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GLP-1 Receptor Agonist

Semaglutide for HIV-Associated Lipohypertrophy

Phase 2
Waitlist Available
Led By Allison R Eckard, MD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving a stable antiretroviral regimen for at least the last 12 weeks prior to study entry with cumulative duration of 1 year of treatment at the time of study entry.
Waist circumference and waist-to-hip ratio >95 cm and >0.94 cm, respectively, for men, and >94 cm and >0.88 cm, respectively, for women occurring in the context of HIV treatment.
Must not have
Any active or chronic uncontrolled inflammatory condition, infection or cancer
Glomerular filtration rate <50 cc/min/1.73 m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 weeks
Awards & highlights

Summary

This trial will assess the effect of semaglutide on visceral and ectopic fat in people with HIV, as well as changes in markers of inflammation, immune activation, gut integrity, and cardiovascular disease risk assessment.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Semaglutide can cause digestive issues like nausea or diarrhea, increase the risk of low blood sugar levels especially when combined with other diabetes medications, possible thyroid tumors including cancer (rare), pancreatitis (inflammation of the pancreas), gallbladder problems like gallstones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a consistent HIV treatment for the last year.
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My waist size and ratio are high due to HIV treatment.
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I have confirmed HIV-1 infection.
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I have been on a consistent HIV medication regimen for the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any ongoing infections, inflammations, or untreated cancers.
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My kidney function is reduced.
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I have had moderate to severe stomach issues in the past month.
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I am not pregnant or breastfeeding.
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I have a history of heavy drinking, pancreatitis, thyroid cancer, or MEN syndrome type 2.
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I have used growth hormone treatments in the past year or plan to start.
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I am not pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effects of semaglutide on quantity of abdominal fat (total, subcutaneous, visceral)
Effects of semaglutide on quantity of fat (total body fat, limb fat, trunk fat)
Effects of semaglutide on quantity of pericardial fat
Secondary outcome measures
Effects of semaglutide on EndoPat
Effects of semaglutide on anthropometric measurements (weight, waist circumference, waist-to-hip ratio)
Effects of semaglutide on bone
+45 more
Other outcome measures
Changes over time in HIV-associated lipohypertrophy
Effects of semaglutide on adipokines and natriuretic peptides
Effects of semaglutide on neurocognitive scores
+6 more

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
GLP-1 receptor agonists, such as semaglutide, work by mimicking the incretin hormone GLP-1, which enhances glucose-dependent insulin secretion, inhibits glucagon release, and slows gastric emptying. These actions collectively improve insulin sensitivity and reduce visceral fat accumulation, which is crucial for patients with lipohypertrophy. By targeting visceral fat, these treatments help mitigate the metabolic complications associated with lipohypertrophy, such as insulin resistance and increased cardiovascular risk.
Wegovy (semaglutide): a new weight loss drug for chronic weight management.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaOTHER
947 Previous Clinical Trials
7,397,960 Total Patients Enrolled
Case Western Reserve UniversityLead Sponsor
300 Previous Clinical Trials
246,503 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,314,994 Total Patients Enrolled

Media Library

Semaglutide Injectable Product (GLP-1 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04019197 — Phase 2
Lipohypertrophy Research Study Groups: Participants with HIV and lipohypertrophy: placebo arm, Participants with HIV and lipohypertrophy: semaglutide arm
Lipohypertrophy Clinical Trial 2023: Semaglutide Injectable Product Highlights & Side Effects. Trial Name: NCT04019197 — Phase 2
Semaglutide Injectable Product (GLP-1 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04019197 — Phase 2
Lipohypertrophy Patient Testimony for trial: Trial Name: NCT04019197 — Phase 2
~18 spots leftby Jul 2025