MASH, or Metabolic Dysfunction-Associated Steatohepatitis, is a chronic liver disease. It is most common in people who are obese and/or have Type 2 diabetes. MASH is caused by the buildup of fat in the liver leading to inflammation and damage. If left untreated, MASH can cause scarring (fibrosis) and eventually cirrhosis can occur, which obstructs the liver’s ability to function properly.

There is currently no approved treatment or therapy for MASH cirrhosis, but studies like this one are working to change that.

You may be eligible for this study if you meet the following criteria.

Inclusion Criteria:

• Adults with type 2 diabetes OR experiencing at least two of the following metabolic risk factors:

  • Obesity

  • High cholesterol or lipid problems, or take medication to lower cholesterol

  • High blood pressure (hypertension), or take medication for blood pressure

  • Body Mass Index (BMI) between 25 and 50

  • Liver disease related to fatty liver (NASH) with compensated cirrhosis

• Diagnosed with type 2 diabetes at least 3 months ago, if applicable

• Ages 18-75

Exclusion Criteria:

• History of liver disease other than NASH

• Have had, or are planning to have, a liver transplant

• History of hepatocellular carcinoma (HCC)

• History of cancer within the past 5 years

• History of alcohol use disorder and continued drinking alcohol in the past 12 months

• History of large or moderate swollen veins in the throat or stomach

The screening period may last up to 12 weeks to determine if you are eligible to participate. During this period, you may be required to return to the study site up to four additional times, depending on the results of tests. You will be asked to sign the informed consent form before any study procedures can begin.

During visits, blood and urine samples will be collected. You will have abdominal imaging done as part of the study, in addition to a liver biopsy. You will have study health checks about every 2 to 3 months for the first year, then alternate phone calls and visits every 3 months for 4 more years. You will follow instructions for diet, activity level, and alcohol use throughout the study.

For your time and inconvenience related to participating in this study, you will receive $85 for each in-person study visit you complete (up to 16 visits). If applicable, you will receive $170 for each imaging procedure you complete, including DEXA scans, ultrasounds, FibroScans, and MRI-PDFF scans. You will receive $400 for each liver biopsy you complete, if applicable, and $300 for each upper endoscopy (EGD) you complete, if applicable. The total possible compensation for completing all eligible study procedures is up to $7,800.

There is no cost for you to participate in our research study.