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

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 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.

Timeline

Start

2025-11-12

Primary completion

2026-06-02

Completion

2026-06-02

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.

Drugs

Indications