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:

• You are a man or woman (before or after menopause)
• You are overweight or obese, with a BMI of 25.9 or higher
• You drink less than 20 grams of alcohol per day (roughly 1.5 standard drinks)
• You have type 2 diabetes and have been on a stable diabetes medication dose for at least 3 months before joining
• If you take vitamin E or pioglitazone, you have been on a stable dose for at least 6 months before joining
• You have 3 or more features of metabolic syndrome, such as a large waistline, high blood pressure, low "good" cholesterol, high triglycerides (fats in the blood), or high fasting blood sugar
• You are already scheduled to have a liver biopsy for medical reasons
• If you are a woman who could become pregnant, you must have a negative pregnancy test, not be breastfeeding, not plan to become pregnant during the study, and agree to use two reliable forms of birth control throughout the study and for at least 30 days after the last dose (confirm with trial site for accepted methods)
• If you are a woman who cannot become pregnant due to surgery (such as removal of ovaries, hysterectomy, or tubal ligation) or naturally (no period for more than 12 months in a row), you are also eligible
• If you take the heart medications digitalis or amiodarone, you may still be eligible but must continue taking them throughout the treatment and have your heart doctor monitor you closely

Who may not be able to join:

• You have another known cause of liver disease, such as hepatitis B or C, autoimmune hepatitis, iron overload (hemochromatosis), celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, or liver damage caused by a medication
• You drink 20 grams or more of alcohol per day (roughly 1.5 or more standard drinks)
• You have advanced liver scarring (cirrhosis), or certain abnormal liver test results showing poor liver function
• You have signs of high blood pressure in the liver's blood vessels (portal hypertension)
• You are pregnant
• You have a history of severely dangerous high blood pressure (malignant hypertension)
• Your blood pressure is not well controlled, with a top number above 160 or a bottom number above 100 at your screening visit
• You have serious heart failure (confirmed with trial site) or your heart's pumping strength is very low (below 30%)
• You have an uncontrolled irregular heartbeat, or certain abnormal heart rhythm readings on an ECG test
• You have had a heart attack, unstable chest pain, heart surgery, or a stroke within the 3 months before joining the study
• You have a specific type of serious heart conduction problem (a high-degree AV block) and do not have a pacemaker
• You have an adrenal gland problem that has not been treated or corrected
• You are taking certain antidepressants (tricyclic or tetracyclic) or the anesthetic ketamine and are not able or willing to stop them for a required period before joining
• You are currently taking the medications teduglutide or midodrine

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