Skip to content

Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT06935838 (opens ClinicalTrials.gov in a new tab)Other idH064Other idU54GM138062
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
12 participants (actual)
Sponsor
University of Hawaii · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
12 Nov 2025
Primary completion
2 Jun 2026
Completion
2 Jun 2026
First posted
20 Apr 2025
Last update posted
8 Jul 2026
Conditions
Obesity and Overweight · HIV · Chronic Inflammation

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 2

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

    NCT06935838

    12 Nov 2025 to 2 Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug

Arms1

  • Experimental

    Tirzepatide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Baseline Body Weight

    Time frame · 12 weeks

    Registry description

    The primary outcome will be the change in baseline body weight (measured in lbs) at 12 weeks.

Secondary outcomes(14)

  1. Change in Inflammatory Markers: GM-CSF

    Time frame · 12 weeks

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

  12. Waist circumference

    Time frame · 12 weeks

    Registry description

    Changes in waist circumference over 12 weeks of therapy

  13. Liver fat content

    Time frame · 12 weeks

    Registry description

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

  14. Liver stiffness measurement (LSM)

    Time frame · 12 weeks

    Registry description

    Changes in Liver stiffness measurement (LSM) over 12 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

6 results

Tirzepatide Once Weekly for the Treatment of Obesity.

Jastreboff et al. 2022The New England journal of medicinecited by 2,802

PMID 35658024DOI 10.1056/nejmoa2206038PUB-35658024

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

1 study on this page

PubMed tag: none · 2024

Glucagon-like Peptide 1 Receptor Agonists Promote Weight Loss Among People With HIV.

Nguyen et al. 2024Clinical infectious diseases : an official publication of the Infectious Diseases Society of Americacited by 16

PMID 38501237DOI 10.1093/cid/ciae151PUB-38501237

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.