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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1295-6713 | Other Identifier | World Health Organization (WHO) | |
| 2023-508170-28 | Other Identifier | European Medical Agency (EMA) |
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The study will look at the effects of NNC0194-0499, cagrilintide and semaglutide, on liver damage and alcohol use in participants with alcoholic liver disease. Participants will get NNC0194-0499, semaglutide, cagrilintide or ''dummy" medicine in different treatment combinations. Which treatment participants get is decided by chance. The study will last for about 39 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0194-0499 + semaglutide | Experimental | Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide. |
|
| NNC0194-0499 + semaglutide placebo | Experimental | Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide placebo. |
|
| NNC0194-0499 placebo + semaglutide | Experimental | Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide. |
|
| NNC0194-0499 placebo + semaglutide placebo | Placebo Comparator | Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide placebo. |
|
| CagriSema | Experimental | Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0194-0499 | Drug | Administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Enhanced Liver Fibrosis (ELF) | Measured as logarithm score | From week 0 to week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pro-peptide of Collagen 3 (Pro-C3) | Measured as ratio to baseline | From week 0 to week 28 |
| Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE) | Measured as ratio to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute for Liver Health | Chandler | Arizona | 85224 | United States | ||
| Arizona Liver Center |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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| Cagrilintide + semaglutide placebo | Experimental | Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide placebo. |
|
| Cagrilintide placebo + semaglutide placebo | Placebo Comparator | Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide placebo in combination with semaglutide placebo. |
|
| Semaglutide | Drug | Administered subcutaneously. |
|
| NNC0194-0499 placebo | Drug | Administered subcutaneously. |
|
| Semaglutide placebo (Group A) | Drug | Administered subcutaneously. |
|
| Cagrilintide + semaglutide | Drug | Administered subcutaneously. |
|
| Cagrilintide | Drug | Administered subcutaneously. |
|
| Cagrilintide placebo | Drug | Administered subcutaneously. |
|
| Semaglutide placebo (Group B) | Drug | Administered subcutaneously. |
|
| From week 0 to week 28 |
| Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP) | Measured as decibel milliwatts (dB/m) | From week 0 to week 28 |
| Change in Alanine Aminotransferase (ALT) | Measured as ratio to baseline | From week 0 to week 28 |
| Change in Aspartate Aminotransferase (AST) | Measured as ratio to baseline | From week 0 to week 28 |
| Number of treatment emergent adverse events | Measured as count of events | From week 0 to week 35 |
| Change in Phosphatidylethanol (PEth) | Measured as ratio to baseline | From week -4 to week 28 |
| Change in alcohol amount measured by timeline followback (TLFB) | Measured as grams per day | From week -4 to week 28 |
| Change in total cholesterol | Measured as ratio to baseline | From week 0 to week 28 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Del Sol Research Management, LLC | Tucson | Arizona | 85715 | United States |
| OM Research LLC | Lancaster | California | 93534 | United States |
| California Liver Research Institute | Pasadena | California | 91105 | United States |
| Covenant Metabolic Specialists LLC | Fort Myers | Florida | 33912 | United States |
| Miguel Rebollar PA | Hialeah | Florida | 33012 | United States |
| UF Hlth Jacksonville | Jacksonville | Florida | 32224 | United States |
| Univ of Miami/Schiff Ctr | Miami | Florida | 33136 | United States |
| Covenant Metabolic Specialists LLC | University Park | Florida | 34201 | United States |
| Rush University Med. Cntr | Chicago | Illinois | 60612 | United States |
| Kansas Medical Clinic, PA | Topeka | Kansas | 66606 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | United States |
| Boston Medical Center_Cary | Boston | Massachusetts | 02118 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | United States |
| Jubilee Clinical Research, Inc. | Las Vegas | Nevada | 89106 | United States |
| DSI Research,LLC | Springboro | Ohio | 45066 | United States |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC_Center for Liver Care | Pittsburgh | Pennsylvania | 15213 | United States |
| Digestive Health Research, TN | Hermitage | Tennessee | 37076 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| The Liver Institute | Dallas | Texas | 75203 | United States |
| South Texas Research Institute | Edinburg | Texas | 78539 | United States |
| Baylor St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| Houston Research Institute | Houston | Texas | 77079 | United States |
| Amer. Rrsch Corp-TX Liver Inst | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
| Liver Specialists of Texas | Sugar Land | Texas | 77479 | United States |
| Velocity Clinical Res, Waco | Waco | Texas | 76710 | United States |
| Momentum Clinical Research Darlinghurst | Darlinghurst | New South Wales | 2010 | Australia |
| Nepean Hospital | Kingswood | New South Wales | 2747 | Australia |
