Ongoing Clinical Trials for Metabolic Dysfunction-Associated Liver Disease
This article provides information about 7 ongoing clinical trials investigating treatments for Metabolic Dysfunction-Associated Liver Disease (also known as MASLD, MASH, NAFLD, NASH, Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis). These trials are testing various medications and treatment approaches to reduce liver fat, improve liver inflammation, and prevent progression of liver scarring. Trials are currently being conducted in several European countries and involve both new investigational drugs and existing medications being studied for their effects on liver health.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- Denmark
- France
- Germany
- Greece
- Italy
- Netherlands
- Poland
- Spain
- Study on GSK4532990 for Adults with Nonalcoholic Steatohepatitis (NASH)
- Study of Pioglitazone and Metformin combination treatment for patients with Metabolic Associated Fatty Liver Disease and prediabetes
- Study on the Effectiveness of Rilpivirine-Based Treatment for HIV Patients with Metabolic Liver Disease Using Dolutegravir, Rilpivirine, and Emtricitabine/Tenofovir Combination
- Study on the Effects of Pegozafermin for Patients with Nonalcoholic Steatohepatitis (NASH) and Fibrosis
Study on the Effects of Pegozafermin for Patients with Nonalcoholic Steatohepatitis (NASH) and Fibrosis
This trial evaluates Pegozafermin, a medication administered through injections under the skin, for treating liver inflammation and scarring associated with fatty liver disease. The study runs for up to 36 months, with key assessments at 52 weeks.
Main inclusion criteria: Participants must be between 18 and 75 years old with a body mass index of 25 or higher (23 or higher for Asian participants). They must have a liver biopsy confirming the presence of fatty liver disease with inflammation and fibrosis stage F2 or F3, and a liver damage score of 4 or more showing signs of fat accumulation, cell swelling, and inflammation.
Main exclusion criteria: The trial excludes individuals with severe liver disease, other causes of liver damage, uncontrolled diabetes, serious heart conditions, active cancer, recent major surgery, history of substance abuse within the past 6 months, and pregnant or breastfeeding women.
Treatment focus: The study aims to determine whether Pegozafermin can improve liver tissue health, reduce liver scarring, and decrease the risk of further liver damage. Participants receive either Pegozafermin or placebo injections, and researchers use magnetic resonance imaging to measure changes in liver fat content and other health markers throughout the study period.
Investigational drug: Pegozafermin is being studied for its potential to improve liver health by targeting specific pathways involved in liver metabolism and inflammation, aiming to reduce both liver fat and scarring.
Comparing liquid versus capsule forms of phosphatidylcholine in patients with alcoholic liver disease, chronic hepatitis B, and metabolic liver disease
This study compares two forms of Essentiale medication containing phosphatidylcholine to see if the liquid form works as well as capsules when added to standard treatment. The trial lasts 87 days and includes patients with fatty liver disease, alcoholic liver disease, or chronic hepatitis B.
Main inclusion criteria: Participants must be between 18 and 70 years old, experiencing symptoms such as tiredness, depression, stomach pain, sleep problems, loss of appetite, or nausea with a symptom score of 3 or higher. They must have been diagnosed with metabolic fatty liver disease, alcoholic liver disease, or chronic hepatitis B, and be receiving standard medical care. Women of childbearing potential must use effective birth control, and men with partners who can become pregnant must use condoms.
Main exclusion criteria: The study excludes individuals with severe liver disease, known allergies to study medication components, pregnant or breastfeeding women, those currently in other clinical trials, people with autoimmune diseases, uncontrolled diabetes, serious heart or kidney conditions, recent major surgery, active cancer, and those with recent drug or alcohol abuse.
Treatment focus: The study monitors changes in liver disease symptoms including energy levels, mood, abdominal discomfort, sleep quality, and appetite. Participants receive either liquid Essentiale or capsule form daily while continuing their regular liver disease treatment.
Investigational drug: Essentiale contains essential phospholipids derived from soya beans that help protect and repair liver cells. Both liquid and capsule forms are being compared for effectiveness in supporting liver function and improving symptoms.
