Effects of Semaglutide in HIV-Associated Lipohypertrophy

Conditions

• HIV/AIDS
• Lipohypertrophy
• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Semaglutide Injectable Product — DRUG
  semaglutide subcutaneous injection
• Placebo — DRUG
  placebo injection

Study Details

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.

Key Dates

Start date

May 16, 2019

Status verified

Apr 2026

Primary completion

Apr 30, 2024

Completion

Sep 1, 2026

Study Design

Enrollment

108 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Participants with HIV and lipohypertrophy: semaglutide arm
  Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.
• Placebo Comparator: Participants with HIV and lipohypertrophy: placebo arm
  Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.

Primary Outcome Measure

Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline [ Time Frame: 32 weeks ]

Locations (2)

Related coverage on Hipa.ai

• Semaglutide Reduces Abdominal and Total Body Fat in HIV Lipohypertrophy
  Semaglutide · Feb 17, 2026 · ClinicalTrials.gov

Find similar trials in Cleveland, OH

Related Studies

• RESET System Pivotal Trial (Rev F)
  Recruiting · Morphic Medical Inc. · Washington D.C., District of Columbia
• Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
  PHASE2 · Recruiting · Etan Orgel · Los Angeles, California
• Inspiratory Muscle Training in Obese Breast Cancer Survivors
  Recruiting · Ohio State University Comprehensive Cancer Center · Columbus, Ohio
• EMPOWER: Effects of Weight Loss and Exercise Post-stroke
  Recruiting · Medical University of South Carolina · Charleston, South Carolina