Liver Diseases, AlcoholicPhase 2STARLIGHTNCT06613698

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

A Phase 2 study testing GSK4532990 in people with Liver Diseases, Alcoholic, run by GlaxoSmithKline at 140 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Liver Diseases, Alcoholic
What is being tested?: GSK4532990
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 393 participants
Where: 140 sitesin 18 countries
Study dates: 27 Sep 2024to 7 Mar 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 12Show fewer

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).

Trial locations and contacts

140 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

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

Country

City, postcode or hospital

Sites recruiting now only

140 sites in 18 countries

United States34 sites, 33 recruiting

GSK Investigational Site
Arlington, Texas, 76012
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Atlanta, Georgia, 30309
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Austin, Texas, 78757
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Brandon, Florida, 33511
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Chandler, Arizona, 85224
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Chapel Hill, North Carolina, 27514
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Cleveland, Ohio, 44195
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Coronado, California, 92118
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Dallas, Texas, 75203
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Dallas, Texas, 75390-8565
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Detroit, Michigan, 48202
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Fort Worth, Texas, 76104
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Georgetown, Texas, 78626
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Hermitage, Tennessee, 37076
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Indianapolis, Indiana, 46202
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Lancaster, California, 93534
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Las Vegas, Nevada, 89106
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Los Angeles, California, 90033
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Los Angeles, California, 90048
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Marrero, Louisiana, 70072
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
McAllen, Texas, 78503
Completed
GSK Investigational Site
Miami, Florida, 33173
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Miami Lakes, Florida, 33016
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
New York, New York, 10029
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Pasadena, California, 91105
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Philadelphia, Pennsylvania, 19014
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Phoenix, Arizona, 85006
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Richmond, Virginia, 23219
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Richmond, Virginia, 23249
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Sacramento, California, 95817
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
San Antonio, Texas, 78215
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Topeka, Kansas, 66606
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Tucson, Arizona, 85712
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Tucson, Arizona, 85715
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in United States

Japan14 sites, 13 recruiting

GSK Investigational Site
Chiba, 286-8520
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Ehime, 790-0024
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Gunma, 371-8511
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Hokkaido, 060-0033
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Kagawa, 760-0017
Withdrawn
GSK Investigational Site
Kagawa, 761-0793
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Nara, 634-8522
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Niigata, 951-8520
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Osaka, 545-8586
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Osaka, 564-0013
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Osaka, 565-0871
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Saitama, 350-0495
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Shizuoka, 431-3192
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Tokyo, 180-8610
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Japan

Spain12 sites, 12 recruiting

GSK Investigational Site
Barcelona, 08003
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Barcelona, 08035
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Barcelona, 08036
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
León, 24071
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Madrid, 28006
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Madrid, 28007
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Madrid, 28041
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Santander, 39011
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Seville, 41013
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Valencia, 46014
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Valladolid, 47003
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Vigo, 36071
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Spain

Argentina9 sites, 9 recruiting

GSK Investigational Site
Buenos Aires, 1425
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Buenos Aires, C1061AAS
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Buenos Aires, C1181ACH
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Buenos Aires
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, C1426
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire, 1118
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Rosario, 2002
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Rosario, S2002
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
San Miguel de Tucumán, T4000IHE
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Argentina

Italy9 sites, 9 recruiting

GSK Investigational Site
Bergamo, 24127
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Bologna, 40138
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Messina, 98124
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Milan, 20122
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Milan, 20142
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Milan, 20162
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Padova, 35131
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Roma, 00128
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Roma, 00168
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Italy

United Kingdom9 sites, 9 recruiting

GSK Investigational Site
Bristol, BS10 5NB
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Cambridge, CB2 0QQ
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Glasgow Strathclyde, G51 4TF
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Leeds West Yorkshire, LS9 7TF
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Liverpool, L9 7AL
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
London, NW3 2QG
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
London, W2 1NY
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Middlesbrough, TS4 3BW
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Plymouth, PL6 5FP
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in United Kingdom

Canada8 sites, 8 recruiting

GSK Investigational Site
Calgary, Alberta, T2N 4Z6
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
London, Ontario, N6A 5A5
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Montreal, Quebec, H2X 0A9
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
New Westminster, British Columbia, V3L 3W4
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Terrebonne, Quebec, J6X 4P7
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Toronto, Ontario, M1S 4T7
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Toronto, Ontario, M5G 2C4
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Vancouver, British Columbia, V6Z 2K5
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Canada

South Korea8 sites, 8 recruiting

GSK Investigational Site
Ansan, 15355
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Bucheon-si
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Daegu, 700-721
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Seoul, 02447
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Seoul, 06351
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Seoul, 07061
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Seoul, 138-736
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Suwon Gyeonggi-do, 442-723
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in South Korea

France6 sites, 6 recruiting

GSK Investigational Site
Angers, 49933
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Bobigny, 93000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Créteil, 94000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Lille, 59037
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Montpellier, 34295
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Rouen, 76031
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in France

Germany6 sites, 6 recruiting

GSK Investigational Site
Berlin, 10787
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Berlin, 13353
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44892
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Kiel, 24105
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Leipzig, 04103
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Mainz, 55101
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Germany

