(Major Adverse Cardiovascular event ) (composite endpoint) [From randomisation (week 0) to week 240]
Days (The MACE composite endpoint consists of: cardiovascular death, non-fatal myocardial infarction or non-fatal stroke)
- Time to first major cardio-hepatic event (composite endpoint) [From randomisation (week 0) to week 240]
Days (The major cardio-hepatic event composite endpoint consists of: MACE, liver-related death, histological progression to cirrhosis, liver-induced MELD score above or equal to 15, liver transplant or hepatic decompensation event)
- Change in liver stiffness assessed by FibroScan® [From randomisation (week 0) to week 72]
Ratio to baseline (FibroScan® will only be assessed at sites that has the equipment available)
- Change in ELF (Enhanced Liver Fibrosis) score [From randomisation (week 0) to week 72]
Logarithm
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age above or equal to 18 years at the time of signing informed consent.
-
Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to the screening visit (V1).
-
Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN (Clinical Research Network) classification based on a central pathologist evaluation of the baseline liver biopsy.
-
A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal to 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.
Exclusion Criteria:
-
Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)
-
Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
-
Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
-
Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
-
Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in from time of biopsy until screening.
-
Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).
-
Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Huntsville | Alabama | United States | 35801 |
| 2 | Novo Nordisk Investigational Site | Chandler | Arizona | United States | 85224 |
| 3 | Novo Nordisk Investigational Site | Peoria | Arizona | United States | 85381 |
| 4 | Novo Nordisk Investigational Site | Tucson | Arizona | United States | 85712 |
| 5 | Novo Nordisk Investigational Site | Tucson | Arizona | United States | 85715 |
| 6 | Novo Nordisk Investigational Site | Little Rock | Arkansas | United States | 72205 |
| 7 | Novo Nordisk Investigational Site | Hacienda Heights | California | United States | 91745 |
| 8 | Novo Nordisk Investigational Site | La Jolla | California | United States | 92037 |
| 9 | Novo Nordisk Investigational Site | Lancaster | California | United States | 93534 |
| 10 | Novo Nordisk Investigational Site | Long Beach | California | United States | 90808 |
| 11 | Novo Nordisk Investigational Site | Pasadena | California | United States | 90048 |
| 12 | Novo Nordisk Investigational Site | Rialto | California | United States | 92377 |
| 13 | Novo Nordisk Investigational Site | Sacramento | California | United States | 95757 |
| 14 | Novo Nordisk Investigational Site | San Francisco | California | United States | 94143-0780 |
| 15 | Novo Nordisk Investigational Site | San Jose | California | United States | 95116 |
| 16 | Novo Nordisk Investigational Site | Doral | Florida | United States | 33166 |
| 17 | Novo Nordisk Investigational Site | Gainesville | Florida | United States | 32610 |
| 18 | Novo Nordisk Investigational Site | Hialeah | Florida | United States | 33012 |
| 19 | Novo Nordisk Investigational Site | Hialeah | Florida | United States | 33016 |
| 20 | Novo Nordisk Investigational Site | Maitland | Florida | United States | 32751 |
| 21 | Novo Nordisk Investigational Site | Miami Lakes | Florida | United States | 33014 |
| 22 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33125 |
