A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV (NCT07143968) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
United States120 participantsStarted 2026-04-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults (≥18 years of age) with documented HIV.
. Documented diagnosis of MASLD established by imaging (ultrasound, CT scan or MRI) or vibration-controlled transient elastography (VCTE) or liver biopsy within 12 months before screening.
. Hepatic fat fraction ≥8% by MRI-PDFF.
. Liver stiffness by VCTE ≥8 kPa and CAP≥263 dB/m
. HIV-1 RNA \<200 copies/mL for ≥6 months on antiretroviral therapy (ART) (must have screening HIV-1 RNA value and one clinical care value within 6 months prior to screening and up to the randomization that meet the criteria).
. Stable ART regimen for ≥3 months prior to screening and stable up to the randomization and no active plans to change ART while on study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Resmetirom is already FDA-approved for liver disease in the general population, but this is a Phase 2 trial specifically in people with both MASLD and HIV — what is still unknown about how it works or how safe it is for someone in my situation with HIV?
2This trial measures changes in liver fat over 24 weeks, but it doesn't seem to be measuring long-term outcomes like cirrhosis or liver failure yet — does that mean we won't know whether reducing liver fat actually translates into better health outcomes for me?
3Could any of my current HIV medications interact with resmetirom, and is that part of what this trial is trying to understand?
4Given that this is only Phase 2, would my doctor recommend I try any currently available standard-of-care approaches for MASLD first, before considering enrolling in this trial?
5What would participating in this trial actually look like day-to-day — how many visits, tests, or restrictions would be involved over the 24 weeks, and how might that fit with managing my HIV care at the same time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in hepatic fat content at week 24
Timeframe: From baseline to the end of treatment at 24 weeks
. History of significant alcohol consumption (defined as \>2 drinks/day on average for men, \>1 drinks/day on average for women) for at least 3 consecutive months (12 consecutive weeks) within 5 year before screening
. History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B virus (HBV), and ongoing or recent (within the past 3 years) hepatitis C RNA positivity.
. History of liver transplant.
. Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
. Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.
. Inability to undergo MRI testing
. Uncontrolled T2DM defined as glycated hemoglobin (HbA1c) \>9.5% at screening.
. Any of the following laboratory values at screening: