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NCT04019197 · ClinicalTrials.gov registry record · Phase 2

Effects of Semaglutide in HIV-Associated Lipohypertrophy

A Phase 2 study of Obesity and HIV/AIDS, sponsored by Case Western Reserve University.

Active
Registry status
Phase 2
Development phase
108
Enrollment target
2
Study locations

NCT04019197: Active Phase 2 study of Obesity and HIV/AIDS, sponsored by Case Western Reserve University.

NCT04019197 is a Phase 2 study of Obesity and HIV/AIDS that is active but no longer recruiting, run by Case Western Reserve University. The registered enrollment target is 108 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04019197, a Phase 2 study of Obesity and HIV/AIDS, is active but no longer recruiting, sponsored by Case Western Reserve University.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
108 participants
Enrollment target
2
Study locations

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.

Primary Outcome

Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of abdominal fat (total, subcutaneous, visceral) as measured in area via abdominal CT scan.

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

FieldValue
Enrollment Target 108 participants
Start Date 2019-05-16
Est. Completion 2026-02-28
Phase Phase 2
Case Western Reserve University

141 total trials

What the registry record for NCT04019197 still lists

NCT04019197 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (87% lower).

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.

NCT04019197 reports a single indexed study location in Ohio, South Carolina.

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.

What interventions are being tested in trial NCT04019197?

The interventions under investigation include: Placebo (DRUG), Semaglutide Injectable Product (DRUG).

Who is sponsoring clinical trial NCT04019197?

This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04019197's enrollment target sits among peer trials

108 461st of 1053 higher than 592 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04019197, the US trial registry maintained by the National Library of Medicine. NCT04019197 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.