Purpose of this Study
This study lasts about 28 weeks. The first 12 weeks are used to check if a person can join. Then there are 24 weeks of treatment and 4 weeks of follow up. People are put into groups by chance. Some will get the study medicine called resmetirom and some will get a pill that has no medicine in it. No one will know which pill they receive. During the study, people will have regular visits for blood tests, liver scans, check ups, and safety checks to watch for any side effects.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older. They must have HIV that is controlled with medicine and have fatty liver disease shown on a scan. They cannot join if they have serious liver damage or other major liver problems. They also cannot join if they drink a lot of alcohol or have serious health issues. Women who are pregnant or breastfeeding cannot take part in the study.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a medicine to see if it can lower the amount of fat in the liver and keep the liver healthy. Some people will get the real medicine and others will get a pill with no medicine so the results can be compared. The goal is to find better treatments for people who have HIV and fatty liver disease.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full 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)
Principal Investigator
Susanna
Naggie
Protocol Number
PRO00119582
Phase
N/A
Enrollment Status
Pending Open to Enrollment