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 aged 18 to 75 years old (inclusive)
• People who have had a liver biopsy within the last 6 months (or during the screening process) confirming a specific level of liver disease activity (a NAFLD activity score of 4 or higher, with damage seen across three specific areas of the liver) and a liver scarring (fibrosis) stage of 1 to 3
• People whose liver fat content has been measured at 8% or more using a specific type of MRI scan (MRI-PDFF) during screening
• People who do not drink alcohol, or whose alcohol intake has been below set limits (under 210g of ethanol per week for men, under 140g per week for women) over the past 12 months
• People who have been on a stable dose of any long-term medications (such as blood pressure, cholesterol, or diabetes medicines) for at least 3 months before the qualifying liver biopsy
• People whose weight has been stable (changed by no more than 5%) in the 6 months before screening
• People who have not made changes to their diet or exercise habits in the 3 months before screening
• People who are able to understand what the study involves and are willing to sign a written consent form
• People who are not planning a pregnancy and who are willing to use effective contraception throughout the trial
• People who are willing to follow the trial instructions and cooperate with data collection, as judged by the research team

Who may not be able to join:

• People who have taken certain medications known to cause fatty liver disease (such as valproic acid, tamoxifen, methotrexate, amiodarone, oral steroids above a certain dose, or high-dose oestrogens) for 2 weeks or more at any point in the 12 months before their qualifying liver biopsy
• People whose fatty liver disease has a documented cause other than NASH — for example, a specific strain of hepatitis C, Wilson's disease, autoimmune hepatitis, or certain other liver or digestive conditions
• People with a liver disease severity score (MELD score) above 12 (confirm with trial site)
• People who have advanced liver scarring (fibrosis stage 4/cirrhosis) or who have been diagnosed with liver cancer (hepatocellular carcinoma), either now or in the past
• People who have previously had a liver transplant or who are planning to have one
• People who test positive for hepatitis A, B, C, D, or E
• People with significantly abnormal liver function blood test results, including very high liver enzyme levels (ALT or AST more than 5 times the upper limit of normal), high alkaline phosphatase, low albumin, or elevated bilirubin (unless the person has a documented history of Gilbert's syndrome and their direct bilirubin is within normal range)
• People (who are not on blood thinners) whose blood clotting test result (INR) is 1.3 times the upper limit of normal or higher, or who show other signs of poor clotting
• People with significantly reduced kidney function (eGFR below 30 mL/min/1.73m²)
• People currently receiving any approved treatment specifically for NASH
• People with a blood sugar control marker (HbA1c) of 9% or higher, or a fasting blood glucose above 13.9 mmol/L at screening
• People with a type of diabetes other than type 2 diabetes (for example, type 1 diabetes, drug-induced diabetes, or immune-related diabetes)
• People with a BMI below 23 kg/m² or 40 kg/m² or above
• People who have had weight-loss (bariatric) surgery or tumour surgery within the 5 years before the qualifying liver biopsy
• People with uncontrolled high blood pressure (160/100 mmHg or above) or low blood pressure (below 80/50 mmHg)
• People who have had a serious heart or blood vessel event — such as a heart attack, stroke, worsening peripheral vascular disease, or vascular/cardiac surgery — within the 6 months before screening
• People with a mental health condition that is not well controlled and that may affect their ability to give consent or report side effects
• People who have not had a liver biopsy in the 6 months before screening and who are not willing to have one during the screening process
• People with known allergies to the trial drug or any of its ingredients, or who are known to have a history of significant allergic reactions
• People who are pregnant or breastfeeding
• People who have taken part in another clinical drug trial within the 3 months before screening
• People whom the research team considers unsuitable for the study for any other reason

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