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Tesamorelin Reduces Visceral Fat Accumulation: Randomized Placebo-Controlled Trial
Falutz et al. (2010) conducted a randomized, placebo-controlled trial evaluating the effects of tesamorelin in HIV-infected patients with abdominal fat accumulation. In this study, participants received either tesamorelin (2 mg subcutaneously daily) or placebo for 26 weeks, followed by a safety extension. Tesamorelin treatment resulted in an approximately 18% reduction in visceral adipose tissue (VAT) while preserving subcutaneous fat. The compound also improved body image distress scores without significant side effects or clinically meaningful perturbation of glucose parameters.
Citation: Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311-322. doi:10.1097/QAI.0b013e3181cbdaff. PubMed PMID: 20101189
Pooled Analysis of Phase 3 Trials: Sustained Visceral Adipose Tissue Reduction
A pooled analysis of two multicenter, double-blind, placebo-controlled phase 3 trials by Falutz et al. (2010) evaluated tesamorelin in 806 antiretroviral-treated HIV patients with excess abdominal fat. In the primary intervention phase, tesamorelin (2 mg daily) reduced visceral adipose tissue significantly compared to placebo. Importantly, the study showed that VAT reduction was sustained for up to 52 weeks in patients who continued treatment. Tesamorelin also preserved abdominal subcutaneous adipose tissue and improved lipid profiles, including reductions in triglycerides and total cholesterol-to-HDL ratio.
Citation: Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010;95(9):4291-4304. doi:10.1210/jc.2010-0490. PubMed PMID: 20554713
Visceral Adiposity Reduction and Improved Metabolic Profile
Stanley et al. (2012) investigated whether the reduction in visceral adipose tissue (VAT) achieved by tesamorelin is directly associated with improvements in endocrine and metabolic parameters. Using data from two phase III randomized studies, the researchers analyzed 402 subjects and found that VAT reduction of 15%–20% over 6–12 months was directly associated with improvements in triglycerides, total cholesterol-to-HDL ratio, and adiponectin levels. The study provided critical evidence that tesamorelin’s metabolic benefits are mechanistically linked to visceral fat reduction rather than being independent effects of growth hormone elevation.
Citation: Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Bhatt RS, Grinspoon SK. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012;54(11):1642-1651. doi:10.1093/cid/cis251. PubMed PMID: 22495074
Tesamorelin Reduces Visceral and Liver Fat: Randomized Clinical Trial
In a randomized, double-blind, placebo-controlled trial published in JAMA, Stanley et al. (2014) investigated the effect of tesamorelin on both visceral and liver fat in 50 HIV-infected men and women with abdominal fat accumulation. Participants received tesamorelin 2 mg or placebo daily for 6 months. Tesamorelin significantly reduced visceral adipose tissue (mean change: −34 cm² vs. +8 cm² with placebo) and liver fat fraction. These findings extended the known benefits of tesamorelin beyond visceral adiposity to include hepatic fat reduction, with implications for non-alcoholic fatty liver disease (NAFLD) research.
Citation: 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. doi:10.1001/jama.2014.8334. PubMed PMID: 25038357
Tesamorelin Decreases Muscle Fat and Increases Muscle Area
Scherzinger et al. (2019) conducted an exploratory secondary analysis of a randomized controlled trial to determine the effects of tesamorelin on skeletal muscle composition. The study found that the GHRH analogue decreased intramuscular fat (myosteatosis) and increased total muscle area in adults with HIV. These changes in muscle composition occurred alongside the previously established reductions in visceral adipose tissue. The findings suggest that tesamorelin’s effects on body composition extend to favorable changes in skeletal muscle quality, which has implications for functional capacity and metabolic health research.
Citation: Scherzinger A, Sanyal A, Lake JE, Falutz J, Dubé MP, Stanley T, Grinspoon S, Mamputu JC, Marsolais C, Brown TT, Erlandson KM. The Growth Hormone Releasing Hormone Analogue, Tesamorelin, Decreases Muscle Fat and Increases Muscle Area in Adults with HIV. J Frailty Aging. 2019;8(3):154-159. doi:10.14283/jfa.2018.45. PubMed PMID: 31237318
Tesamorelin for Non-Alcoholic Fatty Liver Disease: Multicentre Trial
Stanley et al. (2019) conducted a randomized, double-blind, multicentre trial specifically evaluating tesamorelin for the treatment of non-alcoholic fatty liver disease (NAFLD) in people with HIV. Patients receiving tesamorelin had a significantly greater reduction in hepatic fat fraction (HFF) compared to placebo, with a relative reduction of 37%. More subjects in the tesamorelin arm met criteria for hepatic steatosis resolution. Follow-up analyses demonstrated that liver fat reduction tracked with lower alanine aminotransferase (ALT) levels and reduced hepatic inflammation markers, positioning tesamorelin as a potential investigational agent for NAFLD research.
Citation: Stanley TL, Fourman LT, Feldpausch MN, Purdy J, Zheng I, Pan CS, Aepfelbacher J, Buckless C, Tsao A, Kellogg DL, Branch K, Lee H, Torriani M, Corey KE, Chung RT, Grinspoon SK. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV. 2019;6(12):e821-e830. doi:10.1016/S2352-3018(19)30338-8. PubMed PMID: 31611038
Reviewed for scientific accuracy — Chameleon Peptides Research Team. Last reviewed: March 2026.