Phase
Condition
Primary Biliary Cholangitis
Treatment
GSK4532990
Placebo
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Capable of giving signed informed consent prior to the performance of anystudy-specific procedures.
Able and willing to comply with all study assessments and adhere to the protocolschedule of activities.
In the opinion of the investigator, there is a history of alcohol consumptioncompatible with either ALD or Met ALD.
A female participant is eligible to participate after meeting additional pre-definedcriteria.
Participants must meet predefined stable use requirements of concomitant medicationsbased on study criteria.
Exclusion
Exclusion Criteria:
Meeting any definition of organ system failure as defined by the North AmericanConsortium for Study of End-stage Liver Disease (NACSELD)
Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT),Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets,International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c).Other primary causes of liver disease based on study criteria.
Current malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) atscreening. Participants under evaluation for possible malignancy at screening arenot eligible.
Prior organ transplant or current listing or active consideration for organtransplant during the screening period (except for corneal transplants).
Chronic or acute, including partial, known portal vein thrombosis.
Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.
Any acute cardiovascular event including myocardial infarction, unstable angina,symptomatic heart failure, or cerebrovascular accident in the 6 months prior toscreening.
Poorly controlled hypertension
Clinical suspicion of rhabdomyolysis during the screening period
Clinical suspicion of a bleeding episode during the screening period related toportal hypertension and/or low blood fibrinogen level.
Body Mass Index (BMI) >35 kg/m2 at screening
Any liver-related clinical event that started (onset) <8 weeks prior to Baseline (D1).
Study Design
Connect with a study center
GSK Investigational Site
Buenos Aires 3435910,
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire, 1118
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, 1426
ArgentinaActive - Recruiting
GSK Investigational Site
Rosario 3838583, S2002
ArgentinaActive - Recruiting
GSK Investigational Site
San Miguel de Tucumán 3836873, T4000IHE
ArgentinaActive - Recruiting
GSK Investigational Site
Adelaide, South Australia 5000
AustraliaSite Not Available
GSK Investigational Site
Adelaide 2078025, South Australia 2061327 5000
AustraliaActive - Recruiting
GSK Investigational Site
Melbourne 2158177, Victoria 2145234 3004
AustraliaActive - Recruiting
GSK Investigational Site
Parkville Melbourne, Victoria 2145234 3050
AustraliaActive - Recruiting
GSK Investigational Site
Murdoch, Western Australia 6150
AustraliaSite Not Available
GSK Investigational Site
Perth, Western Australia 6000
AustraliaSite Not Available
GSK Investigational Site
Murdoch 8349091, Western Australia 2058645 6150
AustraliaActive - Recruiting
GSK Investigational Site
Perth 2063523, Western Australia 2058645 6000
AustraliaActive - Recruiting
GSK Investigational Site
Melbourne, 3004
AustraliaSite Not Available
GSK Investigational Site
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
GSK Investigational Site
Calgary 5913490, Alberta 5883102 T2N 4Z6
CanadaActive - Recruiting
GSK Investigational Site
New Westminster, British Columbia V3L 3W4
CanadaSite Not Available
GSK Investigational Site
New Westminster 6087844, British Columbia 5909050 V3L 3W4
CanadaActive - Recruiting
GSK Investigational Site
Vancouver 6173331, British Columbia 5909050 V6Z 2K5
CanadaActive - Recruiting
GSK Investigational Site
London, Ontario N6A 5A5
CanadaSite Not Available
GSK Investigational Site
