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Can a liver drug help people with HIV? new trial aims to find out

NCT ID NCT07143968

Disease control Sponsor: Naga P. Chalasani Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests whether resmetirom, a drug already approved for another liver condition, can safely reduce liver fat in people with HIV who also have fatty liver disease (MASLD). About 120 adults with well-controlled HIV will take either resmetirom or a placebo daily for 24 weeks. Researchers will measure changes in liver fat using MRI scans and track safety through blood tests and clinic visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
resmetirom
What this could lead to
If it works, this could point toward a treatment for fatty liver disease in people with HIV, a group often excluded from earlier studies.
What could go wrong
This is a small, early-phase trial (120 people) with a short 24-week treatment period. The drug may not reduce liver fat significantly, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV (human immunodeficiency virus) Masld (metabolic dysfunction-associated steatotic liver disease)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlantic Clinical Research Institute

    RECRUITING

    West Palm Beach, Florida, 33409, United States

  • Duke University Medical Center

    NOT_YET_RECRUITING

    Durham, North Carolina, 27710, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Mt Sinai Health System

    NOT_YET_RECRUITING

    New York, New York, 10029, United States

  • UC San Diego Altman Clinical and Translational Research Institute

    NOT_YET_RECRUITING

    La Jolla, California, 92037, United States

  • UT Health Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Alabama Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of California, San Francisco

    NOT_YET_RECRUITING

    San Francisco, California, 94143, United States

  • Virginia Commonwealth University

    NOT_YET_RECRUITING

    Richmond, Virginia, 23298, United States

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