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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Resmetirom — DRUG
  Resmetirom - 80mg or 100mg based on participant weight
• Placebo Control — DRUG
  Placebo - an identical looking tablet with no medicinal properties

Study Details

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.

Key Dates

Start date

Apr 23, 2026

Status verified

Jan 2026

Primary completion

Oct 31, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  Resmetirom - 80mg or 100mg based on participant weight
• Placebo Comparator: Placebo
  Placebo

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

• Holly Crandall, BSN
  13172786200
  [email protected]

Locations (10)

Find similar trials in Birmingham, AL

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