Phase 3 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

Written by an AI model from the 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 who are able and willing to read, understand, and sign a written consent form before any study procedures begin
• People aged 18 to 75 years old at the time of enrolment
• People who have, or have had, 2 or more of the 5 features of metabolic syndrome, as defined by the American Heart Association (confirm with trial site for the specific features)
• People who have, or are suspected to have, a liver condition called MASH (a type of liver inflammation linked to fat buildup) along with signs of liver scarring (fibrosis)

Who may not be able to join:

• People whose liver enzyme levels (ALT or AST) are 5 or more times higher than the normal range
• People whose total bilirubin level is 1.3 mg/dL or higher, unless they have a documented condition called Gilbert's syndrome and meet specific additional blood test criteria (confirm with trial site)
• People whose blood albumin level is 3.5 g/dL or lower, indicating possible poor nutrition or liver function
• People with a blood clotting measure (INR) of 1.3 or higher, unless they are on long-term blood thinning medication, in which case the trial doctor may assess eligibility individually
• People whose alkaline phosphatase (a liver-related enzyme) level is 2 or more times higher than the normal range
• People with a platelet count below 140,000 per mm³, though those with counts between 110,000 and 140,000 may be considered after review by the study medical team
• People whose kidney function tests show reduced kidney function, based on specific blood creatinine levels or a calculated kidney function score
• People with elevated levels of a protein called alpha-fetoprotein (20 ng/mL or higher), which can be a marker for certain liver conditions
• People whose HbA1c (a measure of long-term blood sugar levels) is 9.0% or higher, indicating poorly controlled blood sugar
• People with a liver disease severity score (MELD 3.0) of 12 or higher, unless the elevated score is due to a condition unrelated to liver dysfunction such as Gilbert's syndrome
• People whose blood test shows a marker of significant recent alcohol use (PEth at 80 ng/mL or higher) at the screening stage
• People who have a known co-infection with HIV, Hepatitis B, Hepatitis C, Hepatitis D, or Hepatitis E
• People with chronic liver disease from any other cause, including alcoholic liver disease, viral hepatitis, cirrhosis, signs of high blood pressure in the liver's blood vessels, or serious liver complications such as fluid build-up in the abdomen, bleeding in the digestive tract, kidney problems linked to liver disease, or confusion caused by liver disease
• People who have had a pattern of excessive alcohol consumption lasting 3 months or more at any point in the 12 months before screening

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