Study on GSK4532990 for Adults with Nonalcoholic Steatohepatitis (NASH)

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What is this study about?

This clinical trial is focused on studying a liver condition known as Nonalcoholic Steatohepatitis (NASH), which is a more severe form of Non-alcoholic Fatty Liver Disease (NAFLD). NASH involves liver inflammation and damage caused by a buildup of fat in the liver. The study is testing a new treatment called GSK4532990A, which is a solution for injection developed by GlaxoSmithKline. The purpose of the study is to evaluate whether this treatment can help improve liver health by reducing liver fibrosis (scarring) and resolving NASH in adults who have this condition.

Participants in the study will receive either the new treatment, GSK4532990A, or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The treatment will be administered through subcutaneous injection, which means it is injected under the skin. The study will last for a period of 48 weeks, during which participants will be monitored for any changes in their liver condition.

The main goal of the study is to see if GSK4532990A can lead to an improvement in liver fibrosis without worsening NASH, or if it can resolve NASH without worsening fibrosis. Participants will undergo various assessments to track their liver health throughout the study. This research aims to provide valuable insights into the potential benefits of GSK4532990A for individuals with NASH, potentially leading to new treatment options for this liver disease.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A liver biopsy is performed to assess the condition of the liver using the NASH CRN Scoring System. This helps determine the presence of Nonalcoholic Steatohepatitis (NASH) and the level of fibrosis.

2 medication administration

Participants receive the study medication, GSK4532990, administered via subcutaneous injection. The exact dosage and frequency are determined by the study protocol.

In addition to the study medication, participants may receive a 0.9% Sodium Chloride Injection as a placebo or control.

3 ongoing monitoring

Regular follow-up visits are scheduled to monitor the participant’s health and response to the medication. These visits include physical examinations and laboratory tests.

Participants are required to report any side effects or changes in their health status during these visits.

4 final assessment

After 52 weeks, a final assessment is conducted to evaluate the effectiveness of the treatment. This includes another liver biopsy to measure any changes in fibrosis and NASH resolution.

The primary goal is to achieve improvement in liver fibrosis without worsening NASH, or to resolve NASH without worsening fibrosis.

Who Can Join the Study?

Participant must be between 18 and 75 years old at the time of screening.
Must have a Body Mass Index (BMI) of 25 or higher. BMI is a measure of body fat based on height and weight. For Asian participants, a BMI of 23 or higher is required.
The investigator believes that the participant has features of metabolic syndrome, and the most likely cause of liver disease is Non-alcoholic Fatty Liver Disease (NAFLD). Metabolic syndrome can include conditions like type 2 diabetes, obesity, abnormal cholesterol levels, and high blood pressure.
A liver biopsy must show a NAS score of 4 or more, with at least 1 point each in fat buildup, inflammation, and cell damage, and a Fibrosis score of 3. This is confirmed by a central scoring system.
Must be able to give signed informed consent before any study-specific procedures are done.
Must be able and willing to follow all study assessments.
If female, must not be pregnant or breastfeeding. If of childbearing potential, must use a highly effective birth control method with a failure rate of less than 1%. This should start from the time of a negative pregnancy test at screening and at least 28 days before the first study intervention, continuing during the study and for at least 18 weeks after the last intervention. A negative pregnancy test is required within 24 hours before the first dose of the study intervention.

Who Cannot Join the Study?

Individuals with a history of alcohol abuse or dependence cannot participate.
Participants with other liver diseases, such as hepatitis, are excluded.
People with severe heart problems are not eligible.
Individuals with uncontrolled diabetes cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Participants who have had recent major surgery are excluded.
People taking certain medications that affect the liver cannot participate.
Individuals with a history of cancer within the last five years are not eligible.
Participants with severe kidney problems are excluded.
People with certain autoimmune diseases cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Azienda Ospedaliera di Padova	Padua	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Hopital Beaujon	Clichy	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Cntrwnxef Unpjuvuvdqqapt Sawgnjevt	Woluwe-Saint-Lambert	Belgium
Hazbargv Urvssamdrrqnc Mkolzjd Dx Vvmvkkfkvf	Santander	Spain
Pgen Tszjd Hldppugq Uyzumbhoofax	Sabadell	Spain
Caabqo Hbaajmvnbca Ei Unsmamsnmzzho Dj Lxcberl	Limoges	France
Uguawemfgy Og Apihrxu	Edegem	Belgium
Cphczo Hgnplnhqivj Rwuonvgy Dpdxnipqztkbrs	Angers	France
Hzkrihco Vvwh dtfbelec	Barcelona	Spain
Hanilegf Uctkdpojsaaltl Shokwmbzmx &lcoxtc Hzcmrdk dr Huxomnddeno	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	21.04.2023
France	Not recruiting	21.04.2023
Greece	Not recruiting	21.04.2023
Italy	Not recruiting	21.04.2023
Spain	Not recruiting	21.04.2023

Trial locations

Investigated drugs:

Gsk4532990A

GSK4532990 is a medication being studied for its potential to treat nonalcoholic steatohepatitis (NASH), a liver condition. The trial aims to see if this medication can help reduce liver fibrosis (scarring) or resolve NASH in patients.

Investigated diseases:

Metabolic dysfunction-associated liver disease

Non-alcoholic Fatty Liver Disease – This condition occurs when fat builds up in the liver of people who drink little or no alcohol. It is often associated with obesity, insulin resistance, and metabolic syndrome. The disease can progress from simple fatty liver (steatosis) to non-alcoholic steatohepatitis (NASH), which involves liver inflammation and damage. Over time, NASH can lead to fibrosis, where scar tissue forms in the liver, and potentially progress to cirrhosis, a severe scarring that affects liver function. The progression of the disease is often slow and may not cause noticeable symptoms in the early stages. As the disease advances, individuals may experience fatigue, discomfort in the upper right abdomen, and other symptoms related to liver dysfunction.

Trial ID:

2023-507503-62-00

Protocol code:

218672

NCT ID:

NCT05583344

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on GSK4532990 for Adults with Nonalcoholic Steatohepatitis (NASH)

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