| 23 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33136 |
| 24 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33173 |
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| 29 | Novo Nordisk Investigational Site | Zephyrhills | Florida | United States | 33542 |
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| 98 | Novo Nordisk Investigational Site | Florencio Varela, Buenos Aires | Argentina | 1888 | |
| 99 | Novo Nordisk Investigational Site | Rosario, Santa Fe | Argentina | S2002KDT | |
| 100 | Novo Nordisk Investigational Site | Camperdown | New South Wales | Australia | 2050 |
| 101 | Novo Nordisk Investigational Site | Kingswood | New South Wales | Australia | 2747 |
| 102 | Novo Nordisk Investigational Site | Westmead | New South Wales | Australia | 2145 |
| 103 | Novo Nordisk Investigational Site | Elizabeth Vale | South Australia | Australia | 5112 |
| 104 | Novo Nordisk Investigational Site | Fitzroy | Victoria | Australia | 3065 |
| 105 | Novo Nordisk Investigational Site | Heidelberg | Victoria | Australia | 3084 |
| 106 | Novo Nordisk Investigational Site | Nedlands | Western Australia | Australia | 6009 |
| 107 | Novo Nordisk Investigational Site | Graz | Austria | 8036 | |
| 108 | Novo Nordisk Investigational Site | Salzburg | Austria | 5020 | |
| 109 | Novo Nordisk Investigational Site | Wels | Austria | 4600 | |
| 110 | Novo Nordisk Investigational Site | Wien | Austria | 1030 | |
| 111 | Novo Nordisk Investigational Site | Bruxelles | Belgium | 1070 | |
| 112 | Novo Nordisk Investigational Site | Bruxelles | Belgium | 1200 | |
| 113 | Novo Nordisk Investigational Site | Edegem | Belgium | 2650 | |
| 114 | Novo Nordisk Investigational Site | Genk | Belgium | 3600 | |
| 115 | Novo Nordisk Investigational Site | Gent | Belgium | 9000 | |
| 116 | Novo Nordisk Investigational Site | Salvador | Bahia | Brazil | 40110160 |
| 117 | Novo Nordisk Investigational Site | Goiânia | Goias | Brazil | 74605-020 |
| 118 | Novo Nordisk Investigational Site | Botucatu | Sao Paulo | Brazil | 18618-686 |
| 119 | Novo Nordisk Investigational Site | São José do Rio Preto | Sao Paulo | Brazil | 15090-000 |
| 120 | Novo Nordisk Investigational Site | São Paulo | Sao Paulo | Brazil | 04024-000 |
| 121 | Novo Nordisk Investigational Site | São Paulo | Sao Paulo | Brazil | 05403-000 |
| 122 | Novo Nordisk Investigational Site | Rio de Janeiro | Brazil | 21941-913 | |
| 123 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1407 | |
| 124 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1431 | |
| 125 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1527 | |
| 126 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1750 | |
| 127 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1784 | |
| 128 | Novo Nordisk Investigational Site | Varna | Bulgaria | 9010 | |
| 129 | Novo Nordisk Investigational Site | Calgary | Alberta | Canada | T2N 4Z6 |
| 130 | Novo Nordisk Investigational Site | Vancouver | British Columbia | Canada | V6Z 2K5 |
| 131 | Novo Nordisk Investigational Site | London | Ontario | Canada | N6A 5A5 |
| 132 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M6H 3M1 |
| 133 | Novo Nordisk Investigational Site | Vaughan | Ontario | Canada | L4L 4Y7 |
| 134 | Novo Nordisk Investigational Site | Chicoutimi | Quebec | Canada | G7H 7K9 |
| 135 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H4A 3J1 |
| 136 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | QC H2L 4E9 |
| 137 | Novo Nordisk Investigational Site | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 138 | Novo Nordisk Investigational Site | Terrebonne | Quebec | Canada | J6X 4P7 |
| 139 | Novo Nordisk Investigational Site | Beijing | Beijing | China | 100015 |
