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New treatment option for MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
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?
Resmetirom is an investigational medicine, being studied as a potential treatment for masld - metabolic dysfunction-associated steatotic liver disease.
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
- 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.
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- La Jolla, California, United States
- San Francisco, California, United States
- West Palm Beach, Florida, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Houston, Texas, United States
- Richmond, Virginia, 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 - 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?
Study sites include Birmingham, Alabama, United States; La Jolla, California, United States; San Francisco, California, United States; West Palm Beach, Florida, United States; Indianapolis, Indiana, United States; Baltimore, Maryland, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.