Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

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 between 18 and 70 years old (inclusive) of any gender.
• People who have had a liver biopsy within the past 6 months showing a diagnosis of NASH (a type of fatty liver disease) with a disease activity score of 4 or higher and a specific level of liver scarring (F1–F3), OR people who have had a liver scan (MRI) within the past 3 months showing that at least 10% of the liver is made up of fat.
• People who are able to have children, and their partners, who agree to use effective contraception from the screening period until at least 3 months after the last dose of the study drug.
• People with stable liver enzyme levels (ALT and AST) before the study begins, confirmed according to specific testing requirements set out by the trial (confirm with trial site).
• People who are able to avoid strenuous exercise for at least 24 hours before each study visit or blood draw.
• People who are willing to sign a consent form and are able to complete all study requirements as outlined in the protocol.

Who may not be able to join:

• People who have, or have had, a significant liver or bile duct disease other than NASH — such as hepatitis B, untreated hepatitis C, alcohol-related liver disease, autoimmune hepatitis, or certain other liver conditions — if the research team considers this a reason not to participate.
• People who have a history of liver cirrhosis (severe liver scarring).
• People who have primary liver cancer, or who have a specific liver cancer marker (AFP) above a certain level in their blood test.
• People who have a known allergy to any ingredient in the study drug.
• People who have had surgery that may affect how the treatment works, such as weight loss surgery or a liver transplant.
• People who have been diagnosed with a malignant (cancerous) tumour within the past 5 years.
• People who cannot have an MRI scan for any reason.
• People with a history of drug or substance misuse within the past 2 years.
• People who have drunk heavily for more than 3 consecutive months in the year before screening.
• People whose body weight has changed by 5% or more in the 3 months before randomisation, or by 10% or more in the 6 months before randomisation.
• People who have donated blood within the past 3 months, or who have lost 400 mL or more of blood (through donation or any other reason) in the past 6 months.
• People who have had serious heart conditions or heart-related procedures within recent months, including unstable chest pain, a heart attack, life-threatening irregular heartbeat, or certain heart surgeries within the past 3–6 months, or who have significant heart failure.
• People with Type 1 diabetes, poorly controlled Type 2 diabetes (as measured by a specific blood test result), or a history of severe low blood sugar episodes.
• People with a bowel condition that affects how oral medications are absorbed.
• People with thyroid disease (overactive or underactive thyroid) or pituitary gland disorders.
• People with serious conditions affecting the circulation, breathing, urinary system, blood, immune system, mental health, nervous system, or kidneys, where the research team considers participation unsuitable.
• People with blood pressure that remains too high (above 160/100 mmHg) even when taking regular medication.
• People with a certain abnormality on their heart tracing (ECG) at screening (confirm with trial site).
• People who test positive for HIV or syphilis at screening.
• People who are pregnant or breastfeeding.
• People whose blood test results at screening fall outside acceptable ranges for platelet count, bilirubin, liver enzymes, kidney function, a clotting measure (INR), thyroid hormone levels, or a heart marker called cardiac troponin (confirm with trial site for specific thresholds).
• People who have not been on a stable dose of certain diabetes medications (such as SGLT2 inhibitors or PCSK9 inhibitors) for at least 6 months before randomisation, unless specific stability conditions are met.
• People who have used high-dose vitamin E, pioglitazone, GLP-1 receptor agonists, or certain combination diabetes drug regimens within the past 6 months.
• People who have received specific NASH or fatty liver treatments (such as FXR agonists, FGF21 analogues, or similar drugs) within the past 3 months.
• People who have not been on a stable dose of blood sugar–lowering medications (other than those listed separately) for at least 3 months before randomisation.
• People whose insulin dose has changed by 30% or more in the past 3 months.
• People who have not been on a stable dose of cholesterol-lowering medications for at least 3 months before randomisation.
• People who have participated in another clinical trial of an experimental drug or device within the past 3 months (or within 5 half-lives of that drug, whichever is longer), unless they received no active treatment in that trial.
• People who have taken certain medications known to cause or worsen fatty liver disease — such as amiodarone, methotrexate, long-term steroids, tamoxifen, anabolic steroids, or valproic acid — for at least 2 weeks in the month before joining the study.
• People who have used certain liver-protective herbal or pharmaceutical preparations not permitted by the trial protocol within the past 4 weeks (confirm with trial site for the specific list).
• People who have received blood-thinning medications (anticoagulants such as warfarin or heparin) within 2 weeks before randomisation.
• People who have taken certain medications that significantly affect how the liver breaks down drugs (strong CYP3A inhibitors or inducers, or certain drug transporter inhibitors) within 14 days before randomisation or within 5 half-lives of those drugs, whichever is longer.
• People whom the research team considers unsuitable for any other reason.

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