| 140 | Novo Nordisk Investigational Site | Beijing | Beijing | China | 100034 |
| 141 | Novo Nordisk Investigational Site | Beijing | Beijing | China | 100069 |
| 142 | Novo Nordisk Investigational Site | Beijing | Beijing | China | 102218 |
| 143 | Novo Nordisk Investigational Site | Chongqing | Chongqing | China | 404140 |
| 144 | Novo Nordisk Investigational Site | Foshan | Guangdong | China | 528000 |
| 145 | Novo Nordisk Investigational Site | Guangzhou | Guangdong | China | 510180 |
| 146 | Novo Nordisk Investigational Site | Guangzhou | Guangdong | China | 510515 |
| 147 | Novo Nordisk Investigational Site | Guangzhou | Guangdong | China | 510650 |
| 148 | Novo Nordisk Investigational Site | Shijiazhuang | Hebei | China | 50051 |
| 149 | Novo Nordisk Investigational Site | Nanjing | Jiangsu | China | 210003 |
| 150 | Novo Nordisk Investigational Site | Zhenjiang | Jiangsu | China | 212021 |
| 151 | Novo Nordisk Investigational Site | Changchun | Jilin | China | 130021 |
| 152 | Novo Nordisk Investigational Site | Yinchuan | Ningxia | China | 750004 |
| 153 | Novo Nordisk Investigational Site | Qingdao | Shandong | China | 266011 |
| 154 | Novo Nordisk Investigational Site | Shanghai | Shanghai | China | 200001 |
| 155 | Novo Nordisk Investigational Site | Shanghai | Shanghai | China | 200025 |
| 156 | Novo Nordisk Investigational Site | Shanghai | Shanghai | China | 201999 |
| 157 | Novo Nordisk Investigational Site | Tianjin | Tianjin | China | 300170 |
| 158 | Novo Nordisk Investigational Site | Beijing | China | 100050 | |
| 159 | Novo Nordisk Investigational Site | Osijek | Croatia | 31 000 | |
| 160 | Novo Nordisk Investigational Site | Rijeka | Croatia | 51000 | |
| 161 | Novo Nordisk Investigational Site | Zagreb | Croatia | 10000 | |
| 162 | Novo Nordisk Investigational Site | Liberec | Czechia | 460 63 | |
| 163 | Novo Nordisk Investigational Site | Prague 2 | Czechia | 128 08 | |
| 164 | Novo Nordisk Investigational Site | Aarhus N | Denmark | 8200 | |
| 165 | Novo Nordisk Investigational Site | Hvidovre | Denmark | 2650 | |
| 166 | Novo Nordisk Investigational Site | Angers | France | 49000 | |
| 167 | Novo Nordisk Investigational Site | Clichy | France | 92110 | |
| 168 | Novo Nordisk Investigational Site | Lille | France | 59037 | |
| 169 | Novo Nordisk Investigational Site | NICE cedex 3 | France | 06202 | |
| 170 | Novo Nordisk Investigational Site | Paris | France | 75014 | |
| 171 | Novo Nordisk Investigational Site | Paris | France | 75651 | |
| 172 | Novo Nordisk Investigational Site | Pessac | France | 33604 | |
| 173 | Novo Nordisk Investigational Site | Pierre Benite | France | 69310 | |
| 174 | Novo Nordisk Investigational Site | Strasbourg | France | 67098 | |
| 175 | Novo Nordisk Investigational Site | Berlin | Germany | 10825 | |
| 176 | Novo Nordisk Investigational Site | Berlin | Germany | 133553 | |
| 177 | Novo Nordisk Investigational Site | Bonn | Germany | 53127 | |
| 178 | Novo Nordisk Investigational Site | Frankfurt | Germany | 60590 | |
| 179 | Novo Nordisk Investigational Site | Hannover | Germany | 30625 | |
| 180 | Novo Nordisk Investigational Site | Leipzig | Germany | 04103 | |
| 181 | Novo Nordisk Investigational Site | Lübeck | Germany | 23562 | |
| 182 | Novo Nordisk Investigational Site | Mainz | Germany | 55131 | |
| 183 | Novo Nordisk Investigational Site | Würzburg | Germany | 97080 | |
| 184 | Novo Nordisk Investigational Site | Athens | Greece | GR-11527 | |
| 185 | Novo Nordisk Investigational Site | Athens | Greece | GR-11527 | |
| 186 | Novo Nordisk Investigational Site | Goudi, Athens | Greece | GR-115 27 | |
| 187 | Novo Nordisk Investigational Site | Ioannina | Greece | 45500 | |
