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Lynx Peptides

Human studies

Tesamorelin

An N-terminal modification changes tesamorelin stability. Clinical preparations have been studied with visceral-fat, liver-fat and endocrine endpoints in defined HIV-associated populations.

Research summary

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.

Journal of acquired immune deficiency syndromes 2010

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

Randomised human trial

Visceral fat decreased with a defined tesamorelin preparation in a blinded trial involving 404 people with HIV-associated abdominal fat accumulation. IGF-I increased, without a significant glucose change during the initial six-month phase. Continued treatment maintained the visceral-fat reduction, whereas switching to placebo rapidly lost it. The population, clinical preparation and treatment-dependent response are central to interpreting the result.

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Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial.

JAMA 2014

Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, Grinspoon SK

Randomised human trial

Visceral fat and liver-fat measurements decreased relative to placebo in a six-month tesamorelin trial enrolling 50 adults with HIV-associated abdominal fat accumulation; 48 received study treatment. Fasting glucose rose early, although between-group glucose differences were not significant at six months. The small trial adds liver-fat context without resolving the durability or clinical importance of that change.

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Non-clinical pharmacology and safety evaluation of TH9507, a human growth hormone-releasing factor analogue.

Basic & clinical pharmacology & toxicology 2007

Ferdinandi ES, Brazeau P, High K, Procter B, Fennell S, Dubreuil P

Cellular and animal mechanistic research

The trans-3-hexenoyl modification of tesamorelin slowed degradation in rat, dog and human plasma compared with native GHRH. Animal experiments recorded prolonged endocrine responses; repeated exposure also produced reversible liver, kidney and blood-related findings in dogs. Molecular stability therefore explains part of the pharmacology without implying that longer exposure is free of biological consequences.

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Models studied

  • Growth hormone-releasing hormone signalling
  • IGF-I response
  • Body-composition imaging
  • Metabolic endpoints

Key findings

  • Stability through an N-terminal modification

    Greater plasma stability accompanied longer animal endocrine responses and reversible findings after repeated exposure in dogs.

  • Visceral fat and endocrine measurements

    Visceral-fat reduction depended on continued clinical treatment, with a distinct HIV-associated population and no initial significant glucose change.

  • Liver-fat and glucose findings

    Liver-fat and visceral-fat changes accompