Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are a man or a non-breastfeeding woman between 18 and 80 years old with a liver biopsy confirming NASH (a type of fatty liver disease) at a scarring level of F1 to F4 (with F4 being early-stage cirrhosis that is still compensated, meaning the liver is still functioning)
• You are willing to use appropriate birth control throughout the study and for 90 days after it ends
• Your body mass index (BMI) is greater than 23 (a measure of body weight relative to height)
• A special liver scan (MRI-PDFF) shows that at least 5% of your liver is made up of fat
• Your liver biopsy (taken either during screening or within the last 6 months) confirms NASH with a disease activity score of 4 or higher, showing damage in three specific areas: fat buildup, cell swelling, and inflammation
• Your liver enzyme levels (ALT and AST) have not gotten significantly worse (risen by more than 50%) in the 2 months before your screening visit
• Your blood test results at screening fall within acceptable ranges for kidney function, blood sugar, blood cell counts, liver function, and other markers (confirm with trial site for specific values)
• A liver stiffness scan (FibroScan®) gives a reading between 7.0 and 20.0 kPa
• If you take medication for diabetes (non-insulin), weight loss, or cholesterol, you have been on a stable dose for at least 3 months before your liver biopsy and up to the point of joining the study
• If you take vitamin E or pioglitazone, your dose has been stable before your liver biopsy and must stay stable throughout the study

Who may not be able to join:

• Your weight has changed by more than 5% in the 3 months before joining, or more than 10% in the 6 months before screening
• You have Type 1 diabetes or Type 2 diabetes that requires insulin
• Your blood pressure is poorly controlled (above 160/100 mmHg)
• You have had serious liver complications in the past, such as fluid buildup in the abdomen, confusion caused by liver failure, or bleeding from swollen veins in the food pipe or stomach
• You have a chronic hepatitis B infection
• You have a chronic hepatitis C infection, or were cured of hepatitis C less than 1 year before screening
• You have had weight-loss (bariatric) surgery in the past, or are planning to have it during the study (surgery done more than 2 years ago may still be eligible — confirm with trial site)
• Your liver disease is caused by something other than NASH, such as alcohol, autoimmune conditions, certain medications, or inherited liver conditions
• You have previously had a liver transplant
• You have an active primary cancer (certain exceptions may apply — confirm with trial site)
• You drink more than 2 alcoholic drinks per day on average (if you are a woman) or more than 3 per day (if you are a man)
• You have an HIV infection
• You have had an unstable heart or cardiovascular condition in the 6 months before screening
• Your life expectancy is less than 2 years
• You have taken part in another clinical trial or used an experimental medication within the past 30 days (or longer, depending on the medication)
• You have used or currently use certain prescription drugs known to cause fat buildup in the liver (such as methotrexate, amiodarone, tamoxifen, or steroids) within the past 12 months (confirm with trial site for the full list)
• You cannot have an MRI scan — for example, because you have a pacemaker, a defibrillator, metal in your eye, or certain other medical devices in your body
• Your liver disease severity score (called MELD score) is above 12 (confirm with trial site)
• You have swollen veins in your food pipe or stomach that have bled within the past year

Important: Always verify eligibility with the trial site directly before applying.