Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV

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)

A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV (NCT07143968) is a Phase 2 interventional studying MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and HIV (Human Immunodeficiency Virus), sponsored by Naga P. Chalasani. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Resmetirom

Resmetirom - 80mg or 100mg based on participant weight

DRUG

Placebo Control

Placebo - an identical looking tablet with no medicinal properties

Locations (10)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Alabama Birmingham

Birmingham, Alabama, United States

UC San Diego Altman Clinical and Translational Research Institute

La Jolla, California, United States

University of California, San Francisco

San Francisco, California, United States

Atlantic Clinical Research Institute

West Palm Beach, Florida, United States

Indiana University

Indianapolis, Indiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Mt Sinai Health System

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

UT Health Houston

Houston, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07143968), the sponsor (Naga P. Chalasani), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07143968 clinical trial studying?

Who can participate in NCT07143968?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07143968?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07143968. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07143968. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.