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

Last updated: November 25, 2025
Sponsor: University of Hawaii
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Inflammation

Treatment

Tirzepatide

Clinical Study ID

NCT06935838
H064
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Tirzepatide
Phase: 2
Study Start date:
November 12, 2025
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • John A Burns School of Medicine

    Honolulu 5856195, Hawaii 5855797 96813
    United States

    Active - Recruiting

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