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

NCT06613698 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2222912024-511596-15
• Study Type: interventional
• Target: 393
• Locations: 18 countries
• Sites: 131

Brief Summary

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

Conditions

Liver Diseases, Alcoholic

Keywords

GSK4532990; Alcohol-related liver disease; Steatohepatitis

Outcome Measures

Primary Outcomes (4)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  Up to 8 weeks

• Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests

  Up to 8 weeks

• Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 52 (kiloPascal)

  Liver stiffness will be measured by vibration-controlled transient elastography (VCTE) using the FibroScan® device.

  Baseline (Day 1) and up to Week 52

• Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 52

  MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.

  Baseline (Day 1) and up to Week 52

Secondary Outcomes (11)

• Maximum plasma concentration (Cmax) of GSK4532990

  Up to Day 4

• Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990

  Up to Day 4

• Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990

  Up to 24 hours

• Plasma half-life (t1/2) of GSK4532990

  Up to Day 4

• Apparent clearance (CL/F) of GSK4532990

  Up to Day 4

Study Arms (5)

GSK4532990 Dose 1

EXPERIMENTAL

Drug: GSK4532990

GSK4532990 Dose 2

EXPERIMENTAL

Drug: GSK4532990

GSK4532990 Dose 3

EXPERIMENTAL

Drug: GSK4532990

GSK4532990 Dose 4

EXPERIMENTAL

Drug: GSK4532990

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GSK4532990 DRUG

GSK4532990 will be administered

GSK4532990 Dose 1; GSK4532990 Dose 2; GSK4532990 Dose 3; GSK4532990 Dose 4

Placebo DRUG

Placebo will be administered

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (131)

GSK Investigational Site

Chandler, Arizona, 85224, United States

RECRUITING

GSK Investigational Site

Phoenix, Arizona, 85006, United States

RECRUITING

GSK Investigational Site

Tucson, Arizona, 85715, United States

RECRUITING

GSK Investigational Site

Davis, California, 95817, United States

RECRUITING

GSK Investigational Site

Los Angeles, California, 90033, United States

RECRUITING

GSK Investigational Site

Los Angeles, California, 90048, United States

RECRUITING

GSK Investigational Site

Brandon, Florida, 33511, United States

RECRUITING

GSK Investigational Site

Miami Lakes, Florida, 33016, United States

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GSK Investigational Site

Atlanta, Georgia, 30309, United States

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GSK Investigational Site

Indianapolis, Indiana, 46202, United States

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GSK Investigational Site

Topeka, Kansas, 66606, United States

RECRUITING

GSK Investigational Site

Marrero, Louisiana, 70072, United States

RECRUITING

GSK Investigational Site

Detroit, Michigan, 48202, United States

RECRUITING

GSK Investigational Site

Las Vegas, Nevada, 89106, United States

RECRUITING

GSK Investigational Site

New York, New York, 10029, United States

RECRUITING

GSK Investigational Site

Chapel Hill, North Carolina, 27514, United States

RECRUITING

GSK Investigational Site

Cleveland, Ohio, 44195, United States

RECRUITING

GSK Investigational Site

Philadelphia, Pennsylvania, 19014, United States

RECRUITING

GSK Investigational Site

Arlington, Texas, 76012, United States

RECRUITING

GSK Investigational Site

Austin, Texas, 78757, United States

RECRUITING

GSK Investigational Site

Dallas, Texas, 75203, United States

RECRUITING

GSK Investigational Site

Dallas, Texas, 75235, United States

RECRUITING

GSK Investigational Site

Georgetown, Texas, 78626, United States

RECRUITING

GSK Investigational Site

McAllen, Texas, 78503, United States

COMPLETED

GSK Investigational Site

San Antonio, Texas, 78215, United States

RECRUITING

GSK Investigational Site

Richmond, Virginia, 23219, United States

RECRUITING

GSK Investigational Site

Richmond, Virginia, 23249, United States

RECRUITING

GSK Investigational Site

Buenos Aires, 1425, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, C1061AAS, Argentina

