Study on the Safety and Effectiveness of GSK4532990 for Adults Aged 18-65 with Alcohol-Related Liver Disease

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What is this study about?

This clinical trial is focused on studying a condition known as alcohol-related liver disease (ALD), which affects the liver due to excessive alcohol consumption. The study will evaluate a new treatment called GSK4532990A, which is a solution for injection developed by GlaxoSmithKline. This treatment is being compared to a placebo to determine its safety and effectiveness in treating ALD.

The purpose of the study is to assess how well GSK4532990A works in reducing liver damage in adults with ALD. Participants will receive a single dose of the treatment through an injection under the skin. The study will monitor participants over a period to observe any changes in their liver condition and to ensure the treatment is safe and well-tolerated.

Throughout the study, participants will undergo various assessments to track their health and the impact of the treatment. These assessments will include regular check-ups and tests to measure liver function and overall health. The study aims to provide valuable information on the potential benefits of GSK4532990A for individuals with alcohol-related liver disease.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide informed consent, which means you agree to participate in the study after understanding all the details and requirements.

You will undergo a series of assessments to confirm your eligibility for the study. These assessments may include medical history review, physical examination, and laboratory tests.

2 safety lead-in phase

In this phase, you will receive a single dose of the study medication, GSK4532990, administered as an injection under the skin (subcutaneous).

The purpose of this phase is to assess the safety and tolerability of the medication. You will be monitored for any side effects or changes in your health.

3 main study period

During the main study period, the effectiveness of GSK4532990 will be evaluated. You will continue to receive the medication as per the study protocol.

Regular follow-up visits will be scheduled to monitor your health and the effects of the medication. These visits may include physical exams, blood tests, and other assessments.

4 end of study

At the end of the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

You will have the opportunity to discuss your experience and any concerns with the study team.

Who Can Join the Study?

Participants must be between 18 and 70 years old at the time of screening. In South Korea, participants must be at least 19 years old.
Participants must have a history of alcohol consumption that is compatible with either Alcoholic Liver Disease (ALD) or Metabolic Alcoholic Liver Disease (MetALD). This means drinking patterns that fit certain criteria, such as consuming a specific number of standard drinks per day or week.
Female participants must not be pregnant or breastfeeding. They must either be women of nonchildbearing potential or use a highly effective contraceptive method with a failure rate of less than 1%. This method should start at least 28 days before the first dose of the study drug and continue during the study and for at least 18 weeks after the last dose. A negative pregnancy test is required within 24 hours before the first dose.
Participants using certain medications can join if their medication dose has been stable for at least 6 months before the study starts and is expected to remain the same during the study. These medications include incretin analogues, PPAR agonists, SGLT2 inhibitors, thyroid hormone receptor beta agonists, FXR agonists, fatty acid synthase inhibitors, FGF21 agonists, or Vitamin E at doses greater than 400 IU per day.
Participants must be able to give signed informed consent before any study-specific procedures. This means they understand and agree to the study’s requirements and restrictions.
Participants must have liver cirrhosis, a condition where the liver is scarred and not functioning properly. This must be confirmed by a previous liver biopsy, medical imaging, or a compatible biochemical profile. The cirrhosis must be classified into one of the following Child-Turcotte-Pugh (CTP) classes: CTP A (Score 5-6), CTP B (Score 7-9), or CTP C (Score greater than 9).
Participants must be willing and able to comply with all study assessments and follow the study schedule of activities.

Who Cannot Join the Study?

Participants with alcoholic liver diseases cannot join the study. This refers to liver problems caused by drinking too much alcohol.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Sydvestjysk Sygehus	Esbjerg	Denmark
Centre Hospitalier Universitaire De Lille	Lille	France
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
Sonomed Sp. z o.o.	Szczecin	Poland
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Eugastro GmbH	Leipzig	Germany
Azienda Ospedaliera di Padova	Padua	Italy
Evangelismos S.A.	Athens	Greece
ID Clinic	Myslowice	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Odense University Hospital	Odense	Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Karolinska University Hospital	Solna	Sweden
Hospital Universitario De Leon	Leon	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hospital General Universitario De Valencia	Valencia	Spain
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH	Berlin	Germany
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Hopital Beaujon	Clichy	France
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie	Homburg	Germany
Urrwsxezluhiqxgmjmamt Kniqujzmbdswtjfyymiidni Bzzgaq Gznp	Bochum	Germany
Hjuievrq Uswjmyxvhabvz Dz Li Pekubjpj	Madrid	Spain
Hnyxxkcs Ukybbbzsxxhtr Mcapoph Dx Vofmhpkqgw	Santander	Spain
Lsbzx Gnpuzxc Hwycztqi On Ahexmm	Athens	Greece
Howsmz Himqqshv	Herlev	Denmark
Uhdkyii Unsvtplyjz Hlpkbrgp	Uppsala	Sweden
Aksswxl Ulgsx Sibwitohm Lxwtyq Db Bvofups	Bologna	Italy
Atmvblb Oecwwjholih Ppbz Gqtsvhkb Xrvqt	Bergamo	Italy
Cusevz Hcfunxbtqth Rospubdv Djueovusttjzfv	Angers	France
Hkydlqby Vjas dxdpseav	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	28.10.2024
France	Recruiting	28.10.2024
Germany	Recruiting	28.10.2024
Greece	Recruiting	28.10.2024
Italy	Recruiting	28.10.2024
Poland	Recruiting	28.10.2024
Spain	Recruiting	28.10.2024
Sweden	Recruiting	28.10.2024

Trial locations

GSK4532990 is a medication being tested to see if it can help people with a liver condition called steatohepatitis, which is related to alcohol use. The study is looking at how safe this medication is and how well it works. It is given as a single injection under the skin. The main goal is to see if it can improve liver health by reducing certain measurements that indicate liver damage. This medication is still being studied, so researchers are trying to find out the best dose and how it affects the liver condition over time.

Investigated diseases:

Alcoholic liver disease

Liver Diseases, Alcoholic – Alcoholic liver diseases are a group of conditions caused by excessive alcohol consumption, leading to liver damage. The progression typically begins with fatty liver, where fat accumulates in liver cells. If alcohol consumption continues, it can lead to alcoholic hepatitis, characterized by inflammation and liver cell damage. Over time, this can progress to fibrosis, where scar tissue forms, and eventually cirrhosis, which is severe scarring that impairs liver function. The liver’s ability to regenerate is compromised, leading to further complications. The progression of these conditions is influenced by the amount and duration of alcohol intake.

Trial ID:

2024-511596-15-00

Protocol code:

222291

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of GSK4532990 for Adults Aged 18-65 with Alcohol-Related Liver Disease

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