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 between 30 and 70 years old.
• You have been diagnosed with a liver condition called NASH (a type of fatty liver disease) with results above a certain severity level, AND/OR you have Type 2 diabetes or prediabetes with a recent blood sugar test (HbA1c) below 9%, AND/OR your Body Mass Index (BMI) is between 35 and 60.
• You are willing to be randomly assigned to either treatment group in the study.
• You have health insurance that covers obesity-related treatments and any complications from obesity surgery.
• A scan shows that fat is present in your liver at the start of the study.
• You are able to safely have a liver biopsy (a small sample taken from the liver).
• You are willing and able to follow the study schedule, including completing an initial preparatory period before the study begins.
• You are able to speak and understand English.
• You are willing to sign a consent form agreeing to take part.

Who may not be able to join:

• You have had a heart attack, stroke, chest pain episode, or heart-related procedure in the past 6 months.
• You currently have heart failure, ongoing chest pain (angina), or significant problems with blood flow in your legs.
• You have had a blood clot in the lungs or veins in the past 6 months.
• You have or have had cancer of any kind (except certain minor skin cancers) unless you have been confirmed cancer-free for at least 5 years.
• You have significant anemia (low red blood cell levels) or a history of problems with blood clotting.
• Your blood test shows your kidneys are not working well enough (creatinine above 1.8 mg/dL).
• Your blood tests show certain liver markers are significantly above the normal range, or your blood clotting time is abnormal (confirm with trial site).
• You drink more than one alcoholic drink per day (or more than 20 grams of alcohol per day).
• You have previously had surgery on your stomach, bile duct, pancreas, spleen, or colon.
• You have had a stomach or small intestine ulcer in the past 6 months.
• You have had a serious internal abdominal infection in the past (with some exceptions for appendix or bowel issues more than 6 months ago).
• You have previously had an organ transplant.
• You have HIV, active tuberculosis, active malaria, chronic hepatitis B or C, liver cirrhosis, or inflammatory bowel disease.
• You are currently pregnant, breastfeeding, or planning to become pregnant within the next 2 years.
• You have had a dependency on alcohol, drugs, or opioids (not including nicotine) in the past 5 years.
• You have an active mental health or psychological condition that might make it hard to follow the study plan.
• You score 17 or higher on a specific depression questionnaire (called the CES-D) based on a typical week for you.
• You have any long-term or serious illness that would make it difficult to follow the study requirements.
• A blood test shows your c-peptide level (a marker related to insulin production) is below 1.0 ng/ml after eating.
• You have a history of an endoscopy showing inflammation or cell changes in your esophagus (the tube connecting your mouth to your stomach).
• You have any history of difficulty swallowing.
• Your liver scarring (fibrosis) score is higher than 3 (confirm with trial site).
• You are currently taking a medication called Rezdiffra (resmetirom).
• The study doctors or eligibility committee may also exclude someone based on their individual judgment.

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