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GSK Investigational Site

Buenos Aires, C1181ACH, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, Argentina

RECRUITING

GSK Investigational Site

Ciudad AutOnoma de Buenos Aire, 1118, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aire, 1426, Argentina

RECRUITING

GSK Investigational Site

Rosario, S2002, Argentina

RECRUITING

GSK Investigational Site

San Miguel de Tucumán, T4000IHE, Argentina

RECRUITING

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

RECRUITING

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

RECRUITING

GSK Investigational Site

Parkville Melbourne, Victoria, 3050, Australia

RECRUITING

GSK Investigational Site

Murdoch, Western Australia, 6150, Australia

RECRUITING

GSK Investigational Site

Perth, Western Australia, 6000, Australia

RECRUITING

GSK Investigational Site

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

GSK Investigational Site

New Westminster, British Columbia, V3L 3W4, Canada

RECRUITING

GSK Investigational Site

Vancouver, British Columbia, V6Z 2K5, Canada

RECRUITING

GSK Investigational Site

London, Ontario, N6A 5A5, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M1S 4T7, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

GSK Investigational Site

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

GSK Investigational Site

Terrebonne, Quebec, J6X 4P7, Canada

RECRUITING

GSK Investigational Site

Esbjerg, 6700, Denmark

RECRUITING

GSK Investigational Site

Hvidovre, 2650, Denmark

RECRUITING

GSK Investigational Site

Odense C, 5000, Denmark

RECRUITING

GSK Investigational Site

Angers, 49933, France

RECRUITING

GSK Investigational Site

Bobigny, 93000, France

RECRUITING

GSK Investigational Site

Créteil, 94000, France

RECRUITING

GSK Investigational Site

Lille, 59037, France

RECRUITING

GSK Investigational Site

Montpellier, 34295, France

RECRUITING

GSK Investigational Site

Rouen, 76031, France

RECRUITING

GSK Investigational Site

Bochum, North Rhine-Westphalia, 44892, Germany

RECRUITING

GSK Investigational Site

Berlin, 10787, Germany

RECRUITING

GSK Investigational Site

Berlin, 13353, Germany

RECRUITING

GSK Investigational Site

Kiel, 24105, Germany

RECRUITING

GSK Investigational Site

Leipzig, 04103, Germany

RECRUITING

GSK Investigational Site

Mainz, 55101, Germany

RECRUITING

GSK Investigational Site

Athens, 10676, Greece

RECRUITING

GSK Investigational Site

Athens, 11527, Greece

RECRUITING

GSK Investigational Site

Athens, 11527, Greece

RECRUITING

GSK Investigational Site

Bergamo, 24127, Italy

RECRUITING

GSK Investigational Site

Bologna, 40138, Italy

RECRUITING

GSK Investigational Site

Messina, 98124, Italy

RECRUITING

GSK Investigational Site

Milan, 20122, Italy

RECRUITING

GSK Investigational Site

Milan, 20142, Italy

RECRUITING

GSK Investigational Site

Milan, 20162, Italy

RECRUITING

GSK Investigational Site

Padua, 35131, Italy

RECRUITING

GSK Investigational Site

Roma, 00128, Italy

RECRUITING

GSK Investigational Site

Roma, 00168, Italy

RECRUITING

GSK Investigational Site

Chiba, 286-8520, Japan

RECRUITING

GSK Investigational Site

Ehime, 790-0024, Japan

RECRUITING

GSK Investigational Site

Gunma, 371-8511, Japan

RECRUITING

GSK Investigational Site

Hokkaido, 060-0033, Japan

RECRUITING

GSK Investigational Site

Kagawa, 760-0017, Japan

WITHDRAWN

GSK Investigational Site

Kagawa, 761-0793, Japan

RECRUITING

GSK Investigational Site

Nara, 634-8522, Japan

RECRUITING

GSK Investigational Site

Niigata, 951-8520, Japan

RECRUITING

GSK Investigational Site

Osaka, 545-8586, Japan

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GSK Investigational Site

Osaka, 564-0013, Japan

