Effects of Semaglutide in HIV-Associated Lipohypertrophy (NCT04019197) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Effects of Semaglutide in HIV-Associated Lipohypertrophy
United States108 participantsStarted 2019-05-16
Plain-language summary
This is a randomized, double-blinded, placebo-controlled trial designed to assess the effect of the GLP-1 receptor agonist, semaglutide, on visceral and ectopic fat, insulin resistance, inflammation markers, and the downstream effect of cardiovascular risk in people with HIV. The primary endpoints will be visceral and ectopic fat changes over the study period. The secondary endpoints will include changes in markers of inflammation, immune activation, gut integrity, and cardiovascular disease risk assessment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, aged ≥18 years.
. HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
. Body mass index ≥25 kg/m2.
. 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.
. Subjective evidence of increased abdominal girth occurring after initiation of HIV treatment.
. HIV-1 RNA \<400 copies/mL for ≥6 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effects of Semaglutide on Quantity of Abdominal Fat (Total, Subcutaneous, Visceral) at Week 32 Compared to Baseline
Timeframe: 32 weeks
2
Effects of Semaglutide on Quantity of Fat (Total Body Fat, Limb Fat, Trunk Fat) at Week 32 Compared to Baseline
Timeframe: 32 weeks
3
Effects of Semaglutide on Quantity of Ectopic Fat (Total Pericardial Fat) at Week 32 Compared to Baseline
. 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.
. Provision of signed and dated informed consent form and is capable of reading and comprehending the informed consent.
Exclusion criteria
. Known cardiovascular disease or diagnosed diabetes. If on metformin without a diabetes diagnoses metformin use has to be constant, uninterrupted for 6 months prior to entry.
. Any active or chronic uncontrolled inflammatory condition, infection or cancer.
. Women who are pregnant or breastfeeding.
. Women with a positive pregnancy test on enrollment or prior to study drug administration.
. A clinically-relevant illness within 14 days prior to study entry not explicitly excluded by the protocol, a physical or psychiatric disability, or a laboratory abnormality that might place the subject at increased risk by being exposed to the medications in this study or which might confound the interpretation of this investigation.
. Active gastrointestinal symptom Grade \>1 within the last month.
. Regular use of immunomodulators/agents which could impact inflammation. Regular use of NSAIDS allowed if constant, uninterrupted for 6 months and no plans to alter. Statin use must also be constant, uninterrupted for 6 months prior to study entry. Thyroid medication allowed unless diagnosed with uncontrolled thyroid disease.
. Inability to communicate effectively with study personnel.