Effects of Semaglutide in HIV-Associated Lipohypertrophy

NCT04019197 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing whether the medication semaglutide reduces abdominal fat in people living with HIV who have lipohypertrophy.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 108 people

Who can join Ages 18+ · all sexes Healthy volunteers accepted.

Timeline Started 2019-05 · est. completion 2026-09

Where 2 sites · United States

What this study is testing ClinicalTrials.gov NCT04019197 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide Injectable Product also known as semaglutide, Ozempic Drug

semaglutide subcutaneous injection
Placebo also known as placebo injection, placebos Drug

placebo injection

Main thing measured	Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline
Sponsor	Case Western Reserve University
Conditions studied	HIV/AIDS, Lipohypertrophy, Obesity
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04019197 ↗