Semaglutide for HIV-Associated Lipohypertrophy

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether the medication semaglutide (an injectable product) can reduce certain types of body fat and improve heart health in people with HIV who have lipohypertrophy (abnormal fat accumulation). The researchers aim to determine if semaglutide can decrease visceral and ectopic fat, which are stored in the belly and around organs. Participants will receive either semaglutide or a placebo (a treatment with no active medicine) and will be monitored for changes in fat and related health markers. People with HIV who have noticed an increase in belly size after starting HIV treatment might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you need to stop taking your current medications, but you must have been on a stable antiretroviral regimen for at least 12 weeks before the study. Some medications, like metformin, NSAIDs, and statins, must be used consistently for 6 months prior to the study without changes.

Is there any evidence suggesting that semaglutide is likely to be safe for humans?

Research has shown that semaglutide is generally safe for people with HIV, with no unique side effects compared to others. In past studies, participants taking a 1.0 mg dose of semaglutide experienced no new or unexpected side effects, indicating that the side effects were similar to those in other groups taking semaglutide.

However, it is important to remember that while semaglutide appears promising, more research is needed to fully understand the risk of serious side effects. Although many people tolerate it well, scientists continue to study its safety. Prospective trial participants can use this information to understand what to expect regarding safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV-associated lipohypertrophy?

Unlike the standard treatments for HIV-associated lipohypertrophy, which often focus on lifestyle changes or surgical interventions, semaglutide offers a unique approach. Semaglutide is an injectable medication that was originally developed for diabetes and works by mimicking a hormone called GLP-1 to regulate appetite and insulin release. Researchers are excited about semaglutide because it targets the metabolic processes linked to fat distribution, potentially reducing abnormal fat deposits in people with HIV. This new mechanism of action may provide a less invasive and more effective option for managing this condition compared to current treatments.

What evidence suggests that semaglutide might be an effective treatment for HIV-associated lipohypertrophy?

Research has shown that semaglutide, which participants in this trial may receive, might help treat HIV-associated lipohypertrophy, a condition characterized by abnormal fat accumulation. Studies have found that semaglutide can cause weight loss in people with HIV, similar to its effects in the general population. Evidence also indicates that semaglutide can lower inflammation, potentially improving overall health for those with this condition. Early findings suggest that semaglutide could help manage fat buildup and possibly reduce the risk of heart disease. However, more research is needed to fully understand the risk of serious side effects. ^{1 2 3 6 7}

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.

You are willing to comply with all study procedures and are available for the duration of the study.

I have been on a consistent HIV treatment for the last year.

Exclusion Criteria

Elevated lipase level >1.5 upper limit of normal

AST AND ALT >2.5x upper limit of normal

I do not have any ongoing infections, inflammations, or untreated cancers.

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38964353/

Once-weekly semaglutide in people with HIV-associated ... Semaglutide holds promise as an effective treatment for HIV-associated lipohypertrophy. The potential risk of serious adverse events deserves further scrutiny ...

2. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(24)00162-1/fulltext

Semaglutide in people with HIV-associated lipohypertrophy In recent studies of people with HIV, semaglutide has shown a similar degree of weight loss as in the general population, ... 4. Haidar, L ∙ Crane ...

3. jwatch.org jwatch.org/na57711/2024/07/17/semaglutide-hiv-associated-lipohypertrophy

Semaglutide for HIV-Associated Lipohypertrophy These promising results suggest that semaglutide may be effective for managing HIV-associated lipohypertrophy.

4. academic.oup.com academic.oup.com/ofid/article/12/4/ofaf152/8088019

Effects of Semaglutide on Inflammation and Immune Activation ... Here, we present the preplanned outcomes of 32 weeks of semaglutide treatment on plasma markers of inflammation and on immune cell populations ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04019197

NCT04019197 | Effects of Semaglutide in HIV-Associated ... This study is a phase IIb, randomized, double-blinded, placebo-controlled clinical trial of semaglutide in people with HIV-associated lipohypertrophy.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2213858724001505/pdf

Once-weekly semaglutide in people with HIV-associated ... The effects of semaglutide showed substantial decreases in adipose tissue, particularly abdominal visceral adipose tissue, total body fat, and ectopic ...

7. medrxiv.org medrxiv.org/content/10.1101/2025.07.09.25331038v1.full-text

Semaglutide Slows Epigenetic Aging in People with HIV ... Semaglutide Slows Epigenetic Aging in People with HIV-associated lipohypertrophy: Evidence from a Randomized Controlled Trial. Michael J ...