Phase
Condition
Primary Biliary Cholangitis
Treatment
Cagrilintide + semaglutide
NNC0194-0499 placebo
Semaglutide placebo (Group A)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.
Age 18 years or above, and at the legal drinking age according to local requirementsat the time of signing the informed consent.
Patient-reported history of alcohol overuse for greater than or equal to 5 yearswith an alcohol history of a mean of greater than or equal to 50 grams (male)/40grams (female) pr day for the last year leading up to the time of signing informedconsent.
Enhanced Liver Fibrosis (ELF) greater than or equal to 9.0 units.
Exclusion
Exclusion Criteria:
Known or suspected hypersensitivity to study intervention(s) or related products (incl. excipients).
Previous participation (i.e., signed informed consent) in this study. If exclusioncriteria 7 is met (Vibration Controlled Transient Elastography liver stiffnessmeasurement (LSM) is greater than or equal to 25 Kilopascal (kPa)), a singlerescreening is possible at the investigator's discretion.
Documented causes of chronic liver disease other than Alcohol-related liver disease (ALD).
Positive hepatitis B surface antigen (HBsAg), positive human immunodeficiencyvirus-1 (HIV-1) or HIV-2 antibody (Ab), positive hepatitis C virus (HCV) ribonucleicacid (RNA) at screening (V1) or any known presence of HCV RNA or HBsAg within 2years of screening visit 1 (V1).
Presence or history of ascites more than grade 1, variceal bleeding, hepaticencephalopathy, spontaneous bacterial peritonitis, or liver transplantation atscreening (V1).
Alcohol hepatitis at randomisation (as defined by National Institute on AlcoholAbuse and Alcoholism (NIAAA)).
Vibration Controlled Transient Elastography liver stiffness measurement (LSM)greater than or equal to 25 kPa at visit 2 (V2). If participants meet thiscriterion, rescreening is allowed once.
Presence or history of gastro-oesophageal varices greater than or equal to grade 2*at V2. For participants with LSM greater than or equal to 20 kPa as well as bloodplatelets count less than 150,000 per microliter (μL) of blood anoesophagogastroduodenoscopy performed no more than 52 weeks prior to V2 must beavailable at V2. *Grade 2: varices projecting by one-third of the luminal diameterthat cannot be compressed with air insufflation4.
Body mass index (BMI) less than or equal to 25 Kilogram Per Square Meter (kg/m^2).
Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using highly effective contraceptive method with lowuser-dependency.
Study Design
Connect with a study center
Holdsworth House Clinical Research
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Nepean Hospital
Kingswood, New South Wales 2747
AustraliaSite Not Available
St George Hospital
Kogarah, New South Wales 2217
AustraliaActive - Recruiting
Westmead Hospital
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Eastern Clinical Research Unit Box Hill
Box Hill, Victoria 3128
AustraliaActive - Recruiting
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Austin Health
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Fiona Stanley Hospital - Hepatology
Murdoch, Western Australia 6150
AustraliaActive - Recruiting
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Gorna Oryahovitsa, 5100
BulgariaActive - Recruiting
"Acibadem City Clinic MHAT Tokuda"
Sofia, 1407
BulgariaSite Not Available
"Acibadem City Clinic UMHAT Tokuda"
Sofia, 1407
BulgariaActive - Recruiting
"DCC XX - Sofia" EOOD
Sofia, 1618
BulgariaActive - Recruiting
Medical Center Synexus Sofia
Sofia, 1784
BulgariaActive - Recruiting
UMHAT "Sv. Ivan Rilski", Clinic of Gastroenterology
Sofia, 1431
BulgariaActive - Recruiting
UMHAT Aleksandrovska
Sofia, 1431
BulgariaSite Not Available
University of Calgary Liver Unit-(HMRC)
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
GI Research Inst Foundation
Vancouver, British Columbia V6Z 2K5
CanadaActive - Recruiting
GI Research Institute
Vancouver, British Columbia V6Z 2K5
CanadaSite Not Available
London Health Sciences Centre- University Hospital
London, Ontario N6A5A5
CanadaActive - Recruiting
TDDA Specialty Research
Vaughan, Ontario L4L 4Y7