Study of Dasatinib and Quercetin combination for treating liver fibrosis in patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
This trial tests a combination of two medications, dasatinib and quercetin, which belong to a class called senolytics that work by removing aging cells contributing to liver damage. The treatment period lasts 21 weeks.
Main inclusion criteria: Participants must be between 18 and 70 years old with fatty liver disease confirmed by non-invasive tests. They must agree to undergo a liver biopsy after treatment and have stable liver function with specific blood test values within acceptable ranges. Weight must be stable with no more than 5% weight loss, and women who can become pregnant must use effective birth control.
Main exclusion criteria: The trial excludes people with other types of liver disease, severe liver damage, pregnancy or breastfeeding, participation in other trials, liver cancer, uncontrolled high blood pressure, severe heart, kidney or lung disease, active infections, excessive alcohol consumption, and inability to undergo liver biopsy.
Treatment focus: The study evaluates whether the combination can improve liver scarring in people with fatty liver disease. Participants take dasatinib up to 180 mg per day and quercetin up to 1000 mg per day in tablet form. Doctors monitor liver condition through blood tests, physical examinations, and non-invasive tests including FibroScan.
Investigational drugs: Dasatinib is a tyrosine kinase inhibitor originally used in cancer treatment, now being studied for its ability to eliminate aging cells. Quercetin is a natural flavonoid with antioxidant properties. Together, they work to remove damaged cells contributing to liver scarring.
Study of Pioglitazone and Metformin combination treatment for patients with Metabolic Associated Fatty Liver Disease and prediabetes
This study investigates how Pioglitazone and Metformin, medications typically used to control blood sugar, affect liver fat in people with prediabetes. The treatment lasts 18 months, and liver fat is measured using magnetic resonance imaging.
Main inclusion criteria: Participants must be between 18 and 75 years old with a body mass index between 25 and 40. They must have fatty liver disease confirmed by MRI showing more than 10% liver fat content and prediabetes indicated by specific blood sugar test results. Both males and post-menopausal females can participate.
Main exclusion criteria: The study excludes people with type 2 diabetes, excessive alcohol consumption, other liver diseases, medications causing fatty liver, pregnancy or plans to become pregnant, active cancer, serious heart conditions, inability to undergo MRI scanning, participation in other trials, severe psychiatric disorders, chronic kidney disease, and body mass index greater than 40.
Treatment focus: The study aims to determine which treatment approach works best in reducing liver fat over 18 months. Researchers examine how the body processes insulin, study gut bacteria, analyze blood substances, and investigate how genetic differences might affect treatment effectiveness.
Investigational drugs: The study involves Pioglitazone (15 mg daily) and Metformin (up to 1000 mg daily), taken as oral tablets to help control blood sugar levels and improve liver function. Different combinations of these medications are tested along with lifestyle recommendations.
Study on GSK4532990 for Adults with Nonalcoholic Steatohepatitis (NASH)
This trial evaluates GSK4532990A, an investigational treatment injected under the skin, for its ability to improve liver health by reducing scarring and resolving inflammation in adults with fatty liver disease. The study lasts 48 weeks.
Main inclusion criteria: Participants must be between 18 and 75 years old with a body mass index of 25 or higher (23 or higher for Asian participants). They must have features of metabolic syndrome with fatty liver disease as the most likely cause, and a liver biopsy showing specific scores for fat buildup, inflammation, and cell damage along with significant scarring. Women of childbearing potential must use highly effective birth control.
Main exclusion criteria: The trial excludes individuals with history of alcohol abuse, other liver diseases such as hepatitis, severe heart problems, uncontrolled diabetes, pregnancy or breastfeeding, recent major surgery, certain liver-affecting medications, cancer history within five years, severe kidney problems, and certain autoimmune diseases.
Treatment focus: The study aims to determine if GSK4532990A can lead to improvement in liver scarring without worsening inflammation, or resolve inflammation without worsening scarring. Participants receive either the investigational treatment or placebo through subcutaneous injection in this double-blind study.
