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:

• Adults between 18 and 85 years of age.
• People who have been diagnosed with non-alcoholic fatty liver disease (a condition where fat builds up in the liver, not caused by alcohol) by their doctor.
• People with a body mass index (a measure of body weight relative to height) between 27 and 40.
• People who have had a liver stiffness scan (called a Fibroscan®) in the last 6 months showing a result greater than 9.2 kPa, which suggests some liver stiffness.

Who may not be able to join:

• People with any other medical condition that, in the opinion of the trial doctor, could affect the study results or the person's ability to take part.
• People with significant heart problems, such as reduced heart pumping ability, moderate-to-severe heart failure, serious heart valve disease, heart attack or angina, unstable heart rhythm problems, or a history of atrial fibrillation (an irregular heartbeat).
• People with significantly reduced kidney function, as measured by a specific blood test at the screening visit.
• People who drink more than 30 grams of alcohol per day (if male) or more than 20 grams per day (if female) (confirm with trial site for what these amounts mean in standard drinks).
• People with significantly impaired liver function, shown by repeated abnormal blood test results (liver enzymes and bilirubin more than three times the normal upper limit).
• People who test positive for hepatitis B or hepatitis C infections.
• People who have liver cancer (hepatocellular carcinoma).
• People with liver cirrhosis (severe liver scarring), indicated by a Fibroscan® result above 18, a compatible liver biopsy, or a history of serious complications from cirrhosis.
• People who have been diagnosed with HIV.
• People who have had an allergic reaction or severe sensitivity to the study supplement (vitamin B3/NAM) or any of its capsule ingredients.
• People with an allergy to iodinated contrast agents (a type of dye used in some medical imaging tests).
• People with a significant autoimmune condition (where the immune system attacks the body), or those who require long-term use of steroid or immune-suppressing medications.
• People currently taking medications that can be harmful to the liver, such as certain heart, immune-suppressing, anti-HIV, anti-tuberculosis, or steroid drugs.
• People using recreational drugs or psychoactive substances that can damage the liver.
• People with a severely disabling illness or significant cognitive impairment (serious difficulties with memory or thinking).
• People living in an institution or without a fixed home address.
• People where the trial doctor has concerns about their likelihood of following the trial requirements or attending follow-up visits.
• People with a life expectancy of less than 12 months.
• People currently participating in another interventional clinical trial, or who have done so within the 30 days before this study starts.
• People who have previously used vitamin B3 (NAM) unless they have stopped taking it for at least 3 months before screening.
• People who are pregnant, or women of childbearing potential who are not using a highly effective form of contraception (such as hormonal contraceptives or an intrauterine device) throughout the study.
• People who are currently breastfeeding.
• People currently taking vitamin E supplements or as part of treatment.
• People currently taking probiotic supplements.
• People scheduled for weight-loss (bariatric) surgery within the next 12 months.
• People taking medications that may affect the progression of liver disease.
• People who started certain diabetes medications that affect the liver or gut bacteria (including GLP-1 analogues, pioglitazone, metformin, or certain other diabetes drug types) within the 6 months before the study starts (confirm with trial site for the full list).
• People who do not sign the informed consent form agreeing to take part.
• People with known contraindications (medical reasons to avoid) the contrast agent used in the imaging tests involved in the study.

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