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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
Diseases
Obesity, HIV
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
John A Burns School of Medicine
Coordinator of this site? Confirm its status
HonoluluUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.