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Clinical Trial NCT07143968 for MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, HIV (Human Immunodeficiency Virus) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV Phase 2 120

Not yet recruiting
Clinical Trial NCT07143968 is designed to study Treatment for MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, HIV (Human Immunodeficiency Virus). This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 March 2026 until the study accrues 120 participants. Led by Naga P. Chalasani, this study is expected to complete by 1 October 2027. The latest data from ClinicalTrials.gov was last updated on 3 February 2026.
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 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 wil...

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Official Title

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)

Conditions
MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseHIV (Human Immunodeficiency Virus)
Other Study IDs
  • HCRN005
NCT ID Number
NCT07143968
Start Date (Actual)
2026-03
Last Update Posted
2026-02-03
Completion Date (Estimated)
2027-10
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTreatment
Resmetirom - 80mg or 100mg based on participant weight
Resmetirom
Resmetirom - 80mg or 100mg based on participant weight
Placebo ComparatorPlacebo
Placebo
Placebo Control
Placebo - an identical looking tablet with no medicinal properties
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change from baseline in hepatic fat content at week 24
From baseline to the end of treatment at 24 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Proportion of participants with reduction of at least 30% in hepatic fat content from baseline to week 24
Baseline to the end of treatment at week 24
Change from baseline in liver enzyme parameters, lipid profile and fasting glucose
From baseline to end of treatment at week 24
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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

Naga P. Chalasani logoNaga P. Chalasani
Study Responsible Party
Naga P. Chalasani, Sponsor-Investigator, Professor of Medicine, Indiana University
Study Central Contact
Contact: Holly Crandall, BSN, 13172786200, [email protected]
9 Study Locations in 1 Countries

Alabama

University of Alabama Birmingham, Birmingham, Alabama, 35294, United States
Kristen Spraggins, Contact, 1-205-934-9346, [email protected]
Sonya Heath, MD, Principal Investigator

California

UC San Diego Altman Clinical and Translational Research Institute, La Jolla, California, 92037, United States
Egbert Mandamba, Contact, 1-858-246-2227, [email protected]
Rohit Loomba, MD, Principal Investigator
University of California, San Francisco, San Francisco, California, 94143, United States
Rosaura Camberos, Contact, 1-415-619-9919, [email protected]
Jennifer Price, MD, Principal Investigator

Florida

Atlantic Clinical Research Institute, West Palm Beach, Florida, 33409, United States
Amanda Chavez, Contact, 1-561-249-2279, [email protected]
Hector Bolivar, MD, Principal Investigator

Maryland

Johns Hopkins University, Baltimore, Maryland, 21205, United States
Sara Mekhael, Contact, 1-410-550-3015, [email protected]
Mark Sulkowski, MD, Principal Investigator

New York

Mt Sinai Health System, New York, New York, 10029, United States
Mark Miller, Contact, 1-212-824-7672, [email protected]
Meena Bansal, MD, Principal Investigator

North Carolina

Duke University Medical Center, Durham, North Carolina, 27710, United States
Rebecca Mangus, Contact, 1-919-668-3199, [email protected]
Susanna Naggie, MD, Principal Investigator

Texas

UT Health Houston, Houston, Texas, 77030, United States
Sarah Galloway, Contact, 1-713-500-4363, [email protected]
Jordan Lake, MD, Principal Investigator

Virginia

Virginia Commonwealth University, Richmond, Virginia, 23298, United States
Dianne Boyce Grogan, Contact, 1-804-828-2988, [email protected]
Richard Sterling, MD, Principal Investigator