Tirzepatide for weight loss and chronic inflammation in people with HIV
Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
This study will try once-weekly tirzepatide injections to help adults with well-controlled HIV who are overweight or obese lose weight and reduce chronic inflammation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Hawaii Academic / other |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT06935838 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label cohort of 12 adults with well-controlled HIV on stable antiretroviral therapy who are overweight or obese. Participants will start tirzepatide 2.5 mg subcutaneously once weekly with dose escalation by 2.5 mg every 4 weeks to a target of 7.5 mg. Investigators will collect baseline clinical and HIV labs from the medical record and measure weight change at 12 weeks as the primary outcome. Secondary measures include changes in body composition, liver fat and stiffness, inflammatory and cardiometabolic markers, and monocyte measures, with a 4-week safety follow-up off tirzepatide.
Who should consider this trial
Good fit: Adults (≥18 years) with documented HIV-1 for ≥1 year, HIV-1 RNA <200 copies/mL for ≥6 months, on a stable antiretroviral regimen for ≥1 year, and with BMI ≥27 kg/m2 plus a weight-related condition or BMI ≥30 kg/m2.
Not a fit: Patients with uncontrolled HIV, those not on a stable ART regimen, or people with BMI below the study thresholds are not eligible and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, tirzepatide could produce meaningful weight loss and lower chronic inflammation, potentially improving metabolic health and liver-related measures in people with HIV.
How similar studies have performed: Tirzepatide and related GLP-1/GIP agents have produced substantial weight loss in general populations, but their effects specifically in people with HIV are only beginning to be studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Honolulu, Hawaii
- John A Burns School of Medicine — Honolulu, Hawaii, United States (Recruiting)
Study contacts
- Study coordinator: HICFA Clinical Coordinator
- Email: tzpstudy@hawaii.edu
- Phone: 808-726-0622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.