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 have a BMI over 30, or your BMI is above the 95th percentile for your age group
• You weigh between 75 kg and 150 kg (approximately 165 to 330 pounds)
• You are between 16 and 20 years old at the start of the study
• You have either an elevated liver enzyme level (ALT) detected in a blood test in the past 3 months, OR you have been diagnosed with fatty liver disease through an ultrasound, MRI, or liver biopsy within the past 12 months
• You have previously tried lifestyle changes (such as diet or exercise) to treat obesity or fatty liver disease
• You are at a certain stage of physical development (puberty stage 2 or above — confirm with trial site)
• Your fasting blood sugar level is in the normal range (below 100 mg/dL)
• You are willing to follow lifestyle guidelines throughout the study
• An MRI scan confirms that fat in your liver is at or above a certain level (5.5% or more), if this method is being used to confirm your eligibility

Who may not be able to join:

• Your liver enzyme (ALT) level is very high (above 250 U/L) at the screening visit
• You have a history of significant alcohol use, or you currently drink alcohol
• Your fasting blood sugar is above 100 mg/dL
• You have been diagnosed with type 1 or type 2 diabetes
• You have used weight loss medications in the past 6 months
• You currently take Vitamin E supplements or metformin (a 30-day stop period may allow re-screening — confirm with trial site)
• You have previously had weight loss (bariatric) surgery
• You have previously taken the medication empagliflozin
• You have had an infection or open sore on your lower leg or foot in the past 3 months
• You have metal implants, devices, or objects in or on your body that are not safe for MRI scans
• You have certain structural or functional problems with your urinary or genital system that make infections more likely (confirm with trial site)
• You recently started blood pressure or cholesterol medications within the past 3 months
• You have a major psychiatric (mental health) disorder
• You have a known problem with your hypothalamus or pituitary gland (parts of the brain that control hormones)
• You are currently pregnant or planning to become pregnant
• You are female and unwilling to take a pregnancy test
• You are female, sexually active, and not using an effective form of birth control (a 30-day re-screening period may apply after starting birth control — confirm with trial site)
• You use tobacco products
• You have significantly poor liver function, shown by very high levels of certain liver-related markers in blood tests (confirm specific values with trial site)
• Your platelet count (a measure of blood clotting cells) is too low
• Certain other blood test results related to liver function fall outside acceptable ranges (confirm with trial site)
• You have been diagnosed with Gilbert's Syndrome (a genetic liver condition)
• You have any known liver disease other than fatty liver disease (NAFLD or NASH)
• You have significantly reduced kidney function
• You have been diagnosed with a genetic form of obesity
• You have a history of cancer
• You have an untreated thyroid condition
• You have had serious complications related to liver disease, such as fluid build-up in the abdomen, bleeding from swollen veins, confusion caused by liver failure, or liver cancer
• You are currently using, or have used in the past 6 months, medications known to cause weight gain (such as certain antipsychotic medications)

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