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NCT06613698PHASE2Recruiting

A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease

GlaxoSmithKline

Start Date

9/27/2024

Completion Date

3/7/2028

Summary

The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.

Eligibility Criteria

Age Range: 18 years to 70 years

Inclusion Criteria: * Capable of giving signed informed consent prior to the performance of any study-specific procedures. * Able and willing to comply with all study assessments and adhere to the protocol schedule of activities. * In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD. * A female participant is eligible to participate after meeting additional pre-defined criteria. * Participants must meet predefined stable use requirements of concomitant medications based on study criteria. * Participant has advanced chronic liver disease Exclusion Criteria: * Meeting any definition of organ system failure as defined by the North American Consortium 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) at screening. Participants under evaluation for possible malignancy at screening are not eligible. * Prior organ transplant or current listing or active consideration for organ transplant 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 to screening. * Poorly controlled hypertension * Clinical suspicion of rhabdomyolysis during the screening period * Clinical suspicion of a bleeding episode during the screening period related to portal 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).

Interventions

DRUG

GSK4532990

DRUG

Placebo

Interested in This Trial?

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Conditions

Liver Diseases, Alcoholic

Locations

GSK Investigational Site

Chandler, Arizona 85224

United States

GSK Investigational Site

Phoenix, Arizona 85006

United States

GSK Investigational Site

Tucson, Arizona 85715

United States

GSK Investigational Site

Davis, California 95817

United States

GSK Investigational Site

Los Angeles, California 90033

United States

GSK Investigational Site

Los Angeles, California 90048

United States

GSK Investigational Site

Brandon, Florida 33511

United States

GSK Investigational Site

Miami Lakes, Florida 33016

United States

GSK Investigational Site

Atlanta, Georgia 30309

United States

GSK Investigational Site

Indianapolis, Indiana 46202

United States

GSK Investigational Site

Topeka, Kansas 66606

United States

GSK Investigational Site

Marrero, Louisiana 70072

United States

GSK Investigational Site

Detroit, Michigan 48202

United States

GSK Investigational Site

Las Vegas, Nevada 89106

United States

GSK Investigational Site

New York, New York 10029

United States

GSK Investigational Site

Chapel Hill, North Carolina 27514

United States

GSK Investigational Site

Cleveland, Ohio 44195

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19014

United States

GSK Investigational Site

Arlington, Texas 76012

United States

GSK Investigational Site

Austin, Texas 78757

United States

GSK Investigational Site

Dallas, Texas 75203

United States

GSK Investigational Site

Dallas, Texas 75235

United States

GSK Investigational Site

Georgetown, Texas 78626

United States

GSK Investigational Site

McAllen, Texas 78503

United States

GSK Investigational Site

San Antonio, Texas 78215

United States

GSK Investigational Site

Richmond, Virginia 23219

United States

GSK Investigational Site

Richmond, Virginia 23249

United States

GSK Investigational Site

Buenos Aires, 1425

Argentina

GSK Investigational Site

Buenos Aires, C1061AAS

Argentina

GSK Investigational Site

Buenos Aires, C1181ACH

Argentina

GSK Investigational Site

Buenos Aires,

Argentina

GSK Investigational Site

Ciudad AutOnoma de Buenos Aire, 1118

Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, 1426

Argentina

GSK Investigational Site

Rosario, S2002

Argentina

GSK Investigational Site

San Miguel de Tucumán, T4000IHE

Argentina

GSK Investigational Site

Adelaide, South Australia 5000

Australia

GSK Investigational Site

Melbourne, Victoria 3004

Australia

GSK Investigational Site

Parkville Melbourne, Victoria 3050

Australia

GSK Investigational Site

Murdoch, Western Australia 6150

Australia

GSK Investigational Site

Perth, Western Australia 6000

Australia

GSK Investigational Site

Calgary, Alberta T2N 4Z6

Canada

GSK Investigational Site

New Westminster, British Columbia V3L 3W4

Canada

GSK Investigational Site

Vancouver, British Columbia V6Z 2K5

Canada

GSK Investigational Site

London, Ontario N6A 5A5

Canada

