AzTrials
AzTrials

Obesity and OverweightPhase 2NCT06935838

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

A Phase 2 study testing Tirzepatide in people with Obesity and Overweight and HIV, run by University of Hawaii at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity and Overweight, HIV, Chronic Inflammation
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
12 Nov 2025to 2 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • John A Burns School of Medicine

    Honolulu, Hawaii, 96813

Other trials in United States

About this study

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.

Being tested
Tirzepatide
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    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.

Study groups in NCT06935838
Study groupRoleWhat they receive
TirzepatideExperimentalNot described
Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Baseline Body Weight

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

    Measured: 12 weeks

Secondary outcomes (14)

  1. Change in Inflammatory Markers: GM-CSF

    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.

    Measured: 12 weeks

  2. Change in cardiometabolic markers

    We will evaluate HbA1c and a lipid profile at the baseline, week 12 and week 16 study visits.

    Measured: 12 weeks

  3. Monocyte Subset Analysis

    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.

    Measured: Week 12 and week 16

  4. Change in Inflammatory Markers: IFN-γ

    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.

    Measured: 12 weeks

  5. Change in Inflammatory Markers: IL-1β

    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.

    Measured: 12 weeks

  6. Change in Inflammatory Markers: IL-2

    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.

    Measured: 12 weeks

  7. Change in Inflammatory Markers: IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10

    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.

    Measured: 12 weeks

  8. Change in Inflammatory Markers: TNF-α

    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.

    Measured: 12 weeks

  9. Change in Inflammatory Markers: NFkB

    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.

    Measured: 12 weeks

  10. Change in Inflammatory Markers: sCD163, and sCD14

    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.

    Measured: 12 weeks

  11. Body composition

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

    Measured: 12 weeks

  12. Waist circumference

    Changes in waist circumference over 12 weeks of therapy

    Measured: 12 weeks

  13. Liver fat content

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

    Measured: 12 weeks

  14. Liver stiffness measurement (LSM)

    Changes in Liver stiffness measurement (LSM) over 12 weeks

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2025
  2. Study start12 Nov 2025
  3. Primary completion2 Jun 2026
  4. Study completion2 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06935838
Sponsor's protocol ID
H064
Other IDs
U54GM138062
Status last verified
Jul 2026
First submitted
4 Apr 2025
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Morisako AK, Tauali'i M, Ambrose AJH, Withy K. Beyond the Ability to Pay: The Health Status of Native Hawaiians and Other Pacific Islanders in Relationship to Health Insurance. Hawaii J Med Public Health. 2017 Mar;76(3 Suppl 1):36-41.

    PubMed 28435757

  • Hoagland A, Kipping S. Challenges in Promoting Health Equity and Reducing Disparities in Access Across New and Established Technologies. Can J Cardiol. 2024 Jun;40(6):1154-1167. doi: 10.1016/j.cjca.2024.02.014. Epub 2024 Feb 28.

    PubMed 38417572

  • Liang H, Xie Z, Shen T. Monocyte activation and cardiovascular disease in HIV infection. Cell Mol Immunol. 2017 Dec;14(12):960-962. doi: 10.1038/cmi.2017.109. Epub 2017 Oct 30. No abstract available.

    PubMed 29082920

  • Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U, Ryan DH, Still CD; Endocrine Society. Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015 Feb;100(2):342-62. doi: 10.1210/jc.2014-3415. Epub 2015 Jan 15.

    PubMed 25590212

  • Wharton S, Lau DCW, Vallis M, Sharma AM, Biertho L, Campbell-Scherer D, Adamo K, Alberga A, Bell R, Boule N, Boyling E, Brown J, Calam B, Clarke C, Crowshoe L, Divalentino D, Forhan M, Freedhoff Y, Gagner M, Glazer S, Grand C, Green M, Hahn M, Hawa R, Henderson R, Hong D, Hung P, Janssen I, Jacklin K, Johnson-Stoklossa C, Kemp A, Kirk S, Kuk J, Langlois MF, Lear S, McInnes A, Macklin D, Naji L, Manjoo P, Morin MP, Nerenberg K, Patton I, Pedersen S, Pereira L, Piccinini-Vallis H, Poddar M, Poirier P, Prud'homme D, Salas XR, Rueda-Clausen C, Russell-Mayhew S, Shiau J, Sherifali D, Sievenpiper J, Sockalingam S, Taylor V, Toth E, Twells L, Tytus R, Walji S, Walker L, Wicklum S. Obesity in adults: a clinical practice guideline. CMAJ. 2020 Aug 4;192(31):E875-E891. doi: 10.1503/cmaj.191707. No abstract available.

    PubMed 32753461

  • Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4.

    PubMed 35658024

  • Nguyen Q, Wooten D, Lee D, Moreno M, Promer K, Rajagopal A, Tan M, Tang M, Duren K, Yin J, Hill L. Glucagon-like Peptide 1 Receptor Agonists Promote Weight Loss Among People With HIV. Clin Infect Dis. 2024 Oct 15;79(4):978-982. doi: 10.1093/cid/ciae151.

    PubMed 38501237

  • Crum-Cianflone N, Tejidor R, Medina S, Barahona I, Ganesan A. Obesity among patients with HIV: the latest epidemic. AIDS Patient Care STDS. 2008 Dec;22(12):925-30. doi: 10.1089/apc.2008.0082.

    PubMed 19072098

  • Lv T, Cao W, Li T. HIV-Related Immune Activation and Inflammation: Current Understanding and Strategies. J Immunol Res. 2021 Sep 29;2021:7316456. doi: 10.1155/2021/7316456. eCollection 2021.

    PubMed 34631899

  • Lenharo M. Obesity drugs have another superpower: taming inflammation. Nature. 2024 Feb;626(7998):246. doi: 10.1038/d41586-024-00118-4. No abstract available.

    PubMed 38278941

  • Todosenko N, Khaziakhmatova O, Malashchenko V, Yurova K, Bograya M, Beletskaya M, Vulf M, Mikhailova L, Minchenko A, Soroko I, Khlusov I, Litvinova L. Adipocyte- and Monocyte-Mediated Vicious Circle of Inflammation and Obesity (Review of Cellular and Molecular Mechanisms). Int J Mol Sci. 2023 Jul 31;24(15):12259. doi: 10.3390/ijms241512259.

    PubMed 37569635

  • Sotak M, Clark M, Suur BE, Borgeson E. Inflammation and resolution in obesity. Nat Rev Endocrinol. 2025 Jan;21(1):45-61. doi: 10.1038/s41574-024-01047-y. Epub 2024 Oct 24.

    PubMed 39448830

  • Yanovski SZ, Yanovski JA. Approach to Obesity Treatment in Primary Care: A Review. JAMA Intern Med. 2024 Jul 1;184(7):818-829. doi: 10.1001/jamainternmed.2023.8526.

    PubMed 38466272

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirzepatide in people with Obesity and Overweight and HIV, run by University of Hawaii at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Baseline Body Weight (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06935838, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in