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GSK Investigational Site

Osaka, 565-0871, Japan

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GSK Investigational Site

Saitama, 350-0495, Japan

RECRUITING

GSK Investigational Site

Shizuoka, 431-3192, Japan

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GSK Investigational Site

Tokyo, 180-8610, Japan

RECRUITING

GSK Investigational Site

DF, 14080, Mexico

RECRUITING

GSK Investigational Site

Mexico City, 11510, Mexico

RECRUITING

GSK Investigational Site

Monterrey, 66260, Mexico

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GSK Investigational Site

Katowice, 40-600, Poland

RECRUITING

GSK Investigational Site

Mysłowice, 41-400, Poland

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GSK Investigational Site

Warsaw, 00-124, Poland

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GSK Investigational Site

Johannesburg, 2193, South Africa

RECRUITING

GSK Investigational Site

Ansan, 15355, South Korea

RECRUITING

GSK Investigational Site

Bucheon-si, South Korea

RECRUITING

GSK Investigational Site

Daegu, 700-721, South Korea

RECRUITING

GSK Investigational Site

Seoul, 02447, South Korea

RECRUITING

GSK Investigational Site

Seoul, 06351, South Korea

RECRUITING

GSK Investigational Site

Seoul, 07061, South Korea

RECRUITING

GSK Investigational Site

Seoul, 138-736, South Korea

RECRUITING

GSK Investigational Site

Suwon Gyeonggi-do, 442-723, South Korea

RECRUITING

GSK Investigational Site

Barcelona, 08003, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08035, Spain

RECRUITING

GSK Investigational Site

Barcelona, 08036, Spain

RECRUITING

GSK Investigational Site

León, 24071, Spain

RECRUITING

GSK Investigational Site

Madrid, 28006, Spain

RECRUITING

GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28041, Spain

RECRUITING

GSK Investigational Site

Santander, 39011, Spain

RECRUITING

GSK Investigational Site

Seville, 41013, Spain

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GSK Investigational Site

Valencia, 46014, Spain

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GSK Investigational Site

Valladolid, 47003, Spain

RECRUITING

GSK Investigational Site

Vigo, 36071, Spain

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GSK Investigational Site

Stockholm, SE-141 86, Sweden

RECRUITING

GSK Investigational Site

Uppsala, 751 85, Sweden

RECRUITING

GSK Investigational Site

Kocaeli, İzmit, 41001, Turkey (Türkiye)

RECRUITING

GSK Investigational Site

Diyarbakır, Sur, 21280, Turkey (Türkiye)

RECRUITING

GSK Investigational Site

Adana, Yüreğir, 01230, Turkey (Türkiye)

RECRUITING

GSK Investigational Site

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

GSK Investigational Site

Bristol, BS10 5NB, United Kingdom

RECRUITING

GSK Investigational Site

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

GSK Investigational Site

Glasgow Strathclyde, G51 4TF, United Kingdom

RECRUITING

GSK Investigational Site

Leeds West Yorkshire, LS9 7TF, United Kingdom

RECRUITING

GSK Investigational Site

Liverpool, L9 7AL, United Kingdom

RECRUITING

GSK Investigational Site

London, NW3 2QG, United Kingdom

RECRUITING

GSK Investigational Site

London, W2 1NY, United Kingdom

RECRUITING

GSK Investigational Site

Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

GSK Investigational Site

Plymouth, PL6 5FP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Liver Diseases, Alcoholic; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): August 2, 2027
• Study Completion (Estimated): March 7, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

CA (8); ES (12); ME (3); AR (8); SE (2); GB (9); DE (6); GR (3); US (27); DK (3); TU (4); ZA (1); AU (5); FR (6); PL (3); JP (14); KR (8); IT (9)