RecruitingPhase 2NCT07143968

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Resmetirom for the Treatment of Metabolic Dysfunction- Associated Steatotic Liver Disease (MASLD) in People Living With Human Immunodeficiency Virus (HIV)


Sponsor

Naga P. Chalasani

Enrollment

120 participants

Start Date

Apr 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo Control and a drug called Resmetirom for people with hiv (human immunodeficiency virus) and masld - metabolic dysfunction-associated steatotic liver disease. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGResmetirom

Resmetirom - 80mg or 100mg based on participant weight

DRUGPlacebo Control

Placebo - an identical looking tablet with no medicinal properties


Locations(10)

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

Indiana University

Indianapolis, Indiana, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07143968


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