Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-29 @ 11:42 AM
Study NCT ID:
NCT07143968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV
Sponsor:
Naga P. Chalasani
Organization:
Study Overview
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)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: