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
    Not Recruiting
  • End date
    Dec 15, 2023
  • participants needed
    50
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 20 October 2022
diabetes
insulin
vasectomy
metabolic syndrome
corticosteroids
hysterectomy
antiretroviral
fasting
antiretroviral agents
antiretroviral therapy
hiv test
hepatitis
insulin resistance
vitamin e
liver disease
neutrophil count
fatty liver
hemoglobin a1c
glycosylated hemoglobin
HIV Vaccine
steatosis
investigational new drug
vitamins
immune globulin
liver function tests
antibody test
hiv-1 infection
semaglutide
fibrates
mri-pdff
hiv-1 rna measurement
hiv-1 antigen

Summary

The purpose of this study is 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.

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 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.

Details
Condition HIV Infections, Non-Alcoholic Fatty Liver Disease
Treatment semaglutide
Clinical Study IdentifierNCT04216589
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on20 October 2022

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