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

May 22, 2026 updated by: Christine Akamine, University of Hawaii
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • John A Burns School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide
Drug: Tirzepatide
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline Body Weight
Time Frame: 12 weeks
The primary outcome will be the change in baseline body weight (measured in lbs) at 12 weeks.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiometabolic markers
Time Frame: 12 weeks
We will evaluate HbA1c and a lipid profile at the baseline, week 12 and week 16 study visits.
12 weeks
Monocyte Subset Analysis
Time Frame: Week 12 and week 16
Monocyte subsets will be phenotyped from thawed/washed banked cryopreserved PBMCs (from blood drawn at baseline, week 12, and week 16) using a multiparametric panel of conjugated monoclonal antibodies: CD3, CD14, CD16, CD56, CD19, CD20, HLA-DR antibodies with Live/Dead fixable yellow dead cell stain (YARD). Data will be acquired on a 4-laser BD LSRFortessa Flow Cytometer with all compensation and gating analyses performed with the FlowJo analytical software to determine levels of classical (CD14 ++ CD16 -), intermediate (CD14 ++ CD16 +), non-classical (CD14 + CD16 ++), and transitional (CD14 + CD16 -) monocytes.
Week 12 and week 16
Change in Inflammatory Markers: GM-CSF
Time Frame: 12 weeks
All biomarkers will be assayed from banked plasma using a Luminex multiplex assay and ELISAs performed per manufacturer's instructions. A Cytokine 10-Plex Human Panel (ThermoFisher Scientific) with data acquired using Luminex 200TM system (Luminex) and ELISAs (ThermoFisher Scientific) with data acquired using a Victor X3 plate reader (PerkinElmer) will be utilized to measure the following inflammatory biomarkers: GM-CSF. Cytokine standards supplied by the manufacturer will be run in duplicate on each plate.
12 weeks
Change in Inflammatory Markers: IFN-γ
Time Frame: 12 weeks
All biomarkers will be assayed from banked plasma using a Luminex multiplex assay and ELISAs performed per manufacturer's instructions. A Cytokine 10-Plex Human Panel (ThermoFisher Scientific) with data acquired using Luminex 200TM system (Luminex) and ELISAs (ThermoFisher Scientific) with data acquired using a Victor X3 plate reader (PerkinElmer) will be utilized to measure the following inflammatory biomarkers: IFN-γ. Cytokine standards supplied by the manufacturer will be run in duplicate on each plate.
12 weeks
Change in Inflammatory Markers: IL-1β
Time Frame: 12 weeks
All biomarkers will be assayed from banked plasma using a Luminex multiplex assay and ELISAs performed per manufacturer's instructions. A Cytokine 10-Plex Human Panel (ThermoFisher Scientific) with data acquired using Luminex 200TM system (Luminex) and ELISAs (ThermoFisher Scientific) with data acquired using a Victor X3 plate reader (PerkinElmer) will be utilized to measure the following inflammatory biomarkers: IL-1β. Cytokine standards supplied by the manufacturer will be run in duplicate on each plate.
12 weeks
Change in Inflammatory Markers: IL-2
Time Frame: 12 weeks
All biomarkers will be assayed from banked plasma using a Luminex multiplex assay and ELISAs performed per manufacturer's instructions. A Cytokine 10-Plex Human Panel (ThermoFisher Scientific) with data acquired using Luminex 200TM system (Luminex) and ELISAs (ThermoFisher Scientific) with data acquired using a Victor X3 plate reader (PerkinElmer) will be utilized to measure the following inflammatory biomarkers: IL-2. Cytokine standards supplied by the manufacturer will be run in duplicate on each plate.
12 weeks
Change in Inflammatory Markers: IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10
Time Frame: 12 weeks
All biomarkers will be assayed from banked plasma using a Luminex multiplex assay and ELISAs performed per manufacturer's instructions. A Cytokine 10-Plex Human Panel (ThermoFisher Scientific) with data acquired using Luminex 200TM system (Luminex) and ELISAs (ThermoFisher Scientific) with data acquired using a Victor X3 plate reader (PerkinElmer) will be utilized to measure the following inflammatory biomarkers: IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10. Cytokine standards supplied by the manufacturer will be run in duplicate on each plate.
12 weeks
Change in Inflammatory Markers: TNF-α
Time Frame: 12 weeks
All biomarkers will be assayed from banked plasma using a Luminex multiplex assay and ELISAs performed per manufacturer's instructions. A Cytokine 10-Plex Human Panel (ThermoFisher Scientific) with data acquired using Luminex 200TM system (Luminex) and ELISAs (ThermoFisher Scientific) with data acquired using a Victor X3 plate reader (PerkinElmer) will be utilized to measure the following inflammatory biomarkers: TNF-α. Cytokine standards supplied by the manufacturer will be run in duplicate on each plate.
12 weeks
Change in Inflammatory Markers: NFkB
Time Frame: 12 weeks
All biomarkers will be assayed from banked plasma using a Luminex multiplex assay and ELISAs performed per manufacturer's instructions. A Cytokine 10-Plex Human Panel (ThermoFisher Scientific) with data acquired using Luminex 200TM system (Luminex) and ELISAs (ThermoFisher Scientific) with data acquired using a Victor X3 plate reader (PerkinElmer) will be utilized to measure the following inflammatory biomarkers: NFkB. Cytokine standards supplied by the manufacturer will be run in duplicate on each plate.
12 weeks
Change in Inflammatory Markers: sCD163, and sCD14
Time Frame: 12 weeks
All biomarkers will be assayed from banked plasma using a Luminex multiplex assay and ELISAs performed per manufacturer's instructions. A Cytokine 10-Plex Human Panel (ThermoFisher Scientific) with data acquired using Luminex 200TM system (Luminex) and ELISAs (ThermoFisher Scientific) with data acquired using a Victor X3 plate reader (PerkinElmer) will be utilized to measure the following inflammatory biomarkers: sCD163, and sCD14. Cytokine standards supplied by the manufacturer will be run in duplicate on each plate.
12 weeks
Body composition
Time Frame: 12 weeks
Body composition (total, peripheral and truncal fat, and lean tissue) by dual energy absorptiometry (DEXA)
12 weeks
Waist circumference
Time Frame: 12 weeks
Changes in waist circumference over 12 weeks of therapy
12 weeks
Liver fat content
Time Frame: 12 weeks
Changes in Liver fat content (Controlled Attenuation Parameter, CAP) over 12 weeks
12 weeks
Liver stiffness measurement (LSM)
Time Frame: 12 weeks
Changes in Liver stiffness measurement (LSM) over 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biorepository samples for future research
Time Frame: The biorepository samples (only) will be banked for future analysis for separate research (related or unrelated to this project) for up to 7 years post-study completion.
Obtaining blood specimens for banking in the biorepository for future analyses (frozen for retrospective analysis) related to HIV, cardiometabolic diseases, inflammation and the immune system. Biorespository specimens will be collected at baseline, week 12, week 16 and early discontinuation visits. It will not include genetic testing. The biorepository will enable the development of new hypotheses to further contribute toward understanding of HIV, the immune system, chronic inflammation, and cardiometabolic disease.
The biorepository samples (only) will be banked for future analysis for separate research (related or unrelated to this project) for up to 7 years post-study completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hawaii

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H064
  • U54GM138062 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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