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RECRUITING

NCT06613698

PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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

Official title: A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults With Alcohol-related Liver Disease (ALD)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

393

Start Date

2024-09-27

Completion Date

2028-03-07

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Liver Diseases, Alcoholic

Interventions

DRUG

GSK4532990

GSK4532990 will be administered

DRUG

Placebo

Placebo will be administered

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).

Locations (131)

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Davis, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Brandon, Florida, United States

GSK Investigational Site

Miami Lakes, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Topeka, Kansas, United States

GSK Investigational Site

Marrero, Louisiana, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Chapel Hill, North Carolina, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Arlington, Texas, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Georgetown, Texas, United States

GSK Investigational Site

McAllen, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad AutOnoma de Buenos Aire, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

Adelaide, South Australia, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

Parkville Melbourne, Victoria, Australia

GSK Investigational Site

Murdoch, Western Australia, Australia

GSK Investigational Site

Perth, Western Australia, Australia

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

New Westminster, British Columbia, Canada

GSK Investigational Site

Vancouver, British Columbia, Canada

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Terrebonne, Quebec, Canada

GSK Investigational Site

Esbjerg, Denmark

GSK Investigational Site

Hvidovre, Denmark

GSK Investigational Site

Odense C, Denmark

GSK Investigational Site

Angers, France

GSK Investigational Site

Bobigny, France

GSK Investigational Site

Créteil, France

GSK Investigational Site

Lille, France

GSK Investigational Site

Montpellier, France

GSK Investigational Site

Rouen, France

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Kiel, Germany

GSK Investigational Site

Leipzig, Germany

GSK Investigational Site

Mainz, Germany

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Bergamo, Italy

GSK Investigational Site

Bologna, Italy

GSK Investigational Site

Messina, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Padova, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Ehime, Japan

GSK Investigational Site

Gunma, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Kagawa, Japan

GSK Investigational Site

Kagawa, Japan

GSK Investigational Site

Nara, Japan

GSK Investigational Site

Niigata, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Saitama, Japan

GSK Investigational Site

Shizuoka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

DF, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Monterrey, Mexico

GSK Investigational Site

Katowice, Poland

GSK Investigational Site

Mysłowice, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Johannesburg, South Africa

GSK Investigational Site

Ansan, South Korea

GSK Investigational Site

Bucheon-si, South Korea

GSK Investigational Site

Daegu, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Suwon Gyeonggi-do, South Korea

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

León, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Santander, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Valladolid, Spain

GSK Investigational Site

Vigo, Spain

GSK Investigational Site

Stockholm, Sweden

GSK Investigational Site

Uppsala, Sweden

GSK Investigational Site

Kocaeli, İzmit, Turkey (Türkiye)

GSK Investigational Site

Diyarbakır, Sur, Turkey (Türkiye)

GSK Investigational Site

Adana, Yüreğir, Turkey (Türkiye)

GSK Investigational Site

Istanbul, Turkey (Türkiye)

GSK Investigational Site

Bristol, United Kingdom

GSK Investigational Site

Cambridge, United Kingdom

GSK Investigational Site

Glasgow Strathclyde, United Kingdom

GSK Investigational Site

Leeds West Yorkshire, United Kingdom

GSK Investigational Site

Liverpool, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Middlesbrough, United Kingdom

GSK Investigational Site

Plymouth, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (131)