Resmetirom treatment for adults with MASLD and HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 2 trial enrolls adults with MASLD and documented HIV who are on stable antiretroviral therapy. Participants will be assigned to resmetirom or a matching placebo and take the study drug daily for 24 weeks, with MRI-PDFF scans before treatment and at week 24 to measure liver fat. Safety and adherence are monitored with three scheduled clinic visits, three phone calls, and routine bloodwork; eligibility requires hepatic fat ≥8% by MRI-PDFF and HIV-1 RNA <200 copies/mL. The trial is being run at three U.S. academic centers and excludes participants with recent significant alcohol use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults (≥18 years of age) with documented HIV.
2. 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.
3. Hepatic fat fraction ≥8% by MRI-PDFF.
4. Liver stiffness by VCTE ≥8 kPa and CAP≥263 dB/m
5. 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).
6. 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.
7. Willingness to participate in the study.

Exclusion Criteria:

1. 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
2. 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.
3. History of liver transplant.
4. Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
5. Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.
6. Inability to undergo MRI testing
7. Uncontrolled T2DM defined as glycated hemoglobin (HbA1c) \>9.5% at screening.
8. Any of the following laboratory values at screening:

   1. ALT or AST \>250 U/L.
   2. 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).
   3. Platelet count \<150,000/mm3.
   4. Estimated glomerular filtration rate (e-GFR) \<60 mL/min/1.73m2 using the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation
   5. International normalized ratio (INR) \>1.3.
   6. Albumin \< 3.6 g/dL
9. Liver stiffness measurement (LSM) by VCTE \> 20 kPa
10. Further exclusion criteria apply

Where it's running

• University of Alabama Birmingham
  Birmingham, Alabama, United States Recruiting
• Atlantic Clinical Research Institute
  West Palm Beach, Florida, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• UT Health Houston
  Houston, Texas, United States Recruiting
• UC San Diego Altman Clinical and Translational Research Institute
  La Jolla, California, United States Not yet recruiting

Study contacts

• Study coordinator: Holly Crandall, BSN
• Email: hrking1@iu.edu
• Phone: 13172786200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.