# Tesamorelin References: The Cited Trial and Label Record

> The full tesamorelin reference list — pivotal Phase 3 trials, the JAMA hepatic-fat RCT, healthy-men mechanism study, NAFLD pathway proteomics, the FDA label, LiverTox, and the 2026 meta-analysis.

Every figure on this site resolves to a study below. Peer-reviewed trials, the FDA-approved labeling, and the NIH drug-safety monograph, with PMIDs and DOIs.

## How to read this list

Each entry carries the citation, a DOI where one exists, and a PubMed or NCBI URL. Inline markers like [3] throughout the site map to the numbered entries here. The list spans the pivotal Phase 3 program, the hepatic-fat and NAFLD-pathway studies, the mechanistic healthy-men data, the FDA-approved labeling, the NIH LiverTox monograph, and the 2026 meta-analysis.

## References

[1] Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357(23):2359-2370. https://pubmed.ncbi.nlm.nih.gov/18057338/
[2] Falutz J, Allas S, Mamputu JC, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS. 2008;22(14):1719-1728. https://pubmed.ncbi.nlm.nih.gov/18690162/
[3] Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, Grinspoon SK. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014;312(4):380-389. https://pubmed.ncbi.nlm.nih.gov/25038357/
[4] Stanley TL, Chen CY, Branch KL, Makimura H, Grinspoon SK. Effects of a growth hormone-releasing hormone analog on endogenous GH pulsatility and insulin sensitivity in healthy men. J Clin Endocrinol Metab. 2011;96(1):150-158. https://pubmed.ncbi.nlm.nih.gov/20943777/
[5] National Institute of Diabetes and Digestive and Kidney Diseases. Tesamorelin. In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. Bethesda (MD): NCBI Bookshelf (NIH); 2018. https://www.ncbi.nlm.nih.gov/books/NBK548730/
[6] Stanley TL, et al. Growth Hormone Releasing Hormone Reduces Circulating Markers of Immune Activation in Parallel with Effects on Hepatic Immune Pathways in Individuals with HIV-infection and Nonalcoholic Fatty Liver Disease. Clin Infect Dis. 2021;73:621-630. https://pubmed.ncbi.nlm.nih.gov/33852720/
[7] Braun LR, et al. Fibroblast growth factor 21 decreases after liver fat reduction via growth hormone augmentation. Growth Horm IGF Res. 2017;37:1-6. https://pubmed.ncbi.nlm.nih.gov/29031905/
[8] Fourman LT, Stanley TL, Billingsley JM, et al. Delineating tesamorelin response pathways in HIV-associated NAFLD using a targeted proteomic and transcriptomic approach. Sci Rep. 2021;11:10485. https://pubmed.ncbi.nlm.nih.gov/34006921/
[9] Fourman LT, Stanley TL, Zheng I, et al. Clinical Predictors of Liver Fibrosis Presence and Progression in Human Immunodeficiency Virus-Associated Nonalcoholic Fatty Liver Disease. Clin Infect Dis. 2021;72:2087-2094. https://pubmed.ncbi.nlm.nih.gov/32270862/
[10] Fourman LT, Stanley TL, Ockene MW, et al. Proteomic Analysis of Hepatic Fibrosis in Human Immunodeficiency Virus-Associated Nonalcoholic Fatty Liver Disease Demonstrates Up-regulation of Immune Response and Tissue Repair Pathways. J Infect Dis. 2023;227:565-576. https://pubmed.ncbi.nlm.nih.gov/36461941/
[11] Spooner LM, Olin JL. Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy. Ann Pharmacother. 2012;46(2):240-247. https://pubmed.ncbi.nlm.nih.gov/22298602/
[12] Wang Y, Tomlinson B. Tesamorelin, a human growth hormone releasing factor analogue. Expert Opin Investig Drugs. 2009;18:303-310. https://pubmed.ncbi.nlm.nih.gov/19243281/
[13] Theratechnologies Inc. (FDA-approved labeling). Tesamorelin for injection — Full Prescribing Information. U.S. FDA Prescribing Information (NDA 022505); 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf
[14] Veldhuis JD, Erickson D, et al. Endogenous Estrogen Regulates Somatostatin-Induced Rebound GH Secretion in Postmenopausal Women. J Clin Endocrinol Metab. 2016;101:4298-4304. https://pubmed.ncbi.nlm.nih.gov/27459535/
[15] Badran AS, et al. Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials. Obes Res Clin Pract. 2026. https://pubmed.ncbi.nlm.nih.gov/41545261/

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Tesarx files the tesamorelin record as a flat, hard-bordered data sheet — every visceral-fat and IGF-1 figure logged straight to its study, the lone HIV-lipodystrophy approval and the off-label edge ruled in plain view; an exposed-document digest, never a clinic, a pharmacy, or a prescription.