MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease study: Resmetirom
Official title A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
ClinicalTrials.gov ID: NCT07143968
What this study is testing
What is Resmetirom?
This is an investigational daily pill being studied to see if it can reduce liver fat in people with HIV and MASLD. It is designed to activate a specific sensor in the body that helps regulate how the liver handles fats and sugars.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if the drug resmetirom is safe and helps lower the amount of fat in the liver for people with HIV.
- Who it's for
- Adults over 18 who have HIV, are taking daily HIV medication, and have been diagnosed with fatty liver disease.
- What's involved
- Participants take a daily pill (either the study drug or a sugar pill) for 24 weeks. They will have two MRI scans to measure liver fat and attend clinic visits for blood tests.
- Time commitment
- The study lasts about 24 weeks of treatment plus follow-up calls, requiring three initial screening visits and three clinic visits during treatment.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1...
- 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
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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
- Uncontrolled T2DM defined as glycated hemoglobin (HbA1c) \>9.5% 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- West Palm Beach, Florida, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; West Palm Beach, Florida, United States; Indianapolis, Indiana, United States; Baltimore, Maryland, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.