A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV

Exclusion Criteria

• •1. History of significant alcohol consumption (defined as \>2 drinks/day on average for men, \>1 drinks/day on average for women) for at least 3 consecutive months (12 consecutive weeks) within 5 year before screening
• •2. History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B virus (HBV), and ongoing or recent (within the past 3 years) hepatitis C RNA positivity.
• •3. History of liver transplant.
• •4. Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
• •5. Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.
• •6. Inability to undergo MRI testing
• •7. Uncontrolled T2DM defined as glycated hemoglobin (HbA1c) \>9.5% at screening.
• •8. Any of the following laboratory values at screening:
• •1. ALT or AST \>250 U/L.
• •2. Total bilirubin (TBL) \>1.5 mg/dL and direct bilirubin \> 0.5 mg/dL (unless due to Gilbert's disease or atazanavir use, per the opinion of the site investigator).
• •3. Platelet count \<150,000/mm3.
• •4. Estimated glomerular filtration rate (e-GFR) \<60 mL/min/1.73m2 using the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation
• •5. International normalized ratio (INR) \>1.3.
• •6. Albumin \< 3.6 g/dL
• •9. Liver stiffness measurement (LSM) by VCTE \> 20 kPa