| St George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Westmead Hospital - Storr Liver Centre | Westmead | New South Wales | 2145 | Australia |
| Eastern Clinical Research Unit Box Hill | Box Hill | Victoria | 3128 | Australia |
| St Vincent's Hospital Melbourne - Gastroenterology Department | Fitzroy | Victoria | 3065 | Australia |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Fiona Stanley Hospital - Hepatology | Murdoch | Western Australia | 6150 | Australia |
| MHAT St. Ivan Rilski Gorna Oriahovitsa EOOD | Gorna Oryahovitsa | 5100 | Bulgaria |
| Acibadem City Clinic UMHAT Tokuda EAD, Gastroenterology | Sofia | 1407 | Bulgaria |
| UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases | Sofia | 1431 | Bulgaria |
| UMHAT Sveti Ivan Rilski EAD, Gastroenterology | Sofia | 1431 | Bulgaria |
| DCC XX - Sofia EOOD, Gastroenterology | Sofia | 1618 | Bulgaria |
| Medical Center Synexus Sofia EOOD | Sofia | 1784 | Bulgaria |
| University of Calgary Liver Unit-(HMRC) | Calgary | Alberta | T2N 4Z6 | Canada |
| GI Research Inst Foundation | Vancouver | British Columbia | V6Z 2K5 | Canada |
| London Health Sciences Centre- University Hospital | London | Ontario | N6A5A5 | Canada |
| TDDA Specialty Research | Vaughan | Ontario | L4L 4Y7 | Canada |
| Ctr de Med Metab de Lanaudiere | Terrebonne | Quebec | J6X 4P7 | Canada |
| Krajská nemocice Liberec, a.s | Liberec | 460 01 | Czechia |
| Vseobecna Fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Aalborg Universitetshospital | Aalborg | 9000 | Denmark |
| Herlev Hospital - Gastroenterology and Hepatology, Clinic 3 | Herlev | 2730 | Denmark |
| Hvidovre Hospital - Gastroenheden | Hvidovre | 2650 | Denmark |
| Odense University Hospital - FLASH - Centre for Liver Research | Odense C | 5000 | Denmark |
| Centre Hospitalier Universitaire D'Angers | Angers | 49100 | France |
| Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez | Lille | 59000 | France |
| Centre de Recherche Clinique Portes Du Sud | Vénissieux | 69200 | France |
| Universität des Saarlandes - Innere Med. II | Homburg | 66421 | Germany |
| Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH | Leipzig | 04103 | Germany |
| Universitätsklinikum Leipzig - Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie | Leipzig | 04103 | Germany |
| Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck | Lübeck | 23562 | Germany |
| Universitätsmedizin der JGU Mainz - Hepatologie | Mainz | 55131 | Germany |
| Universitätsklinikum Münster - Medizinische Klinik B | Münster | 48149 | Germany |
| Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM) | Würzburg | 97080 | Germany |
| University Hospital of Athens ATTIKON | Athens | Attica | 12462 | Greece |
| "Laiko" General Hospital of Athens | Goudi/Athens | 11527 | Greece |
| 'Ippokrateio' General Hospital of Thessaloniki | Thessaloniki | 54642 | Greece |
| AOU Careggi Firenze | Florence | Tuscany | 50134 | Italy |
| IRCCS Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| Fondazione Evangelica Betania - UO Epatologia | Naples | 80147 | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCS | Roma | 00168 | Italy |
| Juntendo University Hospital, Gastroenterology | Bunkyo-ku, Tokyo | 113-8431 | Japan |
| Juntendo University Hospital_Gastroenterology | Bunkyo-ku, Tokyo | 113-8431 | Japan |
| Akaicho Clinic | Chiba-shi, Chiba | 260-0804 | Japan |
| Ogaki Municipal Hospital_Gastroenterology and Hepatology | Gifu | 503-8502 | Japan |
| Naka Kinen Clinic_Internal medicine | Ibaraki | 311-0113 | Japan |
| Ishikawa Prefectural Central Hospital_Gastroenterology | Kanazawa-shi, Ishikawa | 920-8530 | Japan |
| Kumamoto Shinto General Hospital_Liver・Gastroenterology | Kumamoto-shi, Kumamoto | 862-8655 | Japan |
| Toranomon Hospital, Hepatology | Minato-ku, Tokyo | 105-8470 | Japan |
| Heartlife Hospital_Liver internal medicine | Nakagamigun, Okinawa | 901-2492 | Japan |
| Oita Cardiovascular Hospital_Gastroenterology | Oita-shi, Oita | 870-0837 | Japan |
| JCHO Hokkaido Hospital_Digestive Disease Center | Sapporo-shi, Hokkaido | 062-8618 | Japan |
| Saiseikai Suita Hospital, Gastroenterology | Suita-shi, Osaka | 564-0013 | Japan |
| Nihon University Itabashi Hospital_Division of Gastro.&Hepa. | Tokyo | 173-8610 | Japan |
| Albert Schweitzer Zkh, Dordwijk | Dordrecht | 3318 AT | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| ETZ Elisabeth | Tilburg | 5022 GC | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Centrum Medyczne Intercor Sp. z o.o. | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-605 | Poland |
| Gastromed Sp. z o.o. | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Krakow | Lesser Poland Voivodeship | 30-688 | Poland |
| ID Clinic Arkadiusz Pisula | Myslowice | Lesser Poland Voivodeship | 41-400 | Poland |
| PANSTWOWY INSTYTUT MEDYCZNY MSWiA | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Podlaskie Voivodeship | 15-540 | Poland |
| Sonomed Sp. Z O.O. | Szczecin | West Pomeranian Voivodeship | 71-685 | Poland |
| "LANDA" Katarzyna Agata Landa | Krakow | 31-156 | Poland |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Clinic i Provincial | Barcelona | Catalonia | 08036 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | España | 47003 | Spain |
| Complejo Hospitalario de Pontevedra - Hospital de Montecelo | Pontevedra | Galicia | 36004 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| ID | Term |
|---|---|
| C000591245 | semaglutide |
| C000717792 | cagrilintide |
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