Toronto, Ontario M5G 2C4
CanadaSite Not Available
GSK Investigational Site
London 6058560, Ontario 6093943 N6A 5A5
CanadaActive - Recruiting
GSK Investigational Site
Toronto 6167865, Ontario 6093943 M5G 2C4
CanadaActive - Recruiting
GSK Investigational Site
Montreal, Quebec H2X 0A9
CanadaSite Not Available
GSK Investigational Site
Terrebonne, Quebec J6X 4P7
CanadaSite Not Available
GSK Investigational Site
Montreal 6077243, Quebec 6115047 H2X 0A9
CanadaActive - Recruiting
GSK Investigational Site
Terrebonne 6163012, Quebec 6115047 J6X 4P7
CanadaActive - Recruiting
GSK Investigational Site
Esbjerg,
DenmarkSite Not Available
GSK Investigational Site
Esbjerg 2622447, 6700
DenmarkActive - Recruiting
GSK Investigational Site
Hvidovre 2619528, 2650
DenmarkActive - Recruiting
GSK Investigational Site
Odense C, 5000
DenmarkSite Not Available
GSK Investigational Site
Odense C 11746507, 5000
DenmarkActive - Recruiting
GSK Investigational Site
Angers 3037656, 49933
FranceActive - Recruiting
GSK Investigational Site
Angers Cedex 9, 49933
FranceSite Not Available
GSK Investigational Site
Bobigny 3032179, 93000
FranceActive - Recruiting
GSK Investigational Site
Bobigny cedex, 93000
FranceSite Not Available
GSK Investigational Site
CrEteil Cedex, 94000
FranceSite Not Available
GSK Investigational Site
Créteil 3022530, 94000
FranceActive - Recruiting
GSK Investigational Site
Lille, 59037
FranceSite Not Available
GSK Investigational Site
Lille 2998324, 59037
FranceActive - Recruiting
GSK Investigational Site
Montpellier 2992166, 34295
FranceActive - Recruiting
GSK Investigational Site
Rouen 2982652, 76031
FranceActive - Recruiting
GSK Investigational Site
Rouen cedex, 76031
FranceSite Not Available
GSK Investigational Site
Bochum 2947416, North Rhine-Westphalia 2861876 44892
GermanyActive - Recruiting
GSK Investigational Site
Berlin, 10787
GermanySite Not Available
GSK Investigational Site
Berlin 2950159, 13353
GermanyActive - Recruiting
GSK Investigational Site
Kiel, 24105
GermanySite Not Available
GSK Investigational Site
Leipzig, 04103
GermanySite Not Available
GSK Investigational Site
Leipzig 2879139, 04103
GermanyActive - Recruiting
GSK Investigational Site
Mainz 2874225, 55101
GermanyActive - Recruiting
GSK Investigational Site
Bergamo, 24127
ItalySite Not Available
GSK Investigational Site
Bergamo 3182164, 24127
ItalyActive - Recruiting
GSK Investigational Site
Bologna, 40138
ItalySite Not Available
GSK Investigational Site
Bologna 3181928, 40138
ItalyActive - Recruiting
GSK Investigational Site
Messina, 98124
ItalySite Not Available
GSK Investigational Site
Messina 2524170, 98124
ItalyActive - Recruiting
GSK Investigational Site
Milan 6951411, 20122
ItalyActive - Recruiting
GSK Investigational Site
Milano, 20162
ItalySite Not Available
GSK Investigational Site
Padova, 35131
ItalySite Not Available
GSK Investigational Site
Padua 3171728, 35131
ItalyActive - Recruiting
GSK Investigational Site
Roma, 00128
ItalySite Not Available
GSK Investigational Site
Roma 8957247, 00128
ItalyActive - Recruiting
GSK Investigational Site
Chiba, 286-8520
JapanSite Not Available
GSK Investigational Site
Chiba 2113015, 286-8520
JapanActive - Recruiting
GSK Investigational Site
Ehime, 790-0024
JapanActive - Recruiting
GSK Investigational Site
Gunma, 371-8511
JapanActive - Recruiting
GSK Investigational Site
Hokkaido, 060-0033
JapanActive - Recruiting
GSK Investigational Site
Kagawa, 760-0017
JapanSite Not Available
GSK Investigational Site
Kagawa 1860837, 761-0793
JapanActive - Recruiting
GSK Investigational Site
Nara, 634-8522
JapanSite Not Available
GSK Investigational Site
Nara 1855612, 634-8522
JapanActive - Recruiting
GSK Investigational Site
Niigata 1855431, 951-8520
JapanActive - Recruiting
GSK Investigational Site
Osaka, 565-0871
JapanSite Not Available
GSK Investigational Site
