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Completed

NCT Number: NCT06935838

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

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.

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Key information

Conditions

Obesity and Overweight Body Weight Chronic Inflammation HIV Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

John A Burns School of Medicine

Honolulu, Hawaii, 96813, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Body composition

    Time frame: 12 weeks

    Body composition (total, peripheral and truncal fat, and lean tissue) by dual energy absorptiometry (DEXA)

  12. Waist circumference

    Time frame: 12 weeks

    Changes in waist circumference over 12 weeks of therapy

  13. Liver fat content

    Time frame: 12 weeks

    Changes in Liver fat content (Controlled Attenuation Parameter, CAP) over 12 weeks

  14. Liver stiffness measurement (LSM)

    Time frame: 12 weeks

    Changes in Liver stiffness measurement (LSM) over 12 weeks

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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