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:

For people with fatty liver disease (main study):

• Adults aged 18 or older
• People who have had a liver biopsy in the past 12 months showing fat in the liver, OR have had an imaging scan (such as ultrasound, CT, or MRI) in the past 12 months showing fatty liver disease
• People whose average alcohol intake has been below a moderate threshold (less than 30g per day for men, or less than 20g per day for women) over the past 6 months, with no binge-drinking
• People who are able to understand the study and are willing to sign a consent form
• People whose liver biopsy at the start of the study confirms a certain level of fat in the liver (confirmed at trial entry)
• People whose liver fat content measured by a specific MRI scan is 10% or higher at the start of the study (confirmed at trial entry)

For healthy volunteers (a separate group in the trial):

• Adults aged 18 or older
• People with no signs of fat in the liver on imaging or biopsy, and no known liver disease history
• People with a body mass index (BMI) of 25 or below
• People who do not have diabetes
• People with normal liver enzyme levels on blood tests
• People with a normal fasting blood sugar level
• People on regular medications may be considered, with eligibility determined by the lead researcher
• People able to understand the study and willing to sign a consent form

Who may not be able to join:

For people with fatty liver disease (main study):

• People who are pregnant or breastfeeding
• People with a current hepatitis C (HCV) or hepatitis B (HBV) infection, or who are currently on antiviral treatment; people previously treated successfully for hepatitis C may be considered if it has been more than 18 months since treatment ended
• People with HIV infection
• People with other liver conditions such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis
• People whose liver damage is likely caused by a medication they are taking, unless the relevant medication has been associated with stable liver enzyme levels for at least 6 months
• People with severely advanced liver disease, based on specific blood test results or a history of serious complications such as fluid build-up in the abdomen, confusion caused by liver failure, bleeding from enlarged veins in the oesophagus, serious abdominal infections, or a previous liver transplant
• People currently taking certain medications known to cause fatty liver, such as some antipsychotics, tetracycline, methotrexate, or tamoxifen
• People with thyroid levels that are not well controlled
• People with certain types of thyroid nodules that show features possibly associated with a higher risk of thyroid cancer on ultrasound, or nodules linked to an abnormal thyroid hormone level
• People with active coronary artery disease (ongoing chest pain or signs of reduced blood flow to the heart); people previously treated for coronary artery disease with surgery or a procedure may be considered if they have had no active disease for at least one year, can safely pause blood-thinning medications, and have adequate heart function — but would require clearance from a heart specialist first (confirm with trial site)
• People with congestive heart failure
• People with chronic kidney disease where kidney filtering function falls below a certain level
• People with poorly controlled diabetes (HbA1c above 9%); people with diabetes may be considered if their HbA1c is 9% or below, they have been on a stable treatment plan using lifestyle changes and/or metformin for at least 3 months, and no changes to their diabetes medications are expected during the trial
• People currently using insulin, sulfonylureas, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors, unless these were stopped at least 3 months before joining
• People for whom a liver biopsy is not safe or not possible, including those with blood clotting problems, low platelet counts, abnormal bleeding, or a haemoglobin level below 11 g/dL
• People who cannot have an MRI scan, such as those with certain metal implants, pacemakers (unless MRI-safe), insulin pumps, implanted hearing aids, neurostimulators, metal clips in the brain, metal fragments in the eyes, metal hip replacements, or severe claustrophobia
• People who have had gastric bypass or other weight-loss surgery, partial or full stomach removal, or who have known problems absorbing nutrients
• People currently taking orlistat (a weight-loss medication)
• People with uncontrolled eating disorders such as anorexia or bulimia
• People with advanced diabetic eye disease (proliferative diabetic retinopathy)
• People currently taking medications or supplements specifically to treat fatty liver disease, unless these were stopped at least 3 months before joining, or have been taken at a stable dose for at least 6 months
• People who have had a liver biopsy within the past 2 years, unless they are fully willing to undergo all research biopsies required by the trial, understanding these are for research purposes only and are not medically necessary
• People who are unwilling or unable to receive injections under the skin
• People with a known or suspected allergy to the trial medication or its ingredients
• People with a history of alcohol or substance misuse in the past 12 months
• Women of childbearing potential who are pregnant, breastfeeding, or unwilling to use contraception for the full duration of the study
• People who personally have, or have a close family member with, a history of a specific type of thyroid cancer called medullary thyroid carcinoma, or a condition called multiple endocrine neoplasia type 2 (MEN-2)
• People who are actively following a different diet or exercise programme aimed at losing more than 10% of their body weight, or who have lost more than 10% of their body weight in the past 3 months
• People who have taken part in another clinical trial involving an experimental drug within the past 3 months
• People whom the lead researcher considers unlikely to complete the study, or for whom participation would carry significant risk

For healthy volunteers (a separate group in the trial):

• People who are pregnant or breastfeeding
• People who drink, on average, more than one alcoholic drink per day over the past month
• People whom the lead researcher considers unsuitable for participation or at significant risk

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