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:

• People who are 18 years of age or older.
• People whose liver enzyme levels (AST) are at or above a certain level when tested at screening.
• People whose liver stiffness, measured by a special scan called FibroScan, is at or above a certain threshold.
• People who have been diagnosed with a liver condition called NASH (a type of fatty liver disease with inflammation), confirmed by a liver biopsy showing a specific level of disease activity across three areas: fat in the liver, inflammation, and liver cell damage. A recent biopsy done within 6 months before the trial starts may be accepted instead of a new one.
• People whose liver biopsy also shows liver scarring (fibrosis) at a moderate level — specifically Stage 1, 2, or 3 out of 4.
• People who have at least 2 of the following metabolic conditions: a large waist measurement (over 88 cm for women or over 102 cm for men); high triglyceride (fat) levels in the blood, or taking medication for this; low "good" (HDL) cholesterol; a history of high blood pressure that is currently under control; or elevated fasting blood sugar levels.
• People whose liver is still functioning at an acceptable level, shown by specific blood test results at screening (covering protein levels, clotting, and bilirubin).
• People whose blood counts and kidney function meet specific minimum levels at screening (covering white blood cells, platelets, and kidney filtration rate).
• Women who are not able to become pregnant — either due to permanent sterilisation or because they have gone through menopause (no periods for at least one year, confirmed by hormone levels).
• Men who agree not to donate sperm during the study and for at least 90 days after finishing the study medication, and who agree to use condoms throughout the trial and for 3 months after if their partner is fertile or pregnant.
• People who are taking herbal supplements, homeopathic products, or other alternative treatments, provided the dose and routine have been stable for at least 3 months before joining.
• People who understand the trial and are willing to provide written consent to take part.
• People who are willing to undergo 2 liver biopsies during the study.
• People who are willing to attend all scheduled visits, follow the treatment plan, and complete all required tests and procedures.

Who may not be able to join:

• People who have signs of advanced liver disease (cirrhosis), such as fluid build-up in the abdomen, confusion caused by liver failure, or other related symptoms.
• People who have another active liver disease, such as autoimmune hepatitis, hepatitis B or C, alcohol-related liver disease, or liver cancer.
• People whose blood tests at screening show positive markers for viral hepatitis or HIV.
• People who have lost more than 5% of their body weight in the 3 months before the trial begins.
• People who have had weight-loss (bariatric) surgery within the past 5 years.
• People who have a type of diabetes other than Type 2 diabetes.
• People with diabetes whose blood sugar control (measured by HbA1c) is above 9.0%.
• People for whom a liver biopsy procedure would not be safe.
• People whose average daily alcohol intake exceeds recommended limits — more than 20 grams per day for women or 30 grams per day for men, based on a standard questionnaire.
• People currently taking high-dose Vitamin E (800–1000 IU or more per day), or certain diabetes medications including GLP-1 receptor agonists (such as sitagliptin or exenatide), pioglitazone, or SGLT2 inhibitors ("gliflozin" drugs) — unless the dose has been stable for at least 3 months (confirm with trial site).
• People with active rheumatoid arthritis who are currently being treated with, or have been treated within the past year with, certain disease-modifying medications including methotrexate or biologic therapies.
• People currently using or who have used within the past year any immunosuppressive medications, anti-inflammatory antibody treatments, or steroid medications above a certain dose.
• People who have taken certain specific medications — including valproic acid, tamoxifen, amiodarone, or anti-cholinergic agents — for more than 7 days within the 3 months before joining.
• People with thyroid disease that is not well controlled.
• People with uncontrolled high blood pressure, moderate-to-severe heart failure, or other heart conditions considered clinically unstable by the treating doctor.
• People who have had a heart attack, stroke, chest pain (angina), certain surgeries on heart or leg arteries, a mini-stroke (TIA), or a blood clot in the lungs within the past 3 months.
• People whose heart's electrical activity (measured by an ECG) shows a specific abnormality in the QT interval — above a set threshold for both men and women.
• People who have certain conditions that may increase the risk of dangerous heart rhythm problems, including low potassium, low magnesium, or a genetic condition called Long QT Syndrome.
• People who are currently taking or planning to take any medication listed on a recognised database as known to cause a serious heart rhythm problem called Torsades de Pointes.
• People with active digestive system conditions that could affect how oral medication is absorbed by the body.
• People with any serious medical or psychiatric condition, or significant abnormal test results, that the trial team determines would make participation unsafe or unsuitable.

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