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Effects of Semaglutide in HIV-Associated Lipohypertrophy

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Feb 28, 2026 to Sep 1, 2026v15
  2. Re-verified, no change to tracked fieldsv14
  3. Results first posted: Feb 17, 2026
    • Study completion date: Jan 15, 2026 to Feb 28, 2026
    v13
  4. Study completion date: Dec 31, 2025 to Jan 15, 2026
    • Secondary endpoints: 45 to 46
    v12
  5. Primary endpoints revised (3)
    • Secondary endpoints: 37 to 45
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary endpoints revised (3)
    • Secondary endpoints: 48 to 37
    v10
  2. Primary completion date: Sep 30, 2023 to Apr 30, 2024
    • Study completion date: Mar 31, 2025 to Dec 31, 2025
    • Secondary endpoints revised (48)
    • Primary endpoints revised (3)
    v9
  3. Primary endpoints revised (3)
    • Study completion date: Mar 31, 2024 to Mar 31, 2025
    • Secondary endpoints: 29 to 48
    v8
  4. Primary endpoints: 4 to 3
    • Enrollment target: estimated 104 to confirmed 108
    • Secondary endpoints: 9 to 29
    • Study description shortened, about 4 words
    v7
  5. Primary completion date changed from estimate of Oct 31, 2023 to Sep 30, 2023v6
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v5
  7. 2 versions Re-verified since Mar 18, 2021, no change to tracked fieldsv3-v4
  8. Enrollment target: 208 to 104v2 Show 5 more changesShow less
    • Eligibility criteria shortened, about 436 words
    • Secondary endpoints: details revised at 8 of 9 entries
    • Study description shortened, about 53 words
    • Site contacts updated at 1 of 2 sites
    • Study arms: 4 to 2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04019197
Lead Sponsor Case Western Reserve University
Collaborators: Medical University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 HIV/AIDS, Lipohypertrophy, Obesity
Related terms Acquired Immunodeficiency Syndrome, Obesity
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov