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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
John A Burns School of Medicine
Honolulu, Hawaii, United States
Start Date
November 12, 2025
Primary Completion Date
July 31, 2026
Completion Date
July 31, 2026
Last Updated
November 28, 2025
12
ESTIMATED participants
Tirzepatide
DRUG
Lead Sponsor
University of Hawaii
NCT04929028
NCT07071623
Data Source & Attribution
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