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 aged 18 to 75 years who are able to give written consent and follow the study requirements
• People with a suspected diagnosis of a liver condition called MASH, confirmed either by a liver biopsy taken within the last 6 months showing certain scores, or by a liver scan result above a specific level combined with metabolic risk factors
• People with confirmed fat build-up in the liver, shown by two types of scans (FibroScan® and MRI) meeting specific measurement ranges at the screening stage
• People with a body mass index (BMI) between 25 and 50 (or between 23 and 50 for people of Asian background)
• People with a liver enzyme level called ALT at or above 60 U/L at the first screening visit, with stable liver enzyme levels throughout the screening period
• People whose kidneys are functioning at or above a certain level, based on a standard kidney function calculation (confirm with trial site)
• People whose body weight has been stable, with no more than 5% change, for at least 6 months before screening
• People willing to follow the contraception requirements set out by the trial, where applicable
• People the investigator considers able to safely complete all required scans and tests

Who may not be able to join:

• People with a liver disease other than MASH or its related condition (MASLD), such as alcohol-related liver disease, autoimmune hepatitis, or drug-related liver damage
• People with advanced liver scarring (cirrhosis), based on biopsy, imaging, or scan results showing signs such as liver shape changes, fluid build-up, enlarged spleen, or a history of swollen veins in the food pipe
• People with liver enzyme levels (ALT, AST, or ALP) that are significantly above the normal range at screening
• People with thyroid or adrenal gland conditions that are not well controlled, such as underactive or overactive thyroid
• People with Type 1 diabetes, a blood sugar control measure (HbA1c) above 9.5%, or unstable Type 2 diabetes that required medication changes within the past 90 days
• People who have recently used certain medications that affect liver fat or scarring — including some diabetes medications, high-dose vitamin E, or liver-affecting drugs — unless they have been off them for a set period (confirm with trial site)
• People with significant alcohol use in the year before screening
• People who have recently experienced a serious heart event, such as a heart attack, stroke, unstable chest pain, significant heart failure, or an uncontrolled irregular heartbeat
• People with a current or recent serious psychiatric condition, including psychosis, active thoughts of suicide, or a suicide attempt within the past 5 years
• People who are pregnant or breastfeeding, or who have conditions that could make MRI scans unsafe or interfere with study procedures

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