GSK Investigational Site

Toronto, Ontario M1S 4T7

Canada

GSK Investigational Site

Toronto, Ontario M5G 2C4

Canada

GSK Investigational Site

Montreal, Quebec H2X 0A9

Canada

GSK Investigational Site

Terrebonne, Quebec J6X 4P7

Canada

GSK Investigational Site

Esbjerg, 6700

Denmark

GSK Investigational Site

Hvidovre, 2650

Denmark

GSK Investigational Site

Odense C, 5000

Denmark

GSK Investigational Site

Angers, 49933

France

GSK Investigational Site

Bobigny, 93000

France

GSK Investigational Site

Créteil, 94000

France

GSK Investigational Site

Lille, 59037

France

GSK Investigational Site

Montpellier, 34295

France

GSK Investigational Site

Rouen, 76031

France

GSK Investigational Site

Bochum, North Rhine-Westphalia 44892

Germany

GSK Investigational Site

Berlin, 10787

Germany

GSK Investigational Site

Berlin, 13353

Germany

GSK Investigational Site

Kiel, 24105

Germany

GSK Investigational Site

Leipzig, 04103

Germany

GSK Investigational Site

Mainz, 55101

Germany

GSK Investigational Site

Athens, 10676

Greece

GSK Investigational Site

Athens, 11527

Greece

GSK Investigational Site

Athens, 11527

Greece

GSK Investigational Site

Bergamo, 24127

Italy

GSK Investigational Site

Bologna, 40138

Italy

GSK Investigational Site

Messina, 98124

Italy

GSK Investigational Site

Milan, 20122

Italy

GSK Investigational Site

Milan, 20142

Italy

GSK Investigational Site

Milan, 20162

Italy

GSK Investigational Site

Padova, 35131

Italy

GSK Investigational Site

Roma, 00128

Italy

GSK Investigational Site

Roma, 00168

Italy

GSK Investigational Site

Chiba, 286-8520

Japan

GSK Investigational Site

Ehime, 790-0024

Japan

GSK Investigational Site

Gunma, 371-8511

Japan

GSK Investigational Site

Hokkaido, 060-0033

Japan

GSK Investigational Site

Kagawa, 760-0017

Japan

GSK Investigational Site

Kagawa, 761-0793

Japan

GSK Investigational Site

Nara, 634-8522

Japan

GSK Investigational Site

Niigata, 951-8520

Japan

GSK Investigational Site

Osaka, 545-8586

Japan

GSK Investigational Site

Osaka, 564-0013

Japan

GSK Investigational Site

Osaka, 565-0871

Japan

GSK Investigational Site

Saitama, 350-0495

Japan

GSK Investigational Site

Shizuoka, 431-3192

Japan

GSK Investigational Site

Tokyo, 180-8610

Japan

GSK Investigational Site

DF, 14080

Mexico

GSK Investigational Site

Mexico City, 11510

Mexico

GSK Investigational Site

Monterrey, 66260

Mexico

GSK Investigational Site

Katowice, 40-600

Poland

GSK Investigational Site

Mysłowice, 41-400

Poland

GSK Investigational Site

Warsaw, 00-124

Poland

GSK Investigational Site

Johannesburg, 2193

South Africa

GSK Investigational Site

Ansan, 15355

South Korea

GSK Investigational Site

Bucheon-si,

South Korea

GSK Investigational Site

Daegu, 700-721

South Korea

GSK Investigational Site

Seoul, 02447

South Korea

GSK Investigational Site

Seoul, 06351

South Korea

GSK Investigational Site

Seoul, 07061

South Korea

GSK Investigational Site

Seoul, 138-736

South Korea

GSK Investigational Site

Suwon Gyeonggi-do, 442-723

South Korea

GSK Investigational Site

Barcelona, 08003

Spain

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Barcelona, 08036

Spain

GSK Investigational Site

León, 24071

Spain

GSK Investigational Site

Madrid, 28006

Spain

GSK Investigational Site

Madrid, 28007

Spain

GSK Investigational Site

Madrid, 28041

Spain

GSK Investigational Site

Santander, 39011

Spain

GSK Investigational Site

Seville, 41013

Spain

GSK Investigational Site

Valencia, 46014

Spain

GSK Investigational Site

Valladolid, 47003

Spain

GSK Investigational Site

Vigo, 36071

Spain

GSK Investigational Site

Stockholm, SE-141 86

Sweden

GSK Investigational Site

Uppsala, 751 85

Sweden

GSK Investigational Site

Kocaeli, İzmit 41001

Turkey (Türkiye)

GSK Investigational Site

Diyarbakır, Sur 21280

Turkey (Türkiye)

GSK Investigational Site

Adana, Yüreğir 01230

Turkey (Türkiye)

GSK Investigational Site

Istanbul, 34010

Turkey (Türkiye)

GSK Investigational Site

Bristol, BS10 5NB

United Kingdom

GSK Investigational Site

Cambridge, CB2 0QQ

United Kingdom

GSK Investigational Site

Glasgow Strathclyde, G51 4TF

United Kingdom

GSK Investigational Site

Leeds West Yorkshire, LS9 7TF

United Kingdom

GSK Investigational Site

Liverpool, L9 7AL

United Kingdom

GSK Investigational Site

London, NW3 2QG

United Kingdom

GSK Investigational Site

London, W2 1NY

United Kingdom

GSK Investigational Site

Middlesbrough, TS4 3BW

United Kingdom

GSK Investigational Site

Plymouth, PL6 5FP

United Kingdom