Phase 2 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:

• You are between 9 and 22 years old and have been diagnosed with non-alcoholic fatty liver disease (NAFLD).
• Your liver enzyme levels (called ALT) are higher than normal — specifically above 50 U/L for boys or above 44 U/L for girls.
• You are either overweight or obese based on your age-appropriate BMI range (for those 18 and older, overweight means a BMI of 25 or more; obese means a BMI of 30 or more).
• If you are overweight but not obese, you also have at least one related health concern such as belly fat, a family history of fatty liver disease, pre-diabetes or diabetes, abnormal cholesterol levels, or sleep apnea.
• An ultrasound or FibroScan scan has shown that more than 5% of your liver contains fat, OR a previous liver biopsy showed findings consistent with NAFLD.
• Adult female participants who could become pregnant must not be pregnant, must not be breastfeeding, must not plan to become pregnant during the study, and must agree to use two highly effective forms of birth control throughout the study and for at least 30 days after the last dose (confirm with trial site for full details).
• Adult male participants who are sexually active with a partner who could become pregnant must agree to use appropriate birth control from the start of the study until 30 days after the last dose, and must not donate sperm during that time (confirm with trial site for full details).

Who may not be able to join:

• People who have had a heart attack, stroke, or blood clots (deep vein thrombosis).
• People with a history of cancer, organ transplant, or certain immune system conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease, or severe psoriasis.
• People with poorly controlled thyroid disease or uncontrolled high blood pressure.
• People who have advanced liver disease (cirrhosis) or signs that the liver is no longer working properly.
• People whose liver blood test results are very high — such as ALT or AST above 200, bilirubin above 2.0, ALP above 500, GGT above 200, or INR above 1.4.
• People with any severe illness or poorly controlled mental health condition that the trial doctor feels would make participation unsafe.
• People with poorly controlled diabetes or a blood sugar control measure (HbA1c) above 9%.
• People who report binge drinking alcohol.
• People who use tobacco, vape, use marijuana, or use illegal drugs.
• People with signs of serious liver function problems, including low albumin levels, a low platelet count, or blood clotting problems.
• People with abnormal kidney function based on age- and sex-specific normal ranges (confirm with trial site for the specific numbers that apply to your age).
• Women who are currently breastfeeding.
• People who are already participating in another drug trial.
• People with a known allergy or severe allergic reaction to ragweed.

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