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Effects of Semaglutide in HIV-Associated Lipohypertrophy
NCT04019197 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Semaglutide Injectable Product
Study Locations (2)
Ohio
- Case Western Reserve University — Cleveland
South Carolina
- Medical University of South Carolina — Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04019197
The ClinicalTrials.gov registry entry for NCT04019197 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Western Reserve University, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04019197 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Ohio, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04019197 about?
NCT04019197 is a clinical study titled "Effects of Semaglutide in HIV-Associated Lipohypertrophy". 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 w...
What is the current status of trial NCT04019197?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2019-05-16. Estimated completion is 2026-02-28.
What conditions does trial NCT04019197 study?
This clinical trial studies the following conditions: Obesity, HIV/AIDS, Lipohypertrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04019197?
The interventions under investigation include: Placebo (DRUG), Semaglutide Injectable Product (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04019197?
This trial is sponsored by Case Western Reserve University, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04019197 being conducted?
This trial has 2 study locations across Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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