Product Overview

Tesamorelin clinical summary

Tesamorelin is a synthetic growth hormone–releasing hormone (GHRH) analogue approved for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. It stimulates pituitary GH secretion, increasing IGF-I and driving downstream metabolic effects.[1][2][3]

Growth hormone release & IGF-I elevation

Daily s.c. tesamorelin (2 mg) significantly raises circulating GH and IGF-I; IGF-I increases by ~81% over 26 weeks in HIV-infected patients, with effects maintained during therapy.[4][5][6]

Visceral fat reduction

Tesamorelin selectively reduces visceral adipose tissue (VAT) by ~15–20% over 6–12 months in HIV-associated lipodystrophy, with minimal impact on subcutaneous fat; VAT reduction is sustained while on treatment and reverses after discontinuation. Odds of achieving VAT < 140 cm² are ~4× higher vs placebo; efficacy is similar on integrase inhibitor–based ART.[5][4][2][6][7][8][3][9][10]

Lean muscle & body composition

Improvements in trunk fat, waist circumference, and waist–hip ratio occur without significant loss of limb/subcutaneous fat. Some studies show favorable shifts in trunk-to-appendicular fat ratio and hepatic fat fraction.[5][2][3][10]

Metabolic & lipid profile

VAT reduction correlates with lower triglycerides (~50 mg/dL at 26 weeks), improved total-cholesterol/HDL ratio, and higher adiponectin, with neutral effects on glucose parameters/HbA1c in trials.[11][4][6]

Cardiovascular health

Tesamorelin reduces carotid intima-media thickness (cIMT) and C-reactive protein in settings of reduced GH secretion and in HIV-infected patients, suggesting CV risk benefit.[12][4]

Physical performance & well-being

Trials consistently report improvements in body-image distress, belly appearance, and overall well-being; lean mass gains and VAT loss may contribute to functional benefits.[5][2][3]

Safety & tolerability

Generally well tolerated with AE rates comparable to placebo; common events include mild injection-site reactions, arthralgia, headache, and peripheral edema. Long-term studies show no major glucose liability or serious AEs attributable to treatment.[4][2][6][3]

Dosage

  • Approved dose: 2 mg s.c. once daily for HIV-associated lipodystrophy.[1][8]
  • Other formulations: Lower doses (1.28–1.4 mg) used in some products with similar VAT reduction reported.[1][8]

Summary: Tesamorelin (10 mg) is a GHRH analogue with strong evidence for selective VAT reduction, improved lipid/metabolic profiles, favorable body composition changes, potential cardiovascular benefits, and a well-established safety profile in HIV-associated lipodystrophy and in obese adults with reduced GH secretion.[12][1][9][11][10][5][4][2][6][7][8][3]

References

  1. EGRIFTA SV. Food and Drug Administration. Updated 2024-12-12.
  2. Dhillon S. Drugs. 2011;71(8):1071-91.
  3. Spooner LM, Olin JL. Ann Pharmacother. 2012;46(2):240-7.
  4. Falutz J, Allas S, Blot K, et al. NEJM. 2007;357:2359-70.
  5. Falutz J, Potvin D, Mamputu JC, et al. JAIDS. 2010;53(3):311-22.
  6. Falutz J, Allas S, Mamputu JC, et al. AIDS. 2008;22(14):1719-28.
  7. Falutz J, Allas S, Blot K, et al. NEJM. 2007;357:2359-70.
  8. EGRIFTA WR. FDA. Updated 2025-03-31.
  9. Mangili A, Falutz J, Mamputu JC, et al. PLOS One. 2015;10(10):e0140358.
  10. Russo SC, Ockene MW, Arpante AK, et al. AIDS. 2024;38(12):1758-1764.
  11. Stanley TL, Falutz J, Marsolais C, et al. Clin Infect Dis. 2012;54(11):1642-51.
  12. Makimura H, Feldpausch MN, Rope AM, et al. J Clin Endocrinol Metab. 2012;97(12):4769-79.

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