The purpose of this research study is to test the safety and effectiveness of the study drug, resmetirom, in participants with MASLD and HIV. This is a research study to test a drug that is already on the market with a population that was not included in the original clinical trials. Participants will be people over age 18 with HIV who are on antiretroviral therapy and have been diagnosed with MASLD. Researchers will compare resmetirom to placebo (a look-alike substance that contains no drug) to see if resmetirom decreases the amount of fat in the liver. Participants will: * Complete 3 screening visits to determine eligibility. * Take resmetirom or placebo every day for 24 weeks if eligible. * Have 2 MRI scans to measure the amount of fat on the liver. One will be before treatment starts and one will be at the end of 24 weeks of treatment. * Attend 3 scheduled clinic visits while on treatment for bloodwork and safety assessments. * Participate in 3 phone calls while on treatment and one phone call 4 weeks after treatment is completed to check for safety and any health changes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Resmetirom - 80mg or 100mg based on participant weight
Placebo - an identical looking tablet with no medicinal properties
University of Alabama Birmingham
Birmingham, Alabama, United States
UC San Diego Altman Clinical and Translational Research Institute
La Jolla, California, United States
University of California, San Francisco
San Francisco, California, United States
Atlantic Clinical Research Institute
West Palm Beach, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mt Sinai Health System
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
UT Health Houston
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Change from baseline in hepatic fat content at week 24
Time frame: From baseline to the end of treatment at 24 weeks
Proportion of participants with reduction of at least 30% in hepatic fat content from baseline to week 24
Time frame: Baseline to the end of treatment at week 24
Change from baseline in liver enzyme parameters, lipid profile and fasting glucose
Time frame: From baseline to end of treatment at week 24
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