Ongoing Clinical Trials for Alcoholic Liver Disease
Currently, there are 3 clinical trials investigating new treatments for alcoholic liver disease, taking place across several European countries. These trials are testing different approaches to reduce liver damage and improve liver function in patients affected by excessive alcohol consumption.
Clinical trial locations
- Bulgaria
- Denmark
- France
- Germany
- Italy
- Poland
- Spain
- Sweden
Study on the Safety and Effectiveness of GSK4532990 for Adults Aged 18-65 with Alcohol-Related Liver Disease
This international trial is testing a new medication called GSK4532990, which is given as a single injection under the skin. The study aims to determine whether this treatment can safely reduce liver damage in adults with alcohol-related liver disease.
Who can participate: Adults between 18 and 70 years old with a history of alcohol consumption that has led to liver disease. Female participants must not be pregnant or breastfeeding and must use reliable birth control starting at least 28 days before receiving the study drug and continuing for at least 18 weeks after the last dose. Participants must have liver cirrhosis confirmed by previous liver biopsy, medical imaging, or blood tests. Those taking certain medications for liver conditions can join if their dose has been stable for at least 6 months and will remain unchanged during the study.
Who cannot participate: The trial specifically excludes participants with alcoholic liver diseases, though this appears to be a documentation inconsistency given the trial’s focus.
What the trial involves: Participants will receive a single dose of GSK4532990 through a subcutaneous injection. The study begins with an initial visit where participants provide informed consent and undergo eligibility assessments including medical history review, physical examination, and laboratory tests. During the safety lead-in phase, participants receive the medication and are monitored for side effects. The main study period involves regular follow-up visits to monitor health and assess the medication’s effects through physical exams, blood tests, and other assessments. A final evaluation is conducted at the end of the study.
The medication being tested, GSK4532990, works by targeting specific pathways involved in liver inflammation and damage. Researchers are trying to find out if it can reduce liver stiffness and improve liver function, measured through various indicators of liver health.
Comparing liquid versus capsule forms of phosphatidylcholine in patients with alcoholic liver disease, chronic hepatitis B, and metabolic liver disease
This trial compares two forms of a medication called Essentiale, which contains phosphatidylcholine derived from soya beans. The study is examining whether the liquid form works as well as the capsule form when added to standard treatment for liver conditions.
Who can participate: Adults between 18 and 70 years old who have been diagnosed with fatty liver disease related to metabolic problems, liver disease caused by alcohol, or long-term hepatitis B infection. Participants must have symptoms such as energy loss, feeling depressed, stomach pain, tiredness, trouble sleeping, loss of appetite, or nausea, scoring 3 or higher on an assessment scale. They must be receiving standard medical care for their liver condition and agree to stop drinking alcohol and participate in alcohol treatment if they have a history of alcoholism. Women who can become pregnant must use effective birth control during the study and for 30 days after. Men with partners who can become pregnant must use condoms along with their partner’s contraception.
Who cannot participate: People under 18 or over 65 years old, those with severe liver disease, individuals with known allergies to the study medication, pregnant or breastfeeding women, people participating in other clinical trials, individuals with autoimmune diseases, uncontrolled diabetes, serious heart conditions, severe kidney problems, those who had major surgery within the last 3 months, individuals with active cancer or undergoing cancer treatment, and people with a history of drug or alcohol abuse within the past 6 months.
What the trial involves: Participants will be randomly assigned to receive either Essentiale liquid (1800 mg once daily) with placebo capsules, or Essentiale capsules (300 mg) with placebo liquid. Treatment continues for 87 days while maintaining standard care for liver disease. Regular evaluations assess symptoms using a Global Overall Symptom score, which includes energy loss, depression, abdominal pain, fatigue, sleeping problems, appetite loss, and nausea. Quality of life is also assessed using a specific questionnaire. Safety monitoring occurs throughout the study to record any side effects or new health issues.
The investigational drug, Essentiale, contains essential phospholipids that help protect and repair liver cells. The medication works by incorporating phospholipids into damaged liver cell membranes, helping to restore liver cell function and promote liver regeneration.
Study on Simvastatin for Reducing Liver Fibrosis in Patients with Advanced Alcohol-Related Liver Disease
This Spanish trial is investigating whether simvastatin, a medication commonly used to lower cholesterol, can help reduce liver scarring (fibrosis) in patients with advanced liver damage caused by alcohol.
Who can participate: Adults 18 years or older with chronic liver disease related to alcohol, as defined by international guidelines. Participants must have evidence of significant liver damage from a liver biopsy with a score between 3 and 6 on the Ishak fibrosis scale, which measures the extent of liver scarring. The biopsy must be done at the start of the study or within the last 6 months. Participants should be in the compensated phase of chronic liver disease, meaning the liver is still functioning well without major symptoms. Women who can have children must have a negative pregnancy test and agree to use highly effective birth control methods during the study.
Who cannot participate: Patients with any other serious health conditions that could interfere with the study, those who are pregnant or breastfeeding, patients with recent alcohol or drug abuse, those currently in another clinical trial, patients with known allergies to the study medication, those with severe kidney disease, patients with a history of cancer within the last five years (except certain skin cancers), those with uncontrolled diabetes or high blood pressure, patients who have had a liver transplant, those with HIV or Hepatitis B/C infections, and patients unable to comply with study procedures.
What the trial involves: After initial assessment to confirm eligibility, including a diagnostic liver biopsy if needed, participants are randomly assigned to receive either simvastatin (40 mg tablet daily) or a placebo. This is a double-blind study, meaning neither participants nor researchers know who receives which treatment. The study lasts 24 months with regular follow-up visits at 6, 12, 18, and 24 months. These visits include assessments of liver elasticity using noninvasive methods and blood tests to measure markers related to liver health and inflammation. At the end of 24 months, a final liver biopsy evaluates changes in liver fibrosis.
While simvastatin is usually used to lower cholesterol by inhibiting an enzyme involved in cholesterol production, researchers are exploring whether it can also reduce the severity of liver scarring. The medication’s effects on liver cells may help decrease fibrosis in patients with advanced liver damage due to alcohol consumption.
Summary
Three clinical trials are currently recruiting patients with alcoholic liver disease across Europe. The trials are notably concentrated in Germany and Spain, with Germany hosting two of the three studies. Each trial takes a different therapeutic approach: one tests a novel injectable medication (GSK4532990) targeting liver inflammation pathways, another compares different formulations of a phospholipid-based liver protectant (Essentiale), and the third repurposes a cholesterol-lowering medication (simvastatin) to address liver scarring.
The trials vary significantly in their duration and scope. The GSK4532990 study involves a single injection followed by monitoring, while the Essentiale trial runs for 87 days, and the simvastatin study extends over 24 months. The longest study also requires the most invasive procedures, including liver biopsies at the beginning and end of treatment.
All three trials emphasize the importance of abstinence from alcohol and require participants to engage with alcohol withdrawal programs where applicable. Female participants of childbearing age across all studies must use effective contraception, reflecting the potential risks these medications may pose during pregnancy. The studies collectively represent different stages of liver disease severity, from compensated liver disease to advanced cirrhosis, offering potential treatment options for patients at various points in disease progression.
