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

NCT07143968 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
  • HIV (Human Immunodeficiency Virus)

Interventions

DRUG

Resmetirom

Resmetirom - 80mg or 100mg based on participant weight

DRUG

Placebo Control

Placebo - an identical looking tablet with no medicinal properties

Sponsors & Collaborators

  • Naga P. Chalasani

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-23
Primary Completion
2027-10-31
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07143968 on ClinicalTrials.gov