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NCT06935838 · ClinicalTrials.gov registry record · Phase 2
Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
A Phase 2 study of HIV and Obesity and Overweight, sponsored by University of Hawaii.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06935838: Recruiting Phase 2 study of HIV and Obesity and Overweight, sponsored by University of Hawaii.
NCT06935838 is a Phase 2 study of HIV and Obesity and Overweight that is actively recruiting participants, run by University of Hawaii. The registered enrollment target is 12 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06935838, a Phase 2 study of HIV and Obesity and Overweight, is actively recruiting participants, sponsored by University of Hawaii.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. The investigators will collect the following information via review of the medical record: age, race/ethnicity, sex, medical conditions, medications, most recent standard of care HIV labs (including T-cell panel and HIV-1 viral load). The primary outcome will be the change in baseline body weight at 12 weeks. Secondary outcomes will be changes in body composition, liver fat content and liver stiffness, inflammatory markers, cardiometabolic markers (lipids and HbA1c), and monocytes at 12 weeks. There will be a 4-week safety follow up off TZP.
Primary Outcome
The primary outcome will be the change in baseline body weight (measured in lbs) at 12 weeks.
Conditions Studied
Interventions
- DRUG Tirzepatide
Study Locations (1)
Hawaii
- John A Burns School of Medicine - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-11-12 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
What NCT06935838 shows while recruiting
NCT06935838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 1 intervention - of which Tirzepatide is the first listed.
NCT06935838 reports a single indexed study location in Hawaii.
Frequently Asked Questions
What is clinical trial NCT06935838 about?
NCT06935838 is a clinical study titled "Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV". This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals...
What is the current status of trial NCT06935838?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2025-11-12. Estimated completion is 2026-07-31.
What conditions does trial NCT06935838 study?
This clinical trial studies the following conditions: HIV, Obesity and Overweight, Chronic Inflammation.
What interventions are being tested in trial NCT06935838?
The interventions under investigation include: Tirzepatide (DRUG).
Who is sponsoring clinical trial NCT06935838?
This trial is sponsored by University of Hawaii, which has 77 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06935838 being conducted?
This trial has 1 study location across Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
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 NCT06935838's enrollment target sits among peer trials
12 293rd of 303 higher than 7 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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.
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