Your session is about to expire
← Back to Search
GLP-1 Receptor Agonist
Semaglutide for HIV-Associated Lipohypertrophy
Phase 2
Waitlist Available
Led By Grace A McComsey, 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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
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 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.
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.
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 belowSelect...
I have been on a consistent HIV treatment for the last year.
Select...
My waist size and ratio are high due to HIV treatment.
Select...
I have confirmed HIV-1 infection.
Select...
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:Select...
I do not have any ongoing infections, inflammations, or untreated cancers.
Select...
My kidney function is reduced.
Select...
I have had moderate to severe stomach issues in the past month.
Select...
I am not pregnant or breastfeeding.
Select...
I have a history of heavy drinking, pancreatitis, thyroid cancer, or MEN syndrome type 2.
Select...
I have used growth hormone treatments in the past year or plan to start.
Select...
I am not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Effects of semaglutide on EndoPat
Effects of semaglutide on anthropometric measurements (weight, waist circumference, waist-to-hip ratio)
Effects of semaglutide on bone
+45 moreOther study objectives
Changes over time in HIV-associated lipohypertrophy
Effects of semaglutide on adipokines and natriuretic peptides
Effects of semaglutide on neurocognitive scores
+6 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
FDA approved
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.
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
979 Previous Clinical Trials
7,400,886 Total Patients Enrolled
Case Western Reserve UniversityLead Sponsor
309 Previous Clinical Trials
251,151 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,345 Total Patients Enrolled
Grace A McComsey, MDPrincipal InvestigatorCase Western Reserve University
2 Previous Clinical Trials
310 Total Patients Enrolled
Allison R Eckard, MDPrincipal InvestigatorMedical University of South Carolina
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any ongoing infections, inflammations, or untreated cancers.My kidney function is reduced.My belly has gotten bigger since starting HIV treatment.I have had moderate to severe stomach issues in the past month.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.I am not pregnant or breastfeeding.I am 18 years old or older.I am a woman who cannot get pregnant or my male partner cannot father a child.I have signed and understand the consent form.I use certain medications regularly without changes, including NSAIDs or statins, and my thyroid condition is under control.I have confirmed HIV-1 infection.I am not trying to conceive and will use multiple forms of birth control if sexually active.I have been on a consistent HIV medication regimen for the last year.My waist size and ratio are high due to HIV treatment.You have a higher than normal body weight for your height.I haven't used steroids or hormone therapies like megestrol or testosterone in the last 6 months.I have a history of heavy drinking, pancreatitis, thyroid cancer, or MEN syndrome type 2.I am 18 years old or older.I have used growth hormone treatments in the past year or plan to start.I won't change my HIV treatment, start a weight loss or exercise program, or have surgery during the study.I have heart disease or diabetes, or I've been taking metformin steadily for 6 months without a diabetes diagnosis.I am not pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with HIV and lipohypertrophy: placebo arm
- Group 2: Participants with HIV and lipohypertrophy: semaglutide arm
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Lipohypertrophy Patient Testimony for trial: Trial Name: NCT04019197 — Phase 2