MedTrace Logo

Effects of Semaglutide in HIV-Associated Lipohypertrophy

NCT04019197 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-05-04

Study results available
· View outcomes & findings →

Summary

This is a randomized, double-blinded, placebo-controlled trial designed to assess the effect of the GLP-1 receptor agonist, semaglutide, on visceral and ectopic fat, insulin resistance, inflammation markers, and the downstream effect of cardiovascular risk in people with HIV. The primary endpoints will be visceral and ectopic fat changes over the study period. The secondary endpoints will include changes in markers of inflammation, immune activation, gut integrity, and cardiovascular disease risk assessment.

Conditions

Interventions

DRUG

Semaglutide Injectable Product

semaglutide subcutaneous injection

DRUG

Placebo

placebo injection

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Grace A McComsey, MD · Case Western Reserve University

  • Allison R Eckard, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2024-04-30
Completion
2026-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04019197 on ClinicalTrials.gov