Osaka 1853909, 564-0013
JapanActive - Recruiting
GSK Investigational Site
Saitama, 350-0495
JapanSite Not Available
GSK Investigational Site
Saitama 6940394, 350-0495
JapanActive - Recruiting
GSK Investigational Site
Shizuoka, 431-3192
JapanSite Not Available
GSK Investigational Site
Shizuoka 1851717, 431-3192
JapanActive - Recruiting
GSK Investigational Site
Tokyo, 180-8610
JapanSite Not Available
GSK Investigational Site
Tokyo 1850147, 180-8610
JapanActive - Recruiting
GSK Investigational Site
Ansan, 15355
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, 02447
Korea, Republic ofSite Not Available
GSK Investigational Site
Suwon Gyeonggi-do, 442-723
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Acapulgo, 39670
MexicoSite Not Available
GSK Investigational Site
Ciudad de Mexico, 11510
MexicoSite Not Available
GSK Investigational Site
DF, 14080
MexicoActive - Recruiting
GSK Investigational Site
Mexico City 3530597, 11510
MexicoActive - Recruiting
GSK Investigational Site
Monterrey 3995465, 66260
MexicoActive - Recruiting
GSK Investigational Site
Johannesburg 993800, 2193
South AfricaActive - Recruiting
GSK Investigational Site
Ansan 6807803, 15355
South KoreaActive - Recruiting
GSK Investigational Site
Bucheon-si 1838716,
South KoreaActive - Recruiting
GSK Investigational Site
Daegu 1835329, 700-721
South KoreaActive - Recruiting
GSK Investigational Site
Seoul 1835848, 02447
South KoreaActive - Recruiting
GSK Investigational Site
Suwon Gyeonggi-do, 442-723
South KoreaActive - Recruiting
GSK Investigational Site
Barcelona, 08036
SpainSite Not Available
GSK Investigational Site
Barcelona 3128760, 08003
SpainActive - Recruiting
GSK Investigational Site
Leon, 24071
SpainSite Not Available
GSK Investigational Site
León 3118532, 24071
SpainActive - Recruiting
GSK Investigational Site
Madrid, 28041
SpainSite Not Available
GSK Investigational Site
Madrid 3117735, 28041
SpainActive - Recruiting
GSK Investigational Site
Santander, 39011
SpainSite Not Available
GSK Investigational Site
Santander 3109718, 39011
SpainActive - Recruiting
GSK Investigational Site
Sevilla, 41013
SpainSite Not Available
GSK Investigational Site
Seville 2510911, 41013
SpainActive - Recruiting
GSK Investigational Site
Valencia, 46014
SpainSite Not Available
GSK Investigational Site
Valencia 2509954, 46014
SpainActive - Recruiting
GSK Investigational Site
Valladolid, 47003
SpainSite Not Available
GSK Investigational Site
Valladolid 3106672, 47003
SpainActive - Recruiting
GSK Investigational Site
Vigo 3105976, 36071
SpainActive - Recruiting
GSK Investigational Site
Stockholm, SE-141 86
SwedenSite Not Available
GSK Investigational Site
Stockholm 2673730, SE-141 86
SwedenActive - Recruiting
GSK Investigational Site
Uppsala, 753 09
SwedenSite Not Available
GSK Investigational Site
Uppsala 2666199, 751 85
SwedenActive - Recruiting
GSK Investigational Site
Istanbul, 34010
TurkeySite Not Available
GSK Investigational Site
Izmir, 35100
TurkeySite Not Available
GSK Investigational Site
Diyarbakır 316541, Sur 21280
Turkey (Türkiye)Active - Recruiting
GSK Investigational Site
Adana 325363, Yüreğir 01230
Turkey (Türkiye)Active - Recruiting
GSK Investigational Site
Kocaeli 306970, İzmit 41001
Turkey (Türkiye)Active - Recruiting
GSK Investigational Site
Istanbul 745044, 34010
Turkey (Türkiye)Active - Recruiting
GSK Investigational Site
Bristol 2654675, BS10 5NB
United KingdomActive - Recruiting
GSK Investigational Site
Cambridge 2653941, CB2 0QQ
United KingdomActive - Recruiting
GSK Investigational Site
Glasgow Strathclyde, G51 4TF
United KingdomActive - Recruiting
GSK Investigational Site
Leeds West Yorkshire, LS9 7TF
United KingdomActive - Recruiting
GSK Investigational Site
Liverpool, L9 7AL
United KingdomSite Not Available
GSK Investigational Site
Liverpool 2644210, L9 7AL
United KingdomActive - Recruiting
