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:

• People between 18 and 75 years old.
• People whose cirrhosis was caused by nonalcoholic steatohepatitis (a type of fatty liver disease), alcohol-related liver disease, or chronic viral hepatitis B or C that has been treated.
• People who have a confirmed diagnosis of cirrhosis, shown either by a liver biopsy within the past 5 years showing advanced scarring, or by at least 2 of the following: imaging showing a lumpy liver with an enlarged spleen or a reopened blood vessel; a liver stiffness test result above a certain level; evidence of enlarged veins in the digestive tract; or abnormal blood test results indicating liver damage.
• People whose liver stiffness, measured by a specific type of ultrasound scan, meets certain levels at two separate appointments during the study screening process (confirm with trial site for exact measurement details).
• People whose liver disease is considered "compensated," meaning there is currently no build-up of fluid in the abdomen, no confusion caused by liver failure, and no recent bleeding from enlarged veins — and none of these have occurred in the past 48 weeks.
• People who, if they have had previous liver complications, have not needed treatment for those complications in the past 48 weeks (though blood pressure-lowering beta blocker medication is still allowed).
• People whose liver function score (called Child-Pugh score) is below 8 (confirm with trial site).
• People who are willing and able to provide written consent to participate.

Who may not be able to join:

• People who are currently taking a statin medication, or who have taken one in the past 24 weeks.
• People who have a known medical reason to be on a statin, such as a previous heart attack, stroke, or blood vessel disease; a hereditary cholesterol condition; or a very high LDL cholesterol level.
• People who have had a heart attack, unstable chest pain, a mini-stroke, or a stroke within the past 24 weeks.
• People who score 8 or higher on a standard alcohol use screening questionnaire at the time of screening.
• People who would have difficulty attending the required study visits.
• People who are currently in prison.
• People with a known history of, or current, liver cancer or bile duct cancer.
• People who have previously had certain procedures to redirect blood flow in the liver (such as TIPS, BRTO, or shunt surgery).
• People who have taken certain medications in the past 24 weeks that are known to cause liver scarring or interfere with study results, including amiodarone, methotrexate, or warfarin.
• People who have taken certain medications in the past 24 weeks that may increase the risk of muscle or liver side effects from the study drug — this includes a specific list of medications such as fenofibrate, gemfibrozil, cyclosporin, colchicine, erythromycin, high-dose niacin, certain HIV medications, and a number of other specific drugs (confirm full list with trial site; a short course of 7 days or less may be handled differently).
• People with a blood clot in the veins of the liver or the portal vein.
• People with untreated or unstably treated underactive thyroid (hypothyroidism).
• People receiving nutrition through a tube or directly into a vein (elemental diet or parenteral nutrition).
• People with chronic pancreatitis or a pancreas that does not work properly.
• People whose cirrhosis is caused by something other than fatty liver disease, alcohol, or viral hepatitis — for example, autoimmune liver disease, heart-related liver disease, or certain inherited conditions.
• People with active or unstable inflammatory bowel disease.
• People with an active infection at the time of the trial.
• People who have had any cancer (other than certain minor skin cancers) within the past 3 years.
• People who have previously had an organ transplant or a bone marrow/stem cell transplant.
• People who have had weight-loss (bariatric) surgery in the past 24 weeks, or who have it planned within the next 96 weeks.
• People with serious non-liver organ failure, such as being on kidney dialysis, having advanced heart failure, or needing home oxygen for a lung condition.
• People with a medical or psychiatric condition that, in the treating doctor's opinion, would make participation unsafe or difficult.
• People with certain abnormal blood test results in the past 90 days, including low haemoglobin (anaemia), low albumin (a blood protein), abnormal clotting, high bilirubin levels (unless due to a specific harmless condition), or poorly controlled diabetes.
• People with significant kidney problems, including being on dialysis, having a low kidney function score, or having a large amount of protein in their urine.
• People who have had recent liver complications such as fluid build-up, confusion from liver failure, or bleeding from enlarged veins within the past 48 weeks.
• People with untreated hepatitis B or C — hepatitis C must be cleared from the blood, and hepatitis B must be on treatment with a low virus level.
• People with significantly elevated liver enzyme levels in recent blood tests.
• People with a known history of not tolerating statin medications.
• People with a serious illness that, in the doctor's opinion, means they are unlikely to survive the full study period (approximately 96 weeks).
• People who have used illicit drugs (other than cannabis) — including injected or inhaled drugs — in the 24 weeks before screening.
• People who are pregnant, planning to become pregnant, or breastfeeding.
• People who are currently in, or planning to join, another medication treatment trial at the same time.
• People with significant existing muscle pain or tenderness, or a history of a muscle weakness condition called myasthenia gravis.
• People who are unable or unwilling to provide informed consent.

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