Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
NCT ID: NCT06935838
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
12 participants
INTERVENTIONAL
2025-11-12
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tirzepatide
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of Hawaii
OTHER
Responsible Party
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Christine Akamine
Assistant Professor
Locations
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John A Burns School of Medicine
Honolulu, Hawaii, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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H064
Identifier Type: -
Identifier Source: org_study_id
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