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 (STARLIGHT)

March 27, 2026 updated by: GlaxoSmithKline

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

393

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Bandi
      • Buenos Aires, Argentina, C1061AAS
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernando Gruz
      • Buenos Aires, Argentina
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Anders
      • Buenos Aires, Argentina, 1425
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcela Paola Alicia De Sousa Coelho
      • Ciudad AutOnoma de Buenos Aire, Argentina, 1118
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nora Cejas
      • Ciudad Autonoma de Buenos Aire, Argentina, 1426
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matias Bori
      • Rosario, Argentina, S2002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Favareto
      • San Miguel de Tucumán, Argentina, T4000IHE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Palazzo
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edmund Tse
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • William Kemp
      • Parkville Melbourne, Victoria, Australia, 3050
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ashok Raj
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Oyekoya Ayonrinde
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tim Mitchell
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Henry Nguyen
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Steven Cheuk-Fung Pi
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alnoor Ramji
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammad Qasim Khan
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jordan Feld
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M1S 4T7
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gerald Chan
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julian Hercun
      • Terrebonne, Quebec, Canada, J6X 4P7
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yves Robitaille
  • Denmark
      • Esbjerg, Denmark, 6700
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mette Munk Lauridsen
      • Hvidovre, Denmark, 2650
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lise Lotte Gluud
        • Contact:
        • Contact:
      • Odense C, Denmark, 5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Camilla Hansen
  • France
      • Angers, France, 49933
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jérôme Boursier
        • Contact:
        • Contact:
      • Bobigny, France, 93000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nathalie Ganne-Carrie
      • Créteil, France, 94000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Philippe Richardet
      • Lille, France, 59037
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Philippe Mathurin
        • Contact:
        • Contact:
      • Montpellier, France, 34295
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • José URSIC BEDOYA
      • Rouen, France, 76031
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ghassan Riachi
  • Germany
      • Berlin, Germany, 10787
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Keikawus Arasteh
        • Contact:
        • Contact:
      • Berlin, Germany, 13353
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muenevver Demir
      • Kiel, Germany, 24105
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rainer Guenther
      • Leipzig, Germany, 04103
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ingolf Schiefke
      • Mainz, Germany, 55101
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Labenz
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44892
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isabell Hanitz
  • Greece
      • Athens, Greece, 10676
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vasileios Sevastianos
      • Athens, Greece, 11527
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • George Papatheodoridis
  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Stefano Fagiuoli
        • Contact:
        • Contact:
      • Bologna, Italy, 40138
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paolo Caraceni
        • Contact:
        • Contact:
      • Messina, Italy, 98124
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • irene cacciola
      • Milan, Italy, 20122
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Pietro Lampertico
        • Contact:
        • Contact:
      • Milan, Italy, 20142
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Crosignani
      • Milan, Italy, 20162
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giovanni Perricone
      • Padua, Italy, 35131
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrizia Burra
      • Roma, Italy, 00128
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Umberto Vespasiani Gentilucci
      • Roma, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giovanni Addolorato
  • Japan
      • Chiba, Japan, 286-8520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hirotoshi Ebinuma
      • Ehime, Japan, 790-0024
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hideko Ohama
      • Gunma, Japan, 371-8511
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Toshio Uraoka
        • Contact:
        • Contact:
      • Hokkaido, Japan, 060-0033
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomoaki Nakajima
      • Kagawa, Japan, 761-0793
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Asahiro Morishita
      • Kagawa, Japan, 760-0017
        • Withdrawn
        • GSK Investigational Site
      • Nara, Japan, 634-8522
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tadashi Namisaki
      • Niigata, Japan, 951-8520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Akira Sakamaki
      • Osaka, Japan, 545-8586
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kohei Kotani
      • Osaka, Japan, 565-0871
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takahiro Kodama
      • Osaka, Japan, 564-0013
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Toshihide Shima
        • Contact:
        • Contact:
      • Saitama, Japan, 350-0495
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Satoshi Mochida
      • Shizuoka, Japan, 431-3192
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazuhito Kawata
      • Tokyo, Japan, 180-8610
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroyuki Nakanishi
  • Mexico
      • DF, Mexico, 14080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ricardo Macias Rodriguez
      • Mexico City, Mexico, 11510
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Luis Perez- Hernandez
      • Monterrey, Mexico, 66260
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Carlos Alejandro Cortez Hernández
        • Contact:
        • Contact:
  • Poland
      • Katowice, Poland, 40-600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marek Olakowski
      • Mysłowice, Poland, 41-400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ewa Janczewska
      • Warsaw, Poland, 00-124
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adam Parfienczyk
  • South Africa
      • Johannesburg, South Africa, 2193
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bilal Bobat
  • South Korea
      • Ansan, South Korea, 15355
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Young Kul Jung
      • Bucheon-si, South Korea
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Young Seok Kim
        • Contact:
        • Contact:
      • Daegu, South Korea, 700-721
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Soo Young Park
        • Contact:
        • Contact:
      • Seoul, South Korea, 06351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wonseok Kang
      • Seoul, South Korea, 138-736
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Won-Mook Choi
      • Seoul, South Korea, 02447
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gi-Ae Kim
      • Seoul, South Korea, 07061
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Won Kim
        • Contact:
        • Contact:
      • Suwon Gyeonggi-do, South Korea, 442-723
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Doseon Song
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Montserrat Garcia Retortillo
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meritxell Ventura Cots
      • Barcelona, Spain, 08036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elisa Pose Méndez
      • León, Spain, 24071
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Jorquera Plaza
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Monica Barreales Valbuena
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Clemente Sánchez
      • Madrid, Spain, 28006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Caldas Alvarez
      • Santander, Spain, 39011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joaquin Cabezas
      • Seville, Spain, 41013
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Manuel Romero Gomez
        • Contact:
        • Contact:
      • Valencia, Spain, 46014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos Alventosa Mateu
      • Valladolid, Spain, 47003
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Rocio Aller De La Fuente
        • Contact:
        • Contact:
      • Vigo, Spain, 36071
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Juan Turnes Vazquez
        • Contact:
        • Contact:
  • Sweden
      • Stockholm, Sweden, SE-141 86
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hannes Hagstrom
      • Uppsala, Sweden, 751 85
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fredrik Rorsman
        • Contact:
        • Contact:
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cihan Yurdaydin
    • Sur
      • Diyarbakır, Sur, Turkey (Türkiye), 21280
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mustafa Kemal Celen
    • Yüreğir
      • Adana, Yüreğir, Turkey (Türkiye), 01230
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hilmi Erdem Sumbul
    • İzmit
      • Kocaeli, İzmit, Turkey (Türkiye), 41001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Altay Celebi
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • James Maurice
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michael Allison
        • Contact:
        • Contact:
      • Glasgow Strathclyde, United Kingdom, G51 4TF
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rachael Swann
      • Leeds West Yorkshire, United Kingdom, LS9 7TF
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Richard Parker
      • Liverpool, United Kingdom, L9 7AL
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Cyril Sieberhagen
        • Contact:
        • Contact:
      • London, United Kingdom, W2 1NY
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark Thursz
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gautam Mehta
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Timothy Hardy
      • Plymouth, United Kingdom, PL6 5FP
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ashwin Dhanda
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anita Kohli
        • Contact:
        • Contact:
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karn Wijarnpreecha
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fadi Deeb
    • California
      • Davis, California, United States, 95817
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vikrant Rachakonda
      • Los Angeles, California, United States, 90048
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hyunseok Kim
      • Los Angeles, California, United States, 90033
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Norah Terrault
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick Weston
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • William Sanchez
        • Contact:
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lance Stein
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raj Vuppalanchi
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shekhar Challa
        • Contact:
        • Contact:
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gary Reiss
        • Contact:
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Syed-Mohammed Jafri
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elliot Shin
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Priya Grewal
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hersh Shroff
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Srinivasan Dasarathy
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rajender Reddy
    • Texas
      • Arlington, Texas, United States, 76012
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Reem Ghalib
        • Contact:
        • Contact:
      • Austin, Texas, United States, 78757
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rohit Puskoor
      • Dallas, Texas, United States, 75235
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Kerr
      • Dallas, Texas, United States, 75203
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mangesh Pagadala
      • Georgetown, Texas, United States, 78626
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rohit Puskoor
      • McAllen, Texas, United States, 78503
        • Completed
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Eric Lawitz
        • Contact:
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amon Asgharpour
      • Richmond, Virginia, United States, 23249
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jasmohan Bajaj

