Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-05-07
notable Primary completion pushed: 2027-09 -> 2027-10 2026-05-07
minor Completion pushed: 2027-10 -> 2027-11 2026-05-07
Trial Details
NCT Number NCT07143968
Lead Sponsor Naga P. Chalasani
Conditions MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, HIV (Human Immunodeficiency Virus)
Enrollment 120 participants
Start Date 2026-04-23
Primary Completion 2027-10 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-30