Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Completed

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:

• Adults aged 18 or older.
• People who have been diagnosed with a specific liver condition called NASH (non-alcoholic steatohepatitis), confirmed by a liver biopsy taken within 6 months before the screening visit or during screening, showing a certain level of liver fat, inflammation, and cell damage — but not the most severe stage of scarring (confirm with trial site for exact scoring details).
• People willing to have another liver biopsy after 24 weeks of treatment.
• People whose liver disease is stable and not causing serious complications (known as "compensated" liver disease).
• People whose liver condition is not caused by other liver diseases such as autoimmune conditions, hepatitis B or C, or certain inherited disorders.
• People with type 2 diabetes (if applicable) whose condition has been stable — meaning blood sugar levels have been within a certain range, no changes in diabetes medication in the past 6 months, and no new serious diabetes symptoms in the past 3 months.
• People whose weight has been stable since their liver biopsy, with no more than a 5% loss of body weight.
• Women who are not pregnant and have had a negative pregnancy test, or who are post-menopausal; women who could become pregnant must be using a highly effective form of contraception and continue it for at least one menstrual cycle after the study ends.
• People who have read and signed a written consent form agreeing to take part.

Who may not be able to join:

• People who have another form of liver disease.
• People with a history of regularly drinking large amounts of alcohol — more than 3 standard drinks per day for men, or more than 2 standard drinks per day for women.
• People with an unstable metabolic condition, such as weight change of more than 5 kg in the past three months, poorly controlled diabetes, or who have recently started a diabetes or weight-loss medication, or had weight-loss surgery in the past 6 months.
• People who have had certain types of weight-loss (bariatric) surgery within the last 5 years, or who have taken certain medications known to cause liver fat build-up (such as steroids, high-dose estrogens, methotrexate, tetracycline, or amiodarone) in the past 6 months.
• People with serious other health conditions such as severe heart failure, unstable heart disease, stroke-related conditions, serious lung disease, kidney failure, a history of organ transplant, serious psychiatric illness, or active cancer — where the trial doctor believes these would interfere with safe participation.
• People who currently have active hepatitis B, hepatitis C (unless their hepatitis C has been undetectable for more than 3 years), or HIV infection.
• Women who are pregnant or breastfeeding, or who are unable to use adequate contraception.
• People with an active cancer (except a specific type of non-serious skin cancer called cutaneous basal cell carcinoma).
• People with any other condition that the trial doctor believes would prevent them from safely completing the study.
• People with a body mass index (BMI) above 45.
• People with type 1 diabetes, or people with type 2 diabetes who are on insulin.
• People who have a condition called diabetic ketoacidosis.
• People with very high levels of fats called triglycerides in their blood (above a certain threshold — confirm with trial site).
• People with blood clotting disorders or who are currently taking blood-thinning medications.
• People for whom a liver biopsy would not be medically safe.
• People with a history of, or current, heart rhythm problems or a history of a cardiovascular event such as a heart attack — except those with only well-controlled high blood pressure. People with a significant abnormality found on a heart tracing (ECG) are also excluded.
• People who have taken part in another clinical trial within the past 3 months.
• People who have a known allergy or sensitivity to any ingredient in the study medication.
• People who may be dependent on or closely connected to the trial investigators or the company running the study.
• People with a significantly elevated level of a muscle enzyme called creatine phosphokinase (CPK) in their blood (confirm with trial site for exact threshold).
• People with reduced bone density (osteopenia) or another documented bone disease — although people taking vitamin D or calcium supplements for prevention who do not have a confirmed bone disease diagnosis may still be eligible (confirm with trial site).
• For participants at centres where MRI scanning is included: people with severe claustrophobia that prevents them from tolerating an MRI scan (sedation may be allowed at the doctor's discretion), or people with certain metal implants or devices in their body that are not compatible with MRI scanning.

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