| 188 | Novo Nordisk Investigational Site | Larissa | Greece | GR-41110 | |
| 189 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-54621 | |
| 190 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-54636 | |
| 191 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-54642 | |
| 192 | Novo Nordisk Investigational Site | Surat | Gujarat | India | 395001 |
| 193 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400012 |
| 194 | Novo Nordisk Investigational Site | Nagpur | Maharashtra | India | 440010 |
| 195 | Novo Nordisk Investigational Site | Delhi | New Delhi | India | 110029 |
| 196 | Novo Nordisk Investigational Site | Chandigarh | Punjab | India | 160012 |
| 197 | Novo Nordisk Investigational Site | Mohali | Punjab | India | 160062 |
| 198 | Novo Nordisk Investigational Site | Jaipur | Rajasthan | India | 302001 |
| 199 | Novo Nordisk Investigational Site | Jaipur | Rajasthan | India | 302004 |
| 200 | Novo Nordisk Investigational Site | Lucknow | Uttar Pradesh | India | 226003 |
| 201 | Novo Nordisk Investigational Site | Ludhiana | India | 141001 | |
| 202 | Novo Nordisk Investigational Site | New Delhi | India | 110070 | |
| 203 | Novo Nordisk Investigational Site | Dublin | Ireland | D08 NHY1 | |
| 204 | Novo Nordisk Investigational Site | Dublin | Ireland | D09V2N0 | |
| 205 | Novo Nordisk Investigational Site | Haifa | Israel | 3434104 | |
| 206 | Novo Nordisk Investigational Site | Jerusalem | Israel | 91031 | |
| 207 | Novo Nordisk Investigational Site | Jerusalem | Israel | ||
| 208 | Novo Nordisk Investigational Site | Petah-Tikva | Israel | 49100 | |
| 209 | Novo Nordisk Investigational Site | Ramat-Gan | Israel | 52621 | |
| 210 | Novo Nordisk Investigational Site | Tel Aviv | Israel | 64239 | |
| 211 | Novo Nordisk Investigational Site | Bologna | Italy | 40138 | |
| 212 | Novo Nordisk Investigational Site | Catanzaro | Italy | 88100 | |
| 213 | Novo Nordisk Investigational Site | Foggia | Italy | 71122 | |
| 214 | Novo Nordisk Investigational Site | Milano | Italy | 20122 | |
| 215 | Novo Nordisk Investigational Site | Palermo | Italy | 90127 | |
| 216 | Novo Nordisk Investigational Site | Rome | Italy | 00128 | |
| 217 | Novo Nordisk Investigational Site | Torino | Italy | 10126 | |
| 218 | Novo Nordisk Investigational Site | Bunkyo-ku, Tokyo | Japan | 113-8431 | |
| 219 | Novo Nordisk Investigational Site | Bunkyo-ku, Tokyo | Japan | 113-8655 | |
| 220 | Novo Nordisk Investigational Site | Fukui-shi, Fukui | Japan | 918-8503 | |
| 221 | Novo Nordisk Investigational Site | Hamamatsu-shi, Shizuoka | Japan | 431-3192 | |
| 222 | Novo Nordisk Investigational Site | Hatsukaichi-shi, Hiroshima | Japan | 783-8503 | |
| 223 | Novo Nordisk Investigational Site | Hiroshima-shi, Hiroshima | Japan | 730-8619 | |
| 224 | Novo Nordisk Investigational Site | Hiroshima-shi, Hiroshima | Japan | 734-8551 | |
| 225 | Novo Nordisk Investigational Site | Izunokuni-shi, Shizuoka | Japan | 410-2295 | |
| 226 | Novo Nordisk Investigational Site | Kagoshima-shi, Kagoshima | Japan | 890-8520 | |
| 227 | Novo Nordisk Investigational Site | Kamigyo-ku, Kyoto | Japan | 602-8566 | |
| 228 | Novo Nordisk Investigational Site | Kanazawa-shi, Ishikawa | Japan | 920-8641 | |
| 229 | Novo Nordisk Investigational Site | Kashihara-shi, Nara | Japan | 634-8522 | |
| 230 | Novo Nordisk Investigational Site | Kawasaki-shi, Kanagawa | Japan | 216-8511 | |
| 231 | Novo Nordisk Investigational Site | Kumamoto-shi, Kumamoto | Japan | 862-8655 | |
| 232 | Novo Nordisk Investigational Site | Minato-ku, Tokyo | Japan | 105-8470 | |
| 233 | Novo Nordisk Investigational Site | Musashino-shi, Tokyo | Japan | 180-8610 | |
| 234 | Novo Nordisk Investigational Site | Nagakute-shi, Aichi | Japan | 480-1195 | |
