This study is not yet accepting patients

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

a study on Liver Disease HIV/AIDS Immunodeficiency

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study ends around
Principal Investigator
by Rohit Loomba, MD
Headshot of Rohit Loomba
Rohit Loomba

Description

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.

Official Title

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)

Keywords

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, HIV (Human Immunodeficiency Virus), Acquired Immunodeficiency Syndrome, resmetirom

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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

Locations

  • UC San Diego Altman Clinical and Translational Research Institute
    La Jolla California 92037 United States
  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSD

  • Rohit Loomba, MD
    Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 881 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Naga P. Chalasani
ID
NCT07143968
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated