NCT06935838CompletedPhase 2
Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 4 Apr 2025
- Start date
- 12 Nov 2025
- Primary completion date
- 2 Jun 2026
- Lead sponsor
- University of Hawaii
- NCT number
- NCT06935838
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 12
- From 12 Nov 2025 to the primary completion date, 2 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Age ≥ 18 years
- HIV-1 infection (well controlled)
- Documented HIV-1 infection ≥ 1 year prior to study entry (ELISA confirmed by Western blot or HIV-1 RNA) AND
- HIV-1 RNA \<200 copies/mL for ≥ 6 months
- Stable ART
- Receiving a stable antiretroviral regimen for at least 1 year prior to study entry
- Overweight
- BMI ≥27 kg/m2 plus at least one weight-related condition (defined as a medical history of dyslipidemia, hypertension, cardiovascular disease, or obstructive sleep apnea) OR Obese
- BMI ≥ 30 kg/m2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| John A Burns School of Medicine Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.