| 235 | Novo Nordisk Investigational Site | Nakagamigun, Okinawa | Japan | 901-2492 | |
| 236 | Novo Nordisk Investigational Site | Nara-shi, Nara | Japan | 630-8305 | |
| 237 | Novo Nordisk Investigational Site | Nishinomiya-shi, Hyogo | Japan | 663-8501 | |
| 238 | Novo Nordisk Investigational Site | Oita-shi, Oita | Japan | 870-0837 | |
| 239 | Novo Nordisk Investigational Site | Okayama-shi, Okayama | Japan | 700-8505 | |
| 240 | Novo Nordisk Investigational Site | Osaka-shi, Osaka | Japan | 545-8586 | |
| 241 | Novo Nordisk Investigational Site | Otsu-shi, Shiga | Japan | 520-0804 | |
| 242 | Novo Nordisk Investigational Site | Saga-shi, Saga | Japan | 849-8501 | |
| 243 | Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | Japan | 062-8618 | |
| 244 | Novo Nordisk Investigational Site | Sendai-shi, Miyagi | Japan | 980-0873 | |
| 245 | Novo Nordisk Investigational Site | Shinjuku-ku, Tokyo | Japan | 162-8666 | |
| 246 | Novo Nordisk Investigational Site | Suita-shi, Osaka | Japan | 564-0013 | |
| 247 | Novo Nordisk Investigational Site | Suita-shi, Osaka | Japan | 565-0871 | |
| 248 | Novo Nordisk Investigational Site | Takamatsu-shi, Kagawa | Japan | 760-8557 | |
| 249 | Novo Nordisk Investigational Site | Takasaki-shi, Gunma | Japan | 370-0829 | |
| 250 | Novo Nordisk Investigational Site | Tokyo | Japan | 173-8610 | |
| 251 | Novo Nordisk Investigational Site | Toon-shi, Ehime | Japan | 791-0295 | |
| 252 | Novo Nordisk Investigational Site | Wakayama-shi, Wakayama | Japan | 640-8158 | |
| 253 | Novo Nordisk Investigational Site | Yokohama-shi, Kanagawa | Japan | 236-0004 | |
| 254 | Novo Nordisk Investigational Site | Daegu | Korea, Republic of | 41944 | |
| 255 | Novo Nordisk Investigational Site | Daegu | Korea, Republic of | 42601 | |
| 256 | Novo Nordisk Investigational Site | Gangwon-do | Korea, Republic of | 26426 | |
| 257 | Novo Nordisk Investigational Site | Gyeonggi-do | Korea, Republic of | 14584 | |
| 258 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 03722 | |
| 259 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 06973 | |
| 260 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 07061 | |
| 261 | Novo Nordisk Investigational Site | Seoul | Korea, Republic of | 08308 | |
| 262 | Novo Nordisk Investigational Site | Batu Caves | Malaysia | 68100 | |
| 263 | Novo Nordisk Investigational Site | Kota Bharu, Kelantan | Malaysia | 16150 | |
| 264 | Novo Nordisk Investigational Site | Kuala Lumpur | Malaysia | 59100 | |
| 265 | Novo Nordisk Investigational Site | Acapulco de Juarez | Guerrero | Mexico | 39670 |
| 266 | Novo Nordisk Investigational Site | Guadalajara | Jalisco | Mexico | 44130 |
| 267 | Novo Nordisk Investigational Site | Ciudad de México | México, D.F. | Mexico | 06700 |
| 268 | Novo Nordisk Investigational Site | Monterrey | Nuevo León | Mexico | 64000 |
| 269 | Novo Nordisk Investigational Site | Merida | Yucatan | Mexico | 97070 |
| 270 | Novo Nordisk Investigational Site | Alkmaar | Netherlands | 1815 JD | |
| 271 | Novo Nordisk Investigational Site | Amsterdam | Netherlands | 1105 AZ | |
| 272 | Novo Nordisk Investigational Site | Leiden | Netherlands | 2333 ZA | |
| 273 | Novo Nordisk Investigational Site | Gjettum | Norway | 1346 | |
| 274 | Novo Nordisk Investigational Site | Oslo | Norway | 0450 | |
| 275 | Novo Nordisk Investigational Site | Bydgoszcz | Poland | 85-676 | |
| 276 | Novo Nordisk Investigational Site | Mysłowice | Poland | 41-400 | |
| 277 | Novo Nordisk Investigational Site | Wroclaw | Poland | 51-162 | |
| 278 | Novo Nordisk Investigational Site | Almada | Portugal | 2805-267 | |
| 279 | Novo Nordisk Investigational Site | Aveiro | Portugal | 3814-501 | |
