NCT07143968

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Nov 2027

First Submitted

Initial submission to the registry

August 25, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

April 23, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

May 6, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

August 25, 2025

Last Update Submit

May 4, 2026

Conditions

HIV (Human Immunodeficiency Virus)MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in hepatic fat content at week 24

    From baseline to the end of treatment at 24 weeks

Secondary Outcomes (2)

  • 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

Study Arms (2)

Treatment

EXPERIMENTAL

Resmetirom - 80mg or 100mg based on participant weight

Drug: Resmetirom

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Control

Interventions

Placebo ControlDRUG

Placebo - an identical looking tablet with no medicinal properties

Placebo
ResmetiromDRUG

Resmetirom - 80mg or 100mg based on participant weight

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

NOT YET RECRUITING

UC San Diego Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

NOT YET RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

NOT YET RECRUITING

Atlantic Clinical Research Institute

West Palm Beach, Florida, 33409, United States

NOT YET RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21205, United States

NOT YET RECRUITING

Mt Sinai Health System

New York, New York, 10029, United States

NOT YET RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

UT Health Houston

Houston, Texas, 77030, United States

NOT YET RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

resmetirom

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Holly Crandall, BSN

CONTACT

13172786200hrking1@iu.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 25, 2025

First Posted

August 27, 2025

Study Start

April 23, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-01

Locations

US(10)