RecruitingPhase 2NCT06935838

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

Sponsor

University of Hawaii

Enrollment

12 participants

Start Date

Nov 12, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity and Overweight HIV Chronic Inflammation

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether tirzepatide — a medication approved for weight loss and type 2 diabetes — also reduces chronic inflammation in the body. Inflammation is linked to many serious diseases, and this research could reveal additional benefits of the drug beyond blood sugar control and weight management. **You may be eligible if...** - You are an adult who is overweight or obese, or who has type 2 diabetes - You are being considered for or already using tirzepatide under a doctor's care - You are willing to provide blood samples for inflammation markers **You may NOT be eligible if...** - You have a personal or family history of thyroid cancer (medullary type) or multiple endocrine neoplasia - You have severe gastrointestinal disease - You are pregnant or breastfeeding - You have significant kidney or heart failure - You have active serious infections or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

Tirzepatide is approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, obesity and overweight with at least one weight-related medical condition, and moderate to severe obstructive sleep apnea. An initial dose of 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.