108 Participants Needed

Semaglutide for HIV-Associated Lipohypertrophy

Recruiting at 1 trial location
GM
AR
Overseen ByAllison R Eckard, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Case Western Reserve University
Must be taking: Antiretrovirals
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests semaglutide, a medication that controls blood sugar, in people with HIV who have abnormal fat accumulation. It aims to see if the drug can reduce fat, improve blood vessel function, and lower inflammation. Semaglutide has been used to improve blood sugar levels and reduce body weight in individuals with obesity and type 2 diabetes.

Research Team

GA

Grace McComsey, MD

Principal Investigator

Case Western Reserve University

AR

Allison R Eckard, MD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

Adults over 18 with HIV and obesity (BMI ≥25 kg/m²) who have experienced increased abdominal size after starting HIV treatment. Participants must be on stable antiretroviral therapy, with controlled HIV-1 RNA levels for at least 6 months, and not planning to change their HIV medication or start a weight loss program during the study. Women of childbearing potential must test negative for pregnancy and agree to use contraception.

Inclusion Criteria

My belly has gotten bigger since starting HIV treatment.
I have been on a consistent HIV treatment for the last year.
You are willing to comply with all study procedures and are available for the duration of the study.
See 13 more

Exclusion Criteria

I do not have any ongoing infections, inflammations, or untreated cancers.
Elevated lipase level >1.5 upper limit of normal
AST AND ALT >2.5x upper limit of normal
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide or placebo for 32 weeks, including an 8-week dose escalation phase followed by 24 weeks at full dose

32 weeks

Follow-up

Participants are monitored for sustainability of treatment effects after discontinuation

24 weeks

Treatment Details

Interventions

  • Semaglutide Injectable Product
Trial Overview The trial is testing Semaglutide, a drug that may reduce fat accumulation and improve heart health in people with HIV-associated lipohypertrophy. It's compared against a placebo in a randomized, double-blinded setup to see if it changes visceral fat, insulin resistance, inflammation markers, and cardiovascular risk.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants with HIV and lipohypertrophy: semaglutide armExperimental Treatment1 Intervention
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.
Group II: Participants with HIV and lipohypertrophy: placebo armPlacebo Group1 Intervention
Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials
314
Recruited
236,000+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+
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