Clinical Trial

Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV

Completed Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial completed 2026-07-09
notable Primary completion moved earlier: 2026-07-31 -> 2026-06-02 2026-07-09
minor Completion moved earlier: 2026-07-31 -> 2026-06-02 2026-07-09
Trial Details
NCT Number NCT06935838
Lead Sponsor University of Hawaii
Conditions Obesity and Overweight, HIV, Chronic Inflammation
Enrollment 12 participants
Start Date 2025-11-12
Primary Completion 2026-06-02 (estimated)
Study Completion 2026-06-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-08