GSK Investigational Site
London, NW3 2QG
United KingdomSite Not Available
GSK Investigational Site
London 2643743, NW3 2QG
United KingdomActive - Recruiting
GSK Investigational Site
Middlesbrough, TS4 3BW
United KingdomSite Not Available
GSK Investigational Site
Middlesbrough 2642607, TS4 3BW
United KingdomActive - Recruiting
GSK Investigational Site
Plymouth 2640194, PL6 5FP
United KingdomActive - Recruiting
GSK Investigational Site
Chandler, Arizona 85224
United StatesSite Not Available
GSK Investigational Site
Phoenix, Arizona 85006
United StatesSite Not Available
GSK Investigational Site
Chandler 5289282, Arizona 5551752 85224
United StatesActive - Recruiting
GSK Investigational Site
Phoenix 5308655, Arizona 5551752 85006
United StatesActive - Recruiting
GSK Investigational Site
Tucson 5318313, Arizona 5551752 85715
United StatesActive - Recruiting
GSK Investigational Site
Los Angeles, California 90033
United StatesSite Not Available
GSK Investigational Site
Davis 5341704, California 5332921 95817
United StatesActive - Recruiting
GSK Investigational Site
Los Angeles 5368361, California 5332921 90048
United StatesActive - Recruiting
GSK Investigational Site
Brandon, Florida 33511
United StatesSite Not Available
GSK Investigational Site
Miami Lakes, Florida 33016
United StatesSite Not Available
GSK Investigational Site
Brandon 4148757, Florida 4155751 33511
United StatesActive - Recruiting
GSK Investigational Site
Miami Lakes 4164186, Florida 4155751 33016
United StatesActive - Recruiting
GSK Investigational Site
Atlanta 4180439, Georgia 4197000 30309
United StatesActive - Recruiting
GSK Investigational Site
Indianapolis, Indiana 46202
United StatesSite Not Available
GSK Investigational Site
Indianapolis 4259418, Indiana 4921868 46202
United StatesActive - Recruiting
GSK Investigational Site
Topeka 4280539, Kansas 4273857 66606
United StatesActive - Recruiting
GSK Investigational Site
Marrero, Louisiana 70072
United StatesSite Not Available
GSK Investigational Site
Marrero 4332628, Louisiana 4331987 70072
United StatesActive - Recruiting
GSK Investigational Site
Detroit, Michigan 48202
United StatesSite Not Available
GSK Investigational Site
Detroit 4990729, Michigan 5001836 48202
United StatesActive - Recruiting
GSK Investigational Site
Las Vegas 5506956, Nevada 5509151 89106
United StatesActive - Recruiting
GSK Investigational Site
New York, New York 10029
United StatesSite Not Available
GSK Investigational Site
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
GSK Investigational Site
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesActive - Recruiting
GSK Investigational Site
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
GSK Investigational Site
Philadelphia, Pennsylvania 19014
United StatesSite Not Available
GSK Investigational Site
Philadelphia 4560349, Pennsylvania 6254927 19014
United StatesActive - Recruiting
GSK Investigational Site
Dallas, Texas 75235
United StatesSite Not Available
GSK Investigational Site
McAllen, Texas 78503
United StatesSite Not Available
GSK Investigational Site
San Antonio, Texas 78215
United StatesSite Not Available
GSK Investigational Site
Arlington 4671240, Texas 4736286 76012
United StatesActive - Recruiting
GSK Investigational Site
Austin 4671654, Texas 4736286 78757
United StatesActive - Recruiting
GSK Investigational Site
Dallas 4684888, Texas 4736286 75235
United StatesActive - Recruiting
GSK Investigational Site
McAllen 4709796, Texas 4736286 78503
United StatesCompleted
GSK Investigational Site
San Antonio 4726206, Texas 4736286 78215
United StatesActive - Recruiting
GSK Investigational Site
Richmond, Virginia 23249
United StatesSite Not Available
GSK Investigational Site
Richmond 4781708, Virginia 6254928 23219
United StatesActive - Recruiting

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