Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Trial of Resmetirom for MASLD in People With HIV
Led by Naga P. Chalasani · Updated on 2026-05-06
120
Participants Needed
10
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the drug resmetirom in adults with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) who also have HIV. This Phase 2 study compares resmetirom against a placebo in people living with HIV who are on antiretroviral therapy. The goal is to see if resmetirom can reduce the amount of fat in the liver, a concern for those with MASLD. Participants will be randomly assigned to receive either resmetirom or a placebo every day for 24 weeks. The resmetirom dose will be based on the participant's weight, either 80mg or 100mg. Before starting treatment and at the end of 24 weeks, participants will have MRI scans to measure liver fat. During treatment, they will attend three clinic visits for blood tests and safety checks, and participate in three phone calls plus one additional call four weeks after treatment ends to monitor health and safety. Throughout the study, participants will complete three screening visits to confirm eligibility. Researchers will monitor changes in liver fat content as the primary outcome, along with liver enzyme levels, lipid profiles, and fasting glucose as secondary measures. Safety assessments and bloodwork will be conducted regularly. Participation will last at least 24 weeks of treatment plus follow-up, with ongoing monitoring through scheduled visits and calls.
CONDITIONS
Brief 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
- Diagnosed with MASLD by imaging or biopsy within 12 months before screening
- Hepatic fat fraction 8% or higher by MRI-PDFF
- Liver stiffness and CAP values meeting specific thresholds
- 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
- Willingness to participate in the study
You will not qualify if you...
- History of significant alcohol use exceeding 2 drinks/day for men or 1 drink/day for women for 3 months within 5 years before screening
- Other acute or chronic liver diseases including autoimmune, primary biliary cholangitis, Wilson's disease, alpha-1 antitrypsin deficiency, hemochromatosis, hepatitis B or recent hepatitis C infection
- History of liver transplant
- Evidence of cirrhosis or portal hypertension at screening
- Liver enzyme values increasing by more than 50% between visits
- Inability to undergo MRI testing
- Uncontrolled type 2 diabetes with HbA1c above 9.5%
- Certain abnormal laboratory values including high liver enzymes, low platelets, reduced kidney function, abnormal coagulation, or low albumin
- Liver stiffness measurement above 20 kPa
- Further exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive either Resmetirom or placebo to evaluate the effect on hepatic fat content and liver-related parameters.
Regular visits during the 24-week treatment period
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
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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