Investigational drug: GSK4532990A works by inhibiting an enzyme called 17 β-Hydroxysteroid Dehydrogenase type 13, which is believed to play a role in the development of liver disease. The medication is currently in Phase 2b clinical trials.
Study on the Effectiveness of Rilpivirine-Based Treatment for HIV Patients with Metabolic Liver Disease Using Dolutegravir, Rilpivirine, and Emtricitabine/Tenofovir Combination
This study focuses on people living with HIV who also have metabolic liver disease. It tests whether a treatment regimen including Rilpivirine, an antiretroviral medication, can help slow down or reduce liver scarring while keeping HIV at very low levels. The study lasts approximately 18 months.
Main inclusion criteria: Participants must be over 18 years old with HIV infection and never previously treated with Rilpivirine. They must have stable antiretroviral therapy for at least 6 months with HIV viral load less than 50 copies/ml. They must have fatty liver disease diagnosed by ultrasound or specific measurements and some degree of liver scarring. Participants must understand the study requirements and agree to long-term commitment.
Main exclusion criteria: The study excludes people without metabolic liver disease and HIV infection, those outside the specified age range, individuals not part of the trial group, and people considered vulnerable populations.
Treatment focus: The study evaluates whether Rilpivirine-based treatment can manage liver health in people with HIV by slowing or reducing liver scarring. Progress is monitored using non-invasive tests throughout the 18-month period. Participants take medication as film-coated tablets daily.
Investigational drug: Rilpivirine is a non-nucleoside reverse transcriptase inhibitor that helps control HIV virus replication. In this trial, it is being studied for its potential benefits in protecting the liver from further damage while maintaining undetectable HIV viral load.
Study on the Effects of Semaglutide on Insulin Resistance and Lipid Metabolism in Women with Obesity and Non-Alcoholic Fatty Liver Disease
This trial studies how weight loss affects the body’s handling of fats and sugars in women with both obesity and fatty liver disease. The treatment is Wegovy, which contains semaglutide, administered as an injection using a pre-filled pen.
Main inclusion criteria: Participants must be women aged 18 or older who understand and speak Danish. They must have a body mass index over 35 with conditions such as joint pain, sleep apnea, or severe high blood pressure, or a body mass index over 50. They must have more than 5% liver fat confirmed by MRI scan or a specific liver fat measurement score.
Main exclusion criteria: The study excludes people not diagnosed with both obesity and fatty liver disease, men, those outside the specific age range, and individuals considered part of vulnerable populations.
Treatment focus: The study explores how significant weight loss affects the body’s processing of blood fats and sugars. Researchers monitor changes over several months, examining insulin resistance, inflammation markers, and liver health indicators. The medication is given as a 2.4 mg subcutaneous injection.
Investigational drug: Wegovy contains semaglutide, which is being studied for its effects on weight loss and its impact on liver health and overall metabolism in women with obesity and fatty liver disease.
Summary
These seven clinical trials represent diverse approaches to treating metabolic dysfunction-associated liver disease and related conditions. The trials are concentrated primarily in Western European countries, with Spain hosting the most trials, followed by multi-country studies across Belgium, France, Germany, Italy, and the Netherlands.
Several trials focus on new investigational drugs specifically developed for liver fibrosis and inflammation, including Pegozafermin and GSK4532990A. Other studies examine existing medications in new applications, such as the senolytic combination of dasatinib and quercetin, and diabetes medications like pioglitazone and metformin for liver health.
The trials vary in duration from 21 weeks to 36 months, with most requiring liver biopsies or advanced imaging to measure treatment effectiveness. Common inclusion criteria across studies include specific body mass index ranges, confirmed liver disease through biopsy or imaging, and stable overall health. Most trials exclude individuals with severe liver damage, other liver diseases, uncontrolled diabetes, serious heart conditions, and pregnant or breastfeeding women.
These studies aim to address the growing need for effective treatments for fatty liver disease, which is closely linked to metabolic conditions such as obesity, diabetes, and insulin resistance. The research may lead to new treatment options for managing this increasingly common condition.