CanadaActive - Recruiting
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec J6X 4P7
CanadaActive - Recruiting
Krajská nemocice Liberec, a.s
Liberec, 460 01
CzechiaActive - Recruiting
Vseobecna Fakultni nemocnice v Praze
Prague 2, 128 08
CzechiaActive - Recruiting
Aalborg Universitetshospital
Aalborg, 9000
DenmarkActive - Recruiting
Herlev Hospital
Herlev, 2730
DenmarkActive - Recruiting
Hvidovre Hospital
Hvidovre, 2650
DenmarkActive - Recruiting
Hvidovre Hospital - Gastroenheden
Hvidovre, 2650
DenmarkActive - Recruiting
Odense University Hospital
Odense C, 5000
DenmarkActive - Recruiting
Centre Hospitalier Universitaire D'Angers-1
Angers, 49100
FranceActive - Recruiting
Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez
Lille, 59000
FranceActive - Recruiting
Centre de Recherche Clinique Portes Du Sud
Venissieux, 69200
FranceActive - Recruiting
Groupe Hospitalier Mutualiste Des Portes Du Sud
Venissieux, 69200
FranceSite Not Available
Universitätsklinikum des Saarlandes - Klinik für Innere Medizin II
Homburg, 66421
GermanySite Not Available
Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH
Leipzig, 04103
GermanySite Not Available
Universitätsklinikum Leipzig - Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Leipzig, 04103
GermanyActive - Recruiting
Universitätsklinikum Leipzig, Klinik und Poliklinik
Leipzig, 04103
GermanyActive - Recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck, 23562
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
Lübeck, 23562
GermanySite Not Available
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
Mainz, 55131
GermanySite Not Available
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz - Hepatologie
Mainz, 55131
GermanySite Not Available
Universitätsklinikum Münster - Medizinische Klinik B
Münster, 48149
GermanySite Not Available
Universitätsklinikum Würzburg, ZIM
Würzburg, 97080
GermanySite Not Available
Universitätsklinikum Würzburg, Zentrum für Innere Medizin (ZIM)
Würzburg, 97080
GermanySite Not Available
University Hospital of Athens ATTIKON
Athens, Attica 12462
GreeceActive - Recruiting
University Hospital of Athens ATTIKON
Haidari-Athens, Attica GR-12462
GreeceSite Not Available
"Laiko" General Hospital of Athens
Goudi/Athens, 11527
GreeceActive - Recruiting
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, 54642
GreeceActive - Recruiting
AOU Careggi Firenze
Firenze, Toscana 50134
ItalySite Not Available
IRCCS Azienda Ospedaliero Universitaria San Martino - IST
Genova, 16132
ItalySite Not Available
Ospedale Evangelico Betania
Naples, 80147
ItalySite Not Available
Azienda Ospedaliera di Padova
Padova, 35128
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
ItalySite Not Available
Juntendo University Hospital, Gastroenterology
Bunkyo-ku, Tokyo, 113-8431
JapanActive - Recruiting
Akaicho Clinic
Chiba-shi, Chiba, 260-0804
JapanActive - Recruiting
Ogaki Municipal Hospital_Gastroenterology and Hepatology
Gifu, 503-8502
JapanActive - Recruiting
Naka Kinen Clinic
Ibaraki, 311-0113
JapanSite Not Available
Ishikawa Prefectural Central Hospital_Gastroenterology
Kanazawa-shi, Ishikawa, 920-8530
JapanActive - Recruiting
Kumamoto Shinto General Hospital
Kumamoto-shi, Kumamoto, 862-8655
JapanActive - Recruiting
Toranomon Hospital, Hepatology
Minato-ku, Tokyo, 105-8470
JapanSite Not Available
Heartlife Hospital
Nakagamigun, Okinawa, 901-2492
JapanActive - Recruiting
Oita Cardiovascular Hospital
Oita-shi, Oita, 870-0837
JapanSite Not Available
Japan Community Health care Organization Hokkaido Hospital
Sapporo-shi, Hokkaido, 062-8618
JapanSite Not Available
Saiseikai Suita Hospital, Gastroenterology
Suita-shi, Osaka, 564-0013
JapanActive - Recruiting
Nihon University Itabashi Hospital
Tokyo, 173-8610
JapanActive - Recruiting
Albert Schweitzer Ziekenhuis locatie Dordwijk
Dordrecht, 3318 AT
NetherlandsActive - Recruiting
Erasmus MC
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
ETZ Elisabeth
Tilburg, 5022 GC
NetherlandsActive - Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
NetherlandsActive - Recruiting
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, Kujawsko-Pomorskie 85-605
PolandActive - Recruiting
Gastromed Sp. z o.o.