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo will be administered
Experimental: GSK4532990 Dose 1
Drug: GSK4532990
GSK4532990 will be administered
Experimental: GSK4532990 Dose 2
Drug: GSK4532990
GSK4532990 will be administered
Experimental: GSK4532990 Dose 3
Drug: GSK4532990
GSK4532990 will be administered
Experimental: GSK4532990 Dose 4
Drug: GSK4532990
GSK4532990 will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to 8 weeks
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
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
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
Time Frame: Baseline (Day 1) and up to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of GSK4532990
Time Frame: Up to Day 4
Up to Day 4
Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990
Time Frame: Up to Day 4
Up to Day 4
Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990
Time Frame: Up to 24 hours
Up to 24 hours
Plasma half-life (t1/2) of GSK4532990
Time Frame: Up to Day 4
Up to Day 4
Apparent clearance (CL/F) of GSK4532990
Time Frame: Up to Day 4
Up to Day 4
Time to maximum concentration (tmax) of GSK4532990
Time Frame: Up to Day 4
Up to Day 4
Apparent terminal phase volume of distribution (Vz/F) of GSK4532990
Time Frame: Up to Day 4
Up to Day 4
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990
Time Frame: Up to Day 3
Up to Day 3
Maximum observed plasma concentration (Cmax) of GSK4532990
Time Frame: Up to Day 3
Up to Day 3
Change from baseline in serum AST at Week 52
Time Frame: Baseline (Day 1), and at Week 52
Baseline (Day 1), and at Week 52
Change from baseline in Enhanced Liver Fibrosis (ELF™) score at Week 52
Time Frame: Baseline (Day 1), and at Week 52
The ELF™ score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers, including tissue inhibitor of metalloproteinases-1 (TIMP-1), type III procollagen (PIIINP), and hyaluronic acid (HA). The ELF™ score is used as a prognostic marker for disease progression. ELF™ score will range between 4.5 to 14.7. A higher ELF™ score will predict worse prognosis
Baseline (Day 1), and at Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

August 2, 2027

Study Completion (Estimated)

March 7, 2028

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 222291
  • 2024-511596-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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