Status:
NOT_YET_RECRUITING
A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
Lead Sponsor:
Naga P. Chalasani
Conditions:
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
HIV (Human Immunodeficiency Virus)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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.
- Willingness to participate in the study.
Exclusion
- 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.
- Estimated glomerular filtration rate (e-GFR) \<60 mL/min/1.73m2 using the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation
- International normalized ratio (INR) \>1.3.
- Albumin \< 3.6 g/dL
- Liver stiffness measurement (LSM) by VCTE \> 20 kPa
- Further exclusion criteria apply
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07143968
Start Date
January 1 2026
End Date
January 1 2028
Last Update
August 27 2025
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