Australia5 sites, 5 recruiting

GSK Investigational Site
Adelaide, South Australia, 5000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Melbourne, Victoria, 3004
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Murdoch, Western Australia, 6150
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Parkville Melbourne, Victoria, 3050
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Perth, Western Australia, 6000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Australia

Turkey (Türkiye)4 sites, 4 recruiting

GSK Investigational Site
Adana, Yüreğir, 01230
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Diyarbakır, Sur, 21280
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Istanbul, 34010
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Kocaeli, İzmit, 41001
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Turkey (Türkiye)

Denmark3 sites, 3 recruiting

GSK Investigational Site
Esbjerg, 6700
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Hvidovre, 2650
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Odense C, 5000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Denmark

Greece3 sites, 3 recruiting

GSK Investigational Site
Athens, 10676
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Athens, 11527
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Athens, 11527
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Greece

Mexico3 sites, 3 recruiting

GSK Investigational Site
DF, 14080
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Mexico City, 11510
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
San Pedro Garza García, 66260
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Mexico

Poland3 sites, 3 recruiting

GSK Investigational Site
Katowice, 40-600
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Mysłowice, 41-400
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Warsaw, 00-124
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Poland

South Africa2 sites, 2 recruiting

GSK Investigational Site
Johannesburg, 2193
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Soweto Johannesburg, 2013
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in South Africa

Sweden2 sites, 2 recruiting

GSK Investigational Site
Stockholm, SE-141 86
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Uppsala, 751 85
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Sweden

About this study

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)

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
Being tested: GSK4532990, Placebo
Keywords: GSK4532990, Alcohol-related liver disease, Steatohepatitis
Medical subject headings: Liver Diseases, Alcoholic, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK4532990Drug
GSK4532990 will be administered
PlaceboDrug
Placebo will be administered

Study groups in NCT06613698
Study group	Role	What they receive
GSK4532990 Dose 1	Experimental	Not described Receives: Drug: GSK4532990
GSK4532990 Dose 2	Experimental	Not described Receives: Drug: GSK4532990
GSK4532990 Dose 3	Experimental	Not described Receives: Drug: GSK4532990
GSK4532990 Dose 4	Experimental	Not described Receives: Drug: GSK4532990
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 8 weeks
Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) and up to Week 52

Secondary outcomes (11)

Maximum plasma concentration (Cmax) of GSK4532990
Measured: Up to Day 4
Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990
Measured: Up to Day 4
Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990
Measured: Up to 24 hours
Plasma half-life (t1/2) of GSK4532990
Measured: Up to Day 4
Apparent clearance (CL/F) of GSK4532990
Measured: Up to Day 4
Time to maximum concentration (tmax) of GSK4532990
Measured: Up to Day 4
Apparent terminal phase volume of distribution (Vz/F) of GSK4532990
Measured: Up to Day 4
Change from baseline in serum AST at Week 52
Measured: Baseline (Day 1), and at Week 52
Change from baseline in Enhanced Liver Fibrosis (ELF™) score 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
Measured: Baseline (Day 1), and at Week 52
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990
Measured: Up to Day 3
Maximum observed plasma concentration (Cmax) of GSK4532990
Measured: Up to Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 20247 Mar 2028

First posted26 Sep 2024
Study start27 Sep 2024
Primary completion26 Nov 2027 (estimated)
Study completion7 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Liver Diseases, AlcoholicStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 393 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06613698
Sponsor's protocol ID: 222291
Other IDs: 2024-511596-15
Acronym: STARLIGHT
Status last verified: Jul 2026
First submitted: 23 Sep 2024
Last updated: 3 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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/

Interested in taking part?

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
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NAFLD Clinical Care Pathway
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
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A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
Liver Diseases, Alcoholic

All Liver Diseases, Alcoholic trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT06613698
Acronym / sponsor ID: STARLIGHT / 222291
Conditions: Liver Diseases, Alcoholic
Keywords: GSK4532990, Alcohol-related liver disease, Steatohepatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 393 participants (estimated)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 27 Sep 2024 (actual)
Primary completion: 26 Nov 2027 (estimated)
Study completion: 7 Mar 2028 (estimated)
First posted: 26 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK4532990GSK4532990 will be administered	Drug	GSK4532990 Dose 1, GSK4532990 Dose 2, GSK4532990 Dose 3, GSK4532990 Dose 4
PlaceboPlacebo will be administered	Drug	Placebo

Primary outcome

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

11 secondary outcomes

Maximum plasma concentration (Cmax) of GSK4532990
Time frame: Up to Day 4
Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990
Time frame: 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
Plasma half-life (t1/2) of GSK4532990
Time frame: Up to Day 4
Apparent clearance (CL/F) of GSK4532990
Time frame: Up to Day 4
Time to maximum concentration (tmax) of GSK4532990
Time frame: Up to Day 4
Apparent terminal phase volume of distribution (Vz/F) of GSK4532990
Time frame: Up to Day 4
Change from baseline in serum AST at Week 52
Time frame: 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
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
Maximum observed plasma concentration (Cmax) of GSK4532990
Time frame: Up to Day 3

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
Individual participant dataSharing planned: Yes. 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/

Related trials for Liver Diseases, Alcoholic

Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
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NAFLD Clinical Care Pathway
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RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

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

140 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK4532990 in people with Liver Diseases, Alcoholic, run by GlaxoSmithKline at 140 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Japan, Spain, Argentina, Italy and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06613698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.