Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06935838

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

Led by University of Hawaii · Updated on 2025-11-28

12

Participants Needed

1

Research Sites

37 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Documented HIV-1 infection diagnosed at least 1 year prior to study entry
  • HIV-1 RNA viral load less than 200 copies/mL for at least 6 months
  • Receiving a stable antiretroviral therapy regimen for at least 1 year prior to study entry
  • Overweight (BMI 27 kg/m2 or higher) with at least one weight-related condition such as dyslipidemia, hypertension, cardiovascular disease, or obstructive sleep apnea, or obese (BMI 30 kg/m2 or higher)
Not Eligible

You will not qualify if you...

  • Not explicitly provided in the source

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

John A Burns School of Medicine

Honolulu, Hawaii, United States, 96813

Actively Recruiting

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Research Team

H

HICFA Clinical Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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