Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV Infections
- Non Alcoholic Fatty Liver Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study will evaluate the effects of semaglutide on intra-hepatic triglyceride (IHTG) content in people living with HIV (PLWH), central adiposity, insulin resistance or pre-diabetes, and hepatic steatosis. All participants will receive semaglutide subcutaneously once weekly for 24 weeks, followed...
This study will evaluate the effects of semaglutide on intra-hepatic triglyceride (IHTG) content in people living with HIV (PLWH), central adiposity, insulin resistance or pre-diabetes, and hepatic steatosis. All participants will receive semaglutide subcutaneously once weekly for 24 weeks, followed by 24 weeks of observation off of the study drug. IHTG will be quantified by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) evaluations at two time points during the study. Participants will attend several study visits through Week 48. Participants will complete food diaries, adherence and strength assessments, and report on hypoglycemia, vision changes, physical activity, diet, quality of life, and acceptability of study drug. Blood will be collected at all visits and stool samples at two visits. Participants must remain on their non-study-provided antiretroviral therapy (ART) throughout the study.
Tracking Information
- NCT #
- NCT04216589
- Collaborators
- The University of Texas Health Science Center, Houston
- Investigators
- Study Chair: Kristine Erlandson, MD, MS University of Colorado Hospital CRS Study Chair: Jordan E. Lake, MD, MSc Houston AIDS Research Team CRS