NCT04216589

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)

A Single-Arm, Open-Label, Pilot 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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to 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.

Detailed description

This study evaluated 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 received semaglutide subcutaneously once weekly for 24 weeks, followed by 24 weeks of observation off of the study drug. IHTG was quantified by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) evaluations at two time points during the study. Participants attended several study visits through Week 48. Participants completed food diaries, adherence and strength assessments, and report on hypoglycemia, vision changes, physical activity, diet, quality of life, and acceptability of study drug. Blood was collected at all visits and stool samples at two visits. Participants remained on their non-study-provided antiretroviral therapy (ART) throughout the study.

Conditions

• HIV Infections
• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Semaglutide	Administered subcutaneously

Timeline

• Start date: 2021-02-19
• Primary completion: 2023-03-16
• Completion: 2023-09-15
• First posted: 2020-01-02
• Last updated: 2024-10-01
• Results posted: 2024-05-17

Locations

9 sites across 2 countries: United States, Brazil

Regulatory

• FDA-regulated drug study