Testing Resmetirom for Treating Metabolic Dysfunction-Associated Steatotic Liver Disease in Adults With HIV

What this Trial Is About

Researchers are studying the safety and effectiveness of the drug resmetirom in people over 18 years old who have both metabolic dysfunction-associated steatotic liver disease MASLD and HIV. This study focuses on a population with HIV on antiretroviral therapy who were not included in earlier trials of resmetirom. The goal is to compare resmetirom with a placebo to see if it reduces liver fat. Participants will be randomly assigned to receive either resmetirom, dosed at 80mg or 100mg based on weight, or a placebo daily for 24 weeks. The study includes three screening visits to confirm eligibility. Two MRI scans will measure liver fat, one before starting treatment and one after 24 weeks. Participants will also have three clinic visits during treatment for blood tests and safety checks, along with phone calls during and after treatment to monitor health. During the study, participants will complete multiple visits and assessments including MRI scans, bloodwork, and safety monitoring calls. Researchers will measure changes in liver fat and other liver-related markers from baseline to week 24. The primary outcome is the change in liver fat content. Secondary outcomes include reductions in liver fat by at least 30%, changes in liver enzymes, lipid levels, and glucose. Safety will be monitored through scheduled visits and phone contacts over the study duration.

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