MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseasePhase 2NCT07143968
A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
A Phase 2 study testing Resmetirom in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and HIV (Human Immunodeficiency Virus), run by Naga P. Chalasani at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, HIV (Human Immunodeficiency Virus)
- What is being tested?
- Resmetirom
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 10 sitesUnited States
- Study dates
- 23 Apr 2026to Nov 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
- Further exclusion criteria apply
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Sara Mekhael, 410-550-3015, sawad3@jhu.edu
Mark Sulkowski, MD
- Recruiting
University of Alabama Birmingham
Birmingham, Alabama, 35294
Kristen Spraggins, 205-934-9346, kspraggins@uabmc.edu
Sonya Heath, MD
- Not yet recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Rebecca Mangus, 919-668-3199, rebecca.mangus@duke.edu
Susanna Naggie, MD
- Recruiting
UT Health Houston
Houston, Texas, 77030
Sarah Galloway, 713-500-4363, sarah.galloway@uth.tmc.edu
Jordan Lake, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Lexi Smith, 317-278-0697, agoy@iu.edu
Samer Gawrieh, MD
- Not yet recruiting
UC San Diego Altman Clinical and Translational Research Institute
La Jolla, California, 92037
Egbert Mandamba, 858-246-2227, emandamba@health.ucsd.edu
Rohit Loomba, MD
- Not yet recruiting
Mt Sinai Health System
New York, New York, 10029
Mark Miller, 212-824-7672, mark.miller@mssm.edu
Meena Bansal, MD
- Not yet recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Dianne Boyce Grogan, 804-828-2988, dianne.boycegrogan@vcuhealth.org
Richard Sterling, MD
- Not yet recruiting
University of California, San Francisco
San Francisco, California, 94143
Rosaura Camberos, 415-619-9919, rosaura.camberos@ucsf.com
Jennifer Price, MD
- Recruiting
Atlantic Clinical Research Institute
West Palm Beach, Florida, 33409
Amanda Chavez, 561-249-2279, achavez@midwaycare.org
Hector Bolivar, MD
About this study
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)
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.
Read more
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)
- Being tested
- Resmetirom, Placebo Control
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResmetiromDrug
Resmetirom - 80mg or 100mg based on participant weight
Placebo ControlDrug
Placebo - an identical looking tablet with no medicinal properties
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Resmetirom - 80mg or 100mg based on participant weight Receives: Drug: Resmetirom |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hepatic fat content at week 24
Measured: 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
Measured: Baseline to the end of treatment at week 24
Change from baseline in liver enzyme parameters, lipid profile and fasting glucose
Measured: From baseline to end of treatment at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start23 Apr 2026
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naga P. Chalasani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naga P. Chalasani, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143968
- Sponsor's protocol ID
- HCRN005
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Await IRB determination of privacy and HIPAA issues