Semaglutide for HIV-Associated Lipohypertrophy

Recruiting at 1 trial location

Overseen By Allison R Eckard, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Western Reserve University

Must be taking: Antiretrovirals

Must not be taking: Steroids, Growth hormones

Disqualifiers: Cardiovascular disease, Diabetes, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

108 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Grace McComsey, MD

Principal Investigator

Case Western Reserve University

Allison R Eckard, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Participants with HIV and lipohypertrophy: semaglutide arm Experimental Treatment 1 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 arm Placebo Group 1 Intervention

Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.

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+