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:

• People who are willing to take part and sign a consent form agreeing to participate.
• People aged 18 to 74 years old at the time of signing the consent form.
• People who have had a liver biopsy within the past 180 days showing a specific level of liver scarring (fibrosis stage 1 to 3) and signs of liver damage meeting certain scoring thresholds (confirm with trial site).
• People whose liver fat content has been measured at 10% or more using a specific type of MRI scan.
• People whose body weight has changed by no more than 5% in the six weeks before joining the trial.
• People whose doses of certain medications have been stable for a set period — including diabetes medications (GLP-1 or SGLT2 type) for at least 3 months, high-dose Vitamin E (400 IU/day or more) for at least 6 months, and cholesterol-lowering medications (statins) for at least 3 months.
• Women who could become pregnant must use a highly effective form of contraception throughout the study and for 6 months after finishing treatment.

Who may not be able to join:

• People who have a chronic liver disease caused by something other than NASH (non-alcoholic steatohepatitis).
• People with Type 1 diabetes, or Type 2 diabetes that is not well controlled (based on specific blood sugar test results at screening).
• People with high blood pressure that is not well controlled, measured at 160/100 mmHg or above at screening.
• People who have had or currently have cirrhosis (advanced liver scarring).
• People with an active cancer, or a history of most cancers that have not been fully cleared for more than 5 years (some exceptions apply — confirm with trial site).
• People who are unwilling or unable to have a liver biopsy as required by the study.
• People who have had weight-loss surgery within the past 5 years.
• People who had major surgery within 3 months before signing the consent form, or who have major surgery planned during the study.
• People who have had a bone injury, fracture, or bone surgery within the past 2 months.
• People whose bone density scan at screening shows results meeting the definition of osteoporosis (T-score of -2.5 or lower).
• People with a recent history of drug misuse within the past 2 years.
• People who have taken part in another clinical trial of a drug or medical device within the past 3 months.
• People with certain abnormal blood test results at screening, including elevated liver enzymes, reduced kidney function, or abnormal clotting or platelet levels (confirm with trial site for specific thresholds).
• People who are pregnant or breastfeeding.
• People who have had a liver transplant or have one planned.
• People who cannot have an MRI scan for any reason.
• People who have any other condition that, in the opinion of the study doctor, could affect their safety or ability to complete the trial.

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