Phase 3 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 between 19 and 70 years old at the time of screening
• People who have been diagnosed with alcoholic or non-alcoholic fatty liver disease
• People whose ALT liver enzyme level (a measure of liver health) falls between 60 and 200 IU/L at the time of screening
• People who are able to sign a consent form and follow the requirements of the trial

Who may not be able to join:

• People who have had liver cancer or any other type of cancer in the past 5 years
• People who have had serious liver-related complications — such as bleeding from the oesophagus, liver-related confusion, or fluid build-up in the abdomen — within the past year, or whose liver function is rated as Class B or C on a medical scoring scale (confirm with trial site)
• People who have had an organ or bone marrow transplant
• People with certain liver conditions, including bile duct blockages present from birth, inherited liver diseases, sudden severe liver failure, liver damage from toxins, certain types of hepatitis, or bleeding or platelet disorders
• People with immune system-related liver conditions, such as autoimmune hepatitis, primary biliary cirrhosis, or certain bile duct diseases
• People who have had weight-loss (bariatric) surgery within the past 24 weeks
• People with poorly controlled diabetes (based on a blood sugar marker called HbA1c being above 9.0%)
• People with serious, uncontrolled heart or lung disease
• People who have had an alcohol misuse problem within the past 5 years
• People with active Hepatitis B or C virus infection — though people with Hepatitis B whose virus is undetectable, or Hepatitis C patients who have achieved a sustained viral response after antiviral treatment, may be eligible (confirm with trial site)
• People with an active widespread infection, including tuberculosis
• People currently taking certain liver-support medicines (hepatotonics), unless a sufficient break from those medicines has been observed before joining: 14 days for Biphenyl dimethyl dicarboxylate (BDD) or Silymarin (Milk thistle); 30 days for Ursodeoxycholic acid (UDCA); or a period equal to 5 times the medicine's half-life for other liver-support medicines
• People who are taking, or who would need to take during the trial, certain medicines — including anti-tuberculosis drugs, antifungal agents, antibiotics, paracetamol (acetaminophen), anti-inflammatory drugs (NSAIDs, excluding low-dose aspirin for prevention), certain cholesterol-lowering or blood sugar-lowering medicines (unless the dose has been stable and will remain unchanged throughout the trial), certain blood pressure medicines (unless the dose has been stable and will remain unchanged throughout the trial), high-dose Vitamin E (above 800 IU/day for treatment purposes), oestrogens, corticosteroids, or immune-modifying medicines
• People who regularly drink more alcohol than the recommended limits (more than 40 g per day for men or 20 g per day for women)
• People who have previously had allergic reactions to medicines, such as shaking, fever, or itching
• People who have taken part in another clinical drug trial within the 4 weeks before screening
• People who are unable to receive an intravenous (drip) infusion of 5% Dextrose solution
• People who are pregnant, breastfeeding, or women of childbearing age who are not using an adequate form of contraception (accepted methods include surgical sterilisation, an intrauterine device, condoms, or spermicide)
• People the trial investigators consider unsuitable for any other reason

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