A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV (NCT07143968)
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Resmetirom for the Treatment of Metabolic Dysfunction- Associated Steatotic Liver Disease (MASLD) in People Living With Human Immunodeficiency Virus (HIV)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (17 items).
Location: University of Alabama Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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:
- ALT or AST \>250 U/L.
- Total bilirubin (TBL) \>1.5 mg/dL and direct bilirubin \> 0.5 mg/dL (unless due to Gilbert's disease or atazanavir use, per the opinion of the site investigator).
- Platelet count \<150,000/mm3.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (10 Sites)
- University of Alabama Birmingham — Birmingham, Alabama
- UC San Diego Altman Clinical and Translational Research Institute — La Jolla, California
- University of California, San Francisco — San Francisco, California
- Atlantic Clinical Research Institute — West Palm Beach, Florida
- Indiana University — Indianapolis, Indiana
- Johns Hopkins University — Baltimore, Maryland
- Mt Sinai Health System — New York, New York
- Duke University Medical Center — Durham, North Carolina
- UT Health Houston — Houston, Texas
- Virginia Commonwealth University — Richmond, Virginia
📞 Contact the Study Coordinator
Phone: (317) 278-6200
Email: hrking1@iu.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Effect of Ketone Esters on Liver Fat Content and Metabolic Function — St Louis, Missouri
- Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis — Seattle, Washington
- Screening Cardiometabolic Opportunities Using Transformative Echocardiography Artificial Intelligence (SCOUT Echo-AI) — Los Angeles, California
- Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity — San Francisco, California
- Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study — San Francisco, California
Explore by condition: All MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.