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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 weeks
Awards & highlights
Study 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 belowSelect...
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.
Select...
I have confirmed HIV-1 infection.
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I have been on a consistent HIV medication regimen for the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
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 moreOther outcome measures
Changes over time in HIV-associated lipohypertrophy
Effects of semaglutide on adipokines and natriuretic peptides
Effects of semaglutide on neurocognitive scores
+6 moreTrial 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.
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaOTHER
932 Previous Clinical Trials
7,394,152 Total Patients Enrolled
Case Western Reserve UniversityLead Sponsor
299 Previous Clinical Trials
259,912 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,314,958 Total Patients Enrolled
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medicinal purpose is Semaglutide Injectable Product typically utilized for?
"Semaglutide Injectable Product is a viable solution for enduring weight management, reduced-calorie diets, and exercise regimens."
Answered by AI
How many participants are engaging in this experiment?
"Yes, the data on clinicaltrials.gov affirms that this research study is still seeking participants. This investigation was originally listed in May of 2019 and most recently edited on July 25th 2022. In total, 104 patients are being sought after from two sites."
Answered by AI
Are there any previous studies that have featured Semaglutide Injectable Product?
"Semaglutide Injectable Product was first examined in 2018 at a Novo Nordisk Investigational Site. To date, 18434 clinical trials have concluded, with 58 active studies primarily based out of Cleveland, Ohio."
Answered by AI
Has the FDA given their stamp of approval to Semaglutide Injectable Product?
"Our team has evaluated the safety of Semaglutide Injectable Product and deemed it worthy of a score of 2, which is indicative that data exists suggesting its safety but efficacy still needs to be established."
Answered by AI
Is this investigation a pioneering effort?
"Since its initiation in 2018, sponsored by Novo Nordisk A/S, a Phase 4 drug approval trial for Semaglutide Injectable Product has been taking place across 55 countries and 772 cities. To date, 58 live studies are still active with 18434 trials having already concluded successfully."
Answered by AI
Are there presently opportunities for participation in this experiment?
"According to the clinicaltrials.gov website, this medical trial is still open for enrolment. It was first listed on May 16th 2019 and last revised on July 25th 2022."
Answered by AI
What is the purpose of this experimental research?
"The 56-week trial aims to assess the impact of semaglutide on visceral abdominal fat. Secondary objectives include measuring changes in liver fat, gut hormones (GIP and GLP-1 levels) via mixed meal test tolerance, and pulse wave velocity as a surrogate measure for cardiovascular disease risk."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
How old are they?
65+
What site did they apply to?
Case Western Reserve University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I try a couple diet in the past and hope this study would help me.
PatientReceived 1 prior treatment
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