Trials / Not Yet Recruiting
Not Yet RecruitingNCT07143968
A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
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)
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Naga P. Chalasani · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Resmetirom | Resmetirom - 80mg or 100mg based on participant weight |
| DRUG | Placebo Control | Placebo - an identical looking tablet with no medicinal properties |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2027-09-01
- Completion
- 2027-10-01
- First posted
- 2025-08-27
- Last updated
- 2026-02-03
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07143968. Inclusion in this directory is not an endorsement.