Recruitment

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