StudyFinder
A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
RECRUITING
18 years and over
Inclusion Criteria:
• Adults (≥18 years of age) with documented HIV.
• Documented diagnosis of MASLD established by imaging (ultrasound, CT scan or MRI) or vibration-controlled transient elastography (VCTE) or liver biopsy within 12 months before screening.
• Hepatic fat fraction ≥8% by MRI-PDFF.
• Liver stiffness by VCTE ≥8 kPa and CAP≥263 dB/m
• HIV-1 RNA \<200 copies/mL for ≥6 months on antiretroviral therapy (ART) (must have screening HIV-1 RNA value and one clinical care value within 6 months prior to screening and up to the randomization that meet the criteria).
• Stable ART regimen for ≥3 months prior to screening and stable up to the randomization and no active plans to change ART while on study.
• Willingness to participate in the study.
Exclusion Criteria:
• 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
• 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.
• History of liver transplant.
• Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
• Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.
• Inability to undergo MRI testing
• Uncontrolled T2DM defined as glycated hemoglobin (HbA1c) \>9.5% at screening.
• Any of the following laboratory values at screening:
• ALT or AST \>250 U/L.
• 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).
• Platelet count \<150,000/mm3.
• Estimated glomerular filtration rate (e-GFR) \<60 mL/min/1.73m2 using the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation
• International normalized ratio (INR) \>1.3.
• Albumin \< 3.6 g/dL
• Liver stiffness measurement (LSM) by VCTE \> 20 kPa
• Further exclusion criteria apply
DRUG: Resmetirom, DRUG: Placebo Control
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, HIV (Human Immunodeficiency Virus)
Holly Crandall, BSN - hrking1@iu.edu
NCT07143968