| 280 | Novo Nordisk Investigational Site | Braga | Portugal | 4710-243 | |
| 281 | Novo Nordisk Investigational Site | Guarda | Portugal | 6300-035 | |
| 282 | Novo Nordisk Investigational Site | Guimarães | Portugal | 4835-044 | |
| 283 | Novo Nordisk Investigational Site | Lisboa | Portugal | 1649-035 | |
| 284 | Novo Nordisk Investigational Site | Matosinhos | Portugal | 4464-513 | |
| 285 | Novo Nordisk Investigational Site | Porto | Portugal | 4200-319 | |
| 286 | Novo Nordisk Investigational Site | Viana do Castelo | Portugal | 4901-858 | |
| 287 | Novo Nordisk Investigational Site | Vila Nova de Gaia | Portugal | 4400-346 | |
| 288 | Novo Nordisk Investigational Site | Vila Real | Portugal | 5000-508 | |
| 289 | Novo Nordisk Investigational Site | San Juan | Puerto Rico | 00927 | |
| 290 | Novo Nordisk Investigational Site | Bucharest | Romania | 011025 | |
| 291 | Novo Nordisk Investigational Site | Bucuresti | Romania | 022328 | |
| 292 | Novo Nordisk Investigational Site | Constanta | Romania | 900591 | |
| 293 | Novo Nordisk Investigational Site | Iasi | Romania | 700111 | |
| 294 | Novo Nordisk Investigational Site | Arkhangelsk | Russian Federation | 163001 | |
| 295 | Novo Nordisk Investigational Site | Barnaul | Russian Federation | 656045 | |
| 296 | Novo Nordisk Investigational Site | Kazan | Russian Federation | 420012 | |
| 297 | Novo Nordisk Investigational Site | Kazan | Russian Federation | 420111 | |
| 298 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 117292 | |
| 299 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 119435 | |
| 300 | Novo Nordisk Investigational Site | Novosibirsk | Russian Federation | 630099 | |
| 301 | Novo Nordisk Investigational Site | Penza | Russian Federation | 440026 | |
| 302 | Novo Nordisk Investigational Site | Saint Petersburg | Russian Federation | 190013 | |
| 303 | Novo Nordisk Investigational Site | Saint Petersburg | Russian Federation | 192283 | |
| 304 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 194156 | |
| 305 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 195067 | |
| 306 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 197110 | |
| 307 | Novo Nordisk Investigational Site | Tomsk | Russian Federation | 634050 | |
| 308 | Novo Nordisk Investigational Site | Ulianovsk | Russian Federation | 432063 | |
| 309 | Novo Nordisk Investigational Site | Yoshkar-Ola | Russian Federation | 424004 | |
| 310 | Novo Nordisk Investigational Site | Belgrade | Serbia | 11000 | |
| 311 | Novo Nordisk Investigational Site | Belgrade | Serbia | 11000 | |
| 312 | Novo Nordisk Investigational Site | Belgrade | Serbia | 11020 | |
| 313 | Novo Nordisk Investigational Site | Novi Sad | Serbia | 21000 | |
| 314 | Novo Nordisk Investigational Site | Bratislava | Slovakia | 833 05 | |
| 315 | Novo Nordisk Investigational Site | Bratislava | Slovakia | 851 01 | |
| 316 | Novo Nordisk Investigational Site | Trnava | Slovakia | 91701 | |
| 317 | Novo Nordisk Investigational Site | Port Elizabeth | Eastern Cape | South Africa | 6001 |
| 318 | Novo Nordisk Investigational Site | Johannesburg | Gauteng | South Africa | 2013 |
| 319 | Novo Nordisk Investigational Site | Lenasia | Gauteng | South Africa | 1827 |
| 320 | Novo Nordisk Investigational Site | Cape Town | South Africa | 7530 | |
| 321 | Novo Nordisk Investigational Site | Majadahonda | Spain | 28222 | |
| 322 | Novo Nordisk Investigational Site | Pontevedra | Spain | 36071 | |
| 323 | Novo Nordisk Investigational Site | Santander | Spain | 39008 | |
| 324 | Novo Nordisk Investigational Site | Sevilla | Spain | 41013 | |
| 325 | Novo Nordisk Investigational Site | Valencia | Spain | 46026 | |
| 326 | Novo Nordisk Investigational Site | Valladolid | Spain | 47010 | |
