Phase 3 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 able to understand and willing to sign a consent form before any study activities begin
• You are between 18 and 75 years old at the time of joining
• You have been diagnosed with 2 or more features of metabolic syndrome (such as high blood pressure, high blood sugar, excess belly fat, high triglycerides, or low "good" cholesterol), as defined by the American Heart Association
• A liver biopsy has confirmed you have a specific liver condition called MASH (a form of fatty liver disease with inflammation) with moderate-to-significant scarring (stage F2 or F3) and a disease activity score of 4 or higher, confirmed by a specialist

Who may not be able to join:

• You are unable to safely have a needle biopsy of the liver for any reason
• Your liver enzyme levels (ALT or AST) are 5 times or more above the normal range
• Your bilirubin (a substance made by the liver) level is too high, unless you have a specific harmless condition called Gilbert's syndrome and meet certain additional blood test requirements (confirm with trial site)
• Your blood albumin (a protein made by the liver) level is too low
• Your blood clotting score (INR) is too high, unless it is because you are already taking blood thinners — in some cases this may still be allowed after review (confirm with trial site)
• A liver enzyme called alkaline phosphatase is more than twice the normal upper limit
• Your platelet count (cells that help blood clot) is below a certain level, though people with counts in a borderline range may be considered after discussion with the study team (confirm with trial site)
• Your kidney function is below a certain level, based on a creatinine blood test or kidney function calculation
• A protein called alpha-fetoprotein, which can be a sign of liver problems, is above a certain level in your blood
• Your HbA1c (a measure of blood sugar control over time) is 9.0% or higher
• Your liver disease severity score (called MELD) is 12 or above, unless the score is elevated for a non-liver-damage reason such as Gilbert's syndrome
• A blood marker that can indicate heavy alcohol use (called PEth) is above a certain level at your screening visit
• You are currently infected with HIV, Hepatitis B, or Hepatitis C
• You have another type of chronic liver disease, signs of advanced liver complications (such as fluid build-up in the abdomen, internal bleeding from the digestive tract, or mental confusion caused by liver problems), or your biopsy shows cirrhosis (severe liver scarring)
• You have had a history of drinking too much alcohol for 3 or more months during the year before your screening visit

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