NCT07143968 A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
| NCT ID | NCT07143968 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Naga P. Chalasani |
| Condition | MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-04-23 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2026-04-23 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07143968 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07143968 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07143968 currently recruiting?
Yes, NCT07143968 is actively recruiting participants. Contact the research team at hrking1@iu.edu for enrollment information.
Where is the NCT07143968 trial being conducted?
This trial is being conducted at Birmingham, United States, La Jolla, United States, San Francisco, United States, West Palm Beach, United States and 6 additional locations.
Who is sponsoring the NCT07143968 clinical trial?
NCT07143968 is sponsored by Naga P. Chalasani. The trial plans to enroll 120 participants.