Ongoing Clinical Trials for Liver Disorder
Four clinical trials are currently investigating different treatment approaches for liver disorder, including conditions such as compensated advanced chronic liver disease, non-alcoholic fatty liver disease, and alcohol-related liver disease. These trials are being conducted across Austria, Spain, and Sweden, testing medications like Telmisartan, Zinc Acexamate, Simvastatin, and Orlistat.
Clinical trial locations
- Austria
- Spain
- Sweden
Study on Telmisartan for Reducing Portal Hypertension in Patients with Advanced Chronic Liver Disease
This trial is testing Telmisartan, a medication commonly used for high blood pressure, to see if it can reduce pressure in the liver veins in patients with compensated advanced chronic liver disease and portal hypertension.
Main inclusion criteria: Patients aged 18 to 79 years with compensated advanced chronic liver disease and clinically significant portal hypertension, measured as a hepatic venous pressure gradient of 10 mmHg or more. Participants must have a Child-Pugh stage A or B and a model for end-stage liver disease score of 15 or less.
Main exclusion criteria: Patients with uncontrolled high blood pressure, severe heart problems, unstable kidney problems, previous liver transplant, active infections requiring treatment, pregnancy or breastfeeding, current participation in another clinical trial, recent history of alcohol or drug abuse, mental health conditions that may affect study compliance, or allergies to the study medication.
Focus and goal: The main goal is to evaluate whether Telmisartan can lower the hepatic venous pressure gradient after 12 weeks of daily treatment. The study will also measure changes in liver and spleen stiffness throughout the treatment period.
Investigational drug: Telmisartan works by blocking the action of angiotensin II, a substance that causes blood vessels to tighten, thereby helping to relax and widen blood vessels. It is an angiotensin II receptor blocker being studied for its potential to reduce portal hypertension.
Study on Zinc Acexamate for Patients with Advanced Chronic Liver Disease
This trial is investigating Zinc Acexamate in patients with advanced stages of chronic liver disease to determine if it can improve health outcomes and reduce the risk of serious liver-related events.
Main inclusion criteria: Patients aged 18 to 80 years with chronic liver disease diagnosed by hepatic stiffness measurement showing a result greater than 15 kPa. Participants must have no previous or current decompensation. Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study.
Main exclusion criteria: Patients with chronic liver disease are mentioned in the exclusion criteria, which appears to be an inconsistency in the source data, as this contradicts the inclusion criteria.
Focus and goal: The study aims to determine if Zinc Acexamate can reduce clinical events and improve the prognosis of patients with advanced chronic liver disease. The trial will run until January 2028, monitoring participants regularly throughout this period.
Investigational drug: Zinc Acexamate provides elemental zinc and is thought to support liver function by reducing inflammation and oxidative stress, potentially protecting liver cells from damage. Participants take 600 mg daily, providing 100 mg of elemental zinc.
Study on Simvastatin for Reducing Liver Fibrosis in Patients with Advanced Alcohol-Related Liver Disease
This trial is studying whether Simvastatin, a medication commonly used to lower cholesterol, can help reduce liver scarring in patients with advanced alcohol-related liver disease.
Main inclusion criteria: Patients must be 18 years or older with chronic liver disease related to alcohol, as defined by international guidelines. Evidence of significant liver fibrosis from a liver biopsy with a score between 3 and 6 on the Ishak fibrosis scale is required. Participants must be in the compensated phase of chronic liver disease. Women of childbearing potential must have a negative pregnancy test and agree to use highly effective birth control methods.
Main exclusion criteria: Other serious health conditions that could interfere with the study, pregnancy or breastfeeding, recent history of alcohol or drug abuse, current participation in another clinical trial, known allergies to the study medication, severe kidney disease, history of cancer within the last five years (except certain skin cancers), uncontrolled diabetes or high blood pressure, previous liver transplant, HIV or Hepatitis B/C infections, and inability to comply with study procedures.
Focus and goal: The primary goal is to determine if Simvastatin can significantly reduce liver fibrosis over 24 months. The study will assess liver health through liver biopsies, liver stiffness measurements, blood markers, changes in gut microbiome, and inflammation markers.
Investigational drug: Simvastatin is a statin that works by inhibiting an enzyme involved in cholesterol production, which may also have effects on liver cells and reduce fibrosis. Participants take one 40 mg tablet orally each day for the duration of the study.
Study on Orlistat’s Effect on Liver Fat in Obese Patients with Non-Alcoholic Fatty Liver Disease and High Proneurotensin Levels
This trial is examining whether Orlistat can reduce liver fat content in obese patients with non-alcoholic fatty liver disease who have high levels of proneurotensin in their blood.
Main inclusion criteria: Patients aged 20 to 65 years with a body mass index of 30 kg/m² or higher, plasma concentration of pro-NTS greater than 150 pmol/L, and liver fat content greater than 5.6% without other causes of liver fat accumulation. Women of childbearing potential require a negative pregnancy test and written informed consent is required from all participants.
Main exclusion criteria: Having a medical condition other than non-alcoholic fatty liver disease, not having a BMI of 30 or higher, not having high levels of pro-NTS in the blood, and being part of a vulnerable population requiring special protection or care.
Focus and goal: The primary goal is to determine if taking Orlistat for 24 weeks can significantly reduce liver fat content compared to placebo. The study will also monitor changes in body weight, insulin sensitivity, fasting plasma glucose, blood sugar levels after glucose intake, plasma triglycerides, cholesterol levels, and blood pressure.
Investigational drug: Orlistat is a lipase inhibitor that works by blocking the absorption of dietary fats in the digestive system. Participants take 120 mg capsules orally three times a day with each main meal containing fat for 24 weeks.
Summary
These four clinical trials represent diverse approaches to treating different types of liver conditions across Europe. Two trials are being conducted in Spain, focusing on zinc supplementation and statin therapy for advanced chronic liver disease and alcohol-related liver disease, respectively. Austria is hosting research on portal hypertension management, while Sweden is investigating fat reduction in non-alcoholic fatty liver disease.
The trials test a range of therapeutic strategies: repurposing blood pressure medication for portal hypertension, using mineral supplementation for liver health support, exploring cholesterol-lowering drugs for fibrosis reduction, and applying weight-loss medication for fatty liver management. Most studies require participants to be in relatively early stages of liver disease without severe complications, emphasizing the focus on preventing disease progression rather than treating advanced complications.
The duration of these trials varies considerably, from 12 weeks to 24 months, reflecting the different mechanisms of action and expected timelines for therapeutic effects. All studies employ double-blind, placebo-controlled designs to ensure reliable results.