Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV (NCT06935838) | Clinical Trial Compass
CompletedPhase 2
Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
United States12 participantsStarted 2025-11-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial, which means it's still in relatively early testing — what does that mean for how much we know so far about whether tirzepatide is safe and effective specifically for people living with HIV?
2The trial is looking at weight loss and chronic inflammation together — could you explain how chronic inflammation connects to my HIV and why treating obesity might matter beyond just the number on the scale?
3Tirzepatide is already approved for weight management in the general population, but this study is specifically in people with HIV — are there any known interactions between tirzepatide and antiretroviral medications I should be aware of before considering this?
4Since the trial is actively recruiting, what would participation actually look like day-to-day — how many visits, how long is the study, and is this realistic given my current schedule and health situation?
5Before I consider a clinical trial like this, would standard obesity treatment options or any approved medications be a better first step for someone with my specific HIV and health history?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.