Recruiting
Phase 2

Resmetirom

Sponsor:

Naga P. Chalasani

Code:

NCT07143968

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

HIV (Human Immunodeficiency Virus)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Resmetirom

Placebo Control

Study Details

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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

HIV (Human Immunodeficiency Virus)

Study ID

NCT07143968

Start date

Apr 23, 2026

Status verified date

Jul, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Resmetirom - 80mg or 100mg based on participant weight

placebo comparator: Placebo

Placebo

Interventions

Resmetirom

Resmetirom - 80mg or 100mg based on participant weight

Placebo Control

Placebo - an identical looking tablet with no medicinal properties

Primary outcome measure

  • Change from baseline in hepatic fat content at week 24 [ Time Frame: From baseline to the end of treatment at 24 weeks ]

Central Contacts and Locations

Central contacts

Holly Crandall, BSN

13172786200hrking1@iu.edu

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Kristen Spraggins

205-934-9346kspraggins@uabmc.edu

Principal Investigator:

Sonya Heath, MD

Atlantic Clinical Research Institute

Recruiting

West Palm Beach, Florida, United States, 33409

Contacts

Amanda Chavez

561-249-2279achavez@midwaycare.org

Principal Investigator:

Hector Bolivar, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lexi Smith

317-278-0697agoy@iu.edu

Principal Investigator:

Samer Gawrieh, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Sara Mekhael

410-550-3015sawad3@jhu.edu

Principal Investigator:

Mark Sulkowski, MD

UT Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Sarah Galloway

713-500-4363sarah.galloway@uth.tmc.edu

Principal Investigator:

Jordan Lake, MD

More Information

Sponsor

Naga P. Chalasani

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Naga P. Chalasani on 2026-07-30.