Toruń, Kujawsko-pomorskie 87-100
PolandActive - Recruiting
ID Clinic Arkadiusz Pisula
Mysłowice, Malopolskie 41-400
PolandActive - Recruiting
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warszawa, Mazowieckie 02-507
PolandActive - Recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital w Krakowie
Kraków, Małopolskie 30-688
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
Białystok, Podlaskie 15-540
PolandSite Not Available
Sonomed Sp. Z O.O.
Szczecin, Zachodniopomorskie 71-685
PolandActive - Recruiting
"LANDA" Katarzyna Agata Landa
Kraków, 31-156
PolandActive - Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria 39008
SpainActive - Recruiting
Hospital Clinic i Provincial
Barcelona, Cataluña 08036
SpainActive - Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, España 47003
SpainActive - Recruiting
Complejo Hospitalario de Pontevedra - Hospital de Montecelo
Pontevedra, Galicia 36004
SpainActive - Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
The Institute for Liver Health
Chandler, Arizona 85224
United StatesActive - Recruiting
Arizona Liver Center
Tucson, Arizona 85712
United StatesActive - Recruiting
Del Sol Research Management, LLC
Tucson, Arizona 85715
United StatesActive - Recruiting
OM Research LLC
Lancaster, California 93534
United StatesActive - Recruiting
California Liver Research Institute
Pasadena, California 91105
United StatesActive - Recruiting
Covenant Metabolic Specialists LLC
Fort Myers, Florida 33912
United StatesActive - Recruiting
Miguel Rebollar PA
Hialeah, Florida 33012
United StatesActive - Recruiting
UF Hepatology Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
UF Hlth Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
Univ of Miami/Schiff Ctr
Miami, Florida 33136
United StatesActive - Recruiting
Covenant Metabolic Specialists LLC
Sarasota, Florida 34240
United StatesSite Not Available
Covenant Metabolic Specialists LLC
University Park, Florida 34201
United StatesActive - Recruiting
Rush University Med. Cntr
Chicago, Illinois 60612
United StatesActive - Recruiting
Kansas Medical Clinic, PA
Topeka, Kansas 66606
United StatesActive - Recruiting
Louisiana Research Center, LLC
Shreveport, Louisiana 71105
United StatesSite Not Available
Boston Medical Center_Cary
Boston, Massachusetts 02118
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55902
United StatesActive - Recruiting
Jubilee Clinical Research, Inc.
Las Vegas, Nevada 89106
United StatesActive - Recruiting
DSI Research,LLC
Springboro, Ohio 45066
United StatesActive - Recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
UPMC_Center for Liver Care
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Digestive Health Research, TN
Hermitage, Tennessee 37076
United StatesActive - Recruiting
Texas Clinical Research Institute
Arlington, Texas 76012
United StatesActive - Recruiting
The Liver Institute
Dallas, Texas 75203
United StatesActive - Recruiting
South Texas Research Institute
Edinburg, Texas 78539
United StatesActive - Recruiting
Baylor St. Luke's Medical Center
Houston, Texas 77030
United StatesActive - Recruiting
Houston Research Institute
Houston, Texas 77079
United StatesActive - Recruiting
Liver Specialists of Texas
Houston, Texas 77030
United StatesSite Not Available
Amer. Rrsch Corp-TX Liver Inst
San Antonio, Texas 78215
United StatesActive - Recruiting
Pinnacle Clinical Research
San Antonio, Texas 78229
United StatesActive - Recruiting
Liver Specialists of Texas
Sugar Land, Texas 77479
United StatesSite Not Available
Velocity Clinical Res, Waco
Waco, Texas 76710
United StatesActive - Recruiting
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