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 have signed and dated a consent form agreeing to take part in the study
• People who are willing to follow all study procedures and are available for the full length of the study
• People aged between 18 and 75 years (male or female)
• People who show signs of metabolic dysregulation — either diagnosed with Type 2 diabetes for at least 90 days with a blood sugar marker (HbA1c) above 6.5, and on stable diabetes medication (if any) for at least 90 days before screening; OR people who meet at least one of the following six metabolic health markers: a BMI over 25; a waist measurement over 102 cm for men or over 88.9 cm for women; fasting triglycerides (blood fats) above 150 mg/dL or currently on triglyceride-lowering medication; HDL ("good") cholesterol below 40 mg/dL for men or below 50 mg/dL for women, or currently on cholesterol-lowering medication; fasting blood sugar above 100 mg/dL; or blood pressure reading with the top number above 130 mmHg and/or bottom number above 85 mmHg, or currently on blood pressure medication
• People with a liver scarring score called FIB-4 above 1.3 (for those under 65) or above 2.0 (for those over 65)
• People who agree to follow lifestyle recommendations outlined by the study team for the full duration of the trial

Who may not be able to join:

• People with a known history of chronic liver disease other than MASLD/MASH (a specific type of liver condition), such as hepatitis B or C, autoimmune liver disease, certain bile duct conditions, liver cancer, a history of liver transplantation, prior liver surgery, or other listed liver conditions
• People who have or have had signs of severe liver failure, such as visible fluid build-up in the abdomen needing water tablets, confusion caused by liver disease needing treatment, or bleeding from swollen veins in the digestive system
• People with a specific liver enzyme (ALT) level more than five times the upper limit of normal in blood tests
• People who currently drink, or in the last two years have drunk, more than moderate amounts of alcohol — defined as on average more than 1 standard drink per day or 14 per week for women, and more than 2 standard drinks per day or 21 per week for men; or people with an alcohol use questionnaire (AUDIT) score of 7 or higher, or a blood alcohol marker (PEth) of 20 ng/mL or above
• People for whom a liver biopsy (a small tissue sample from the liver) is not safe, for example due to blood clotting problems, low platelet counts, or being on certain blood-thinning medications — as determined by the study doctor
• People with very high uncontrolled blood pressure (top number above 180 mmHg and bottom number above 120 mmHg) at the screening visit
• People with any other serious systemic illness that the study doctor considers would make participation unsafe
• People who are unable or unwilling to give informed consent
• People who are not willing to have a liver biopsy
• People who are unable or unwilling to follow study requirements, such as fasting before certain tests
• People who the study doctor considers unable to complete study procedures
• People who are unable or unwilling to have an MRI scan — for example, due to certain implanted medical devices such as a pacemaker, or a body size that would not fit the MRI scanner (unless a wider machine is available) (confirm with trial site)
• People who are pregnant or planning to become pregnant within 4 months of the screening visit
• People who have taken part in another clinical trial within the last 30 days, or who have received an experimental treatment within the last 90 days before signing the consent form for this study

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