| 327 | Novo Nordisk Investigational Site | Bern | Switzerland | 3010 | |
| 328 | Novo Nordisk Investigational Site | Geneva | Switzerland | 1211 | |
| 329 | Novo Nordisk Investigational Site | Olten | Switzerland | 4600 | |
| 330 | Novo Nordisk Investigational Site | St. Gallen | Switzerland | 9007 | |
| 331 | Novo Nordisk Investigational Site | Zürich | Switzerland | 8091 | |
| 332 | Novo Nordisk Investigational Site | Chiayi City | Taiwan | 600 | |
| 333 | Novo Nordisk Investigational Site | Kaoshiung | Taiwan | 807 | |
| 334 | Novo Nordisk Investigational Site | Tainan City | Taiwan | 704 | |
| 335 | Novo Nordisk Investigational Site | Taipei city | Taiwan | 110 | |
| 336 | Novo Nordisk Investigational Site | Taipei city | Taiwan | 112 | |
| 337 | Novo Nordisk Investigational Site | Taipei | Taiwan | 100 | |
| 338 | Novo Nordisk Investigational Site | Taipei | Taiwan | 106 | |
| 339 | Novo Nordisk Investigational Site | Ankara | Turkey | 06230 | |
| 340 | Novo Nordisk Investigational Site | Ankara | Turkey | 06590 | |
| 341 | Novo Nordisk Investigational Site | Ankara | Turkey | 06800 | |
| 342 | Novo Nordisk Investigational Site | Bursa | Turkey | 16059 | |
| 343 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34010 | |
| 344 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34093 | |
| 345 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34093 | |
| 346 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34764 | |
| 347 | Novo Nordisk Investigational Site | Istanbul | Turkey | 34899 | |
| 348 | Novo Nordisk Investigational Site | Izmir | Turkey | 35100 | |
| 349 | Novo Nordisk Investigational Site | Kocaeli | Turkey | 41000 | |
| 350 | Novo Nordisk Investigational Site | Mersin | Turkey | 33343 | |
| 351 | Novo Nordisk Investigational Site | Belfast | United Kingdom | BT12 6BA | |
| 352 | Novo Nordisk Investigational Site | Birmingham | United Kingdom | B15 2TH | |
| 353 | Novo Nordisk Investigational Site | Coventry | United Kingdom | CV2 2DX | |
| 354 | Novo Nordisk Investigational Site | Derby | United Kingdom | DE22 3NE | |
| 355 | Novo Nordisk Investigational Site | Dundee | United Kingdom | DD1 9SY | |
| 356 | Novo Nordisk Investigational Site | Exeter | United Kingdom | EX2 5DW | |
| 357 | Novo Nordisk Investigational Site | Hull | United Kingdom | HU3 2GZ | |
| 358 | Novo Nordisk Investigational Site | Ipswich | United Kingdom | IP4 5RH | |
| 359 | Novo Nordisk Investigational Site | Leeds | United Kingdom | LS9 7TF | |
| 360 | Novo Nordisk Investigational Site | London | United Kingdom | E1 1FR | |
| 361 | Novo Nordisk Investigational Site | London | United Kingdom | NW3 2QG | |
| 362 | Novo Nordisk Investigational Site | London | United Kingdom | SE5 9RS | |
| 363 | Novo Nordisk Investigational Site | London | United Kingdom | W2 1NY | |
| 364 | Novo Nordisk Investigational Site | Newcastle-Upon Tyne | United Kingdom | NE7 7DN | |
| 365 | Novo Nordisk Investigational Site | Nottingham | United Kingdom | NG7 2UH | |
| 366 | Novo Nordisk Investigational Site | Oxford | United Kingdom | OX3 9DU | |
| 367 | Novo Nordisk Investigational Site | Plymouth | United Kingdom | PL6 8DH | |
| 368 | Novo Nordisk Investigational Site | Sheffield | United Kingdom | S5 7AU | |
| 369 | Novo Nordisk Investigational Site | Southampton | United Kingdom | SO16 6YD | |
| 370 | Novo Nordisk Investigational Site | Swansea | United Kingdom | SA2 8PP |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04822181
Other Study ID Numbers:
- NN9931-4553
- U1111-1244-3678
- 2019-004594-44
- jRCT2031210033
First Posted:
Mar 30, 2021
Last Update Posted:
Mar 11, 2022
Last Verified:
Feb 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: