Actively Recruiting
A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
Led by Naga P. Chalasani · Updated on 2026-05-06
120
Participants Needed
10
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years of age or older) with documented HIV.
- Diagnosis of MASLD confirmed by imaging (ultrasound, CT scan, MRI) or vibration-controlled transient elastography (VCTE) or liver biopsy within 12 months before screening.
- Hepatic fat fraction of 8% or higher by MRI-PDFF.
- Liver stiffness by VCTE of 8 kPa or higher and controlled attenuation parameter (CAP) of 263 dB/m or higher.
- HIV-1 RNA less than 200 copies/mL for at least 6 months on antiretroviral therapy.
- Stable antiretroviral therapy regimen for at least 3 months prior to screening with no plans to change during the study.
- Willingness to participate in the study.
You will not qualify if you...
- Significant alcohol consumption (more than 2 drinks/day for men or more than 1 drink/day for women) for at least 3 consecutive months within 5 years before screening.
- History of other acute or chronic liver diseases including autoimmune liver disease, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B, or recent hepatitis C infection within the past 3 years.
- History of liver transplant.
- Liver biopsy or imaging showing cirrhosis or portal hypertension at screening.
- Visit 2 liver enzyme values (ALT, AST, ALP) exceeding Visit 1 values by more than 50%.
- Inability to undergo MRI testing.
- Uncontrolled type 2 diabetes with HbA1c over 9.5% at screening.
- Abnormal laboratory values at screening including ALT or AST over 250 U/L, total bilirubin over 1.5 mg/dL (except Gilbert's disease or atazanavir use), platelet count below 150,000/mm3, estimated glomerular filtration rate below 60 mL/min/1.73m2, INR over 1.3, or albumin below 3.6 g/dL.
- Liver stiffness measurement by VCTE over 20 kPa.
- Further exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Not Yet Recruiting
2
UC San Diego Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92037
Not Yet Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
4
Atlantic Clinical Research Institute
West Palm Beach, Florida, United States, 33409
Not Yet Recruiting
5
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Not Yet Recruiting
7
Mt Sinai Health System
New York, New York, United States, 10029
Not Yet Recruiting
8
Duke University Medical Center
Durham, North Carolina, United States, 27710
Not Yet Recruiting
9
UT Health Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
10
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Not Yet Recruiting
Research Team
H
Holly Crandall, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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