Recruiting
Phase 2

GSK4532990

Sponsor:

GlaxoSmithKline

Code:

NCT06613698

Conditions

Liver Diseases, Alcoholic

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

GSK4532990

Placebo

Study Details

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

Study ID

NCT06613698

Start date

Sep 27, 2024

Status verified date

Jul, 2026

Completion date

Mar 7, 2028

Anticipated

Primary completion date

Nov 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

393 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GSK4532990 Dose 1

experimental: GSK4532990 Dose 2

experimental: GSK4532990 Dose 3

experimental: GSK4532990 Dose 4

placebo comparator: Placebo

Interventions

GSK4532990

GSK4532990 will be administered

Placebo

Placebo will be administered

Primary outcome measure

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 8 weeks ]
  • Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests [ Time Frame: Up to 8 weeks ]
  • Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 52 (kiloPascal) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  • Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 52 [ Time Frame: Baseline (Day 1) and up to Week 52 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

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

Locations

GSK Investigational Site

Recruiting

Chandler, Arizona, United States, 85224

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Anita Kohli

GSK Investigational Site

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Moises Nevah Rubin

GSK Investigational Site

Recruiting

Tucson, Arizona, United States, 85712

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Aimee Bachelier

GSK Investigational Site

Recruiting

Tucson, Arizona, United States, 85715

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Fadi Deeb

GSK Investigational Site

Recruiting

Coronado, California, United States, 92118

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Tarek Hassanein

GSK Investigational Site

Recruiting

Lancaster, California, United States, 93534

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jatinder Pruthi

GSK Investigational Site

Recruiting

Los Angeles, California, United States, 90033

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Norah Terrault

GSK Investigational Site

Recruiting

Los Angeles, California, United States, 90048

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Hyunseok Kim

GSK Investigational Site

Recruiting

Pasadena, California, United States, 91105

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Edward Mena

GSK Investigational Site

Recruiting

Sacramento, California, United States, 95817

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Vikrant Rachakonda

GSK Investigational Site

Recruiting

Brandon, Florida, United States, 33511

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Patrick Weston

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33173

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Barbara Moscoso

GSK Investigational Site

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

William Sanchez

GSK Investigational Site

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Lance Stein

GSK Investigational Site

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Raj Vuppalanchi

GSK Investigational Site

Recruiting

Topeka, Kansas, United States, 66606

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Shekhar Challa

GSK Investigational Site

Recruiting

Marrero, Louisiana, United States, 70072

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Gary Reiss

GSK Investigational Site

Recruiting

Detroit, Michigan, United States, 48202

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Syed-Mohammed Jafri

GSK Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Elliot Shin

GSK Investigational Site

Recruiting

New York, New York, United States, 10029

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Frances Lee

GSK Investigational Site

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Hersh Shroff

GSK Investigational Site

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Srinivasan Dasarathy

GSK Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19014

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

K. Rajender Reddy

GSK Investigational Site

Recruiting

Hermitage, Tennessee, United States, 37076

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Donald Lazas Jr

GSK Investigational Site

Recruiting

Arlington, Texas, United States, 76012

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Reem Ghalib

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78757

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Rohit Puskoor

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75203

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mangesh Pagadala

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75390-8565

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Thomas Kerr

GSK Investigational Site

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Thomas Cotter

GSK Investigational Site

Recruiting

Georgetown, Texas, United States, 78626

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Rohit Puskoor

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78215

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Eric Lawitz

GSK Investigational Site

Recruiting

Richmond, Virginia, United States, 23219

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Amon Asgharpour

GSK Investigational Site

Recruiting

Richmond, Virginia, United States, 23249

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jasmohan Bajaj

GSK Investigational Site

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Henry Nguyen

GSK Investigational Site

Recruiting

New Westminster, British Columbia, Canada, V3L 3W4

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Steven Cheuk-Fung Pi

GSK Investigational Site

Recruiting

Vancouver, British Columbia, Canada, V6Z 2K5

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Alnoor Ramji

GSK Investigational Site

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mohammad Qasim Khan

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M1S 4T7

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Gerald Chan

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jordan Feld

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Julian Hercun

GSK Investigational Site

Recruiting

Terrebonne, Quebec, Canada, J6X 4P7

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Yves Robitaille

More Information

Sponsor

GlaxoSmithKline

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • GSK4532990
  • Alcohol-related liver disease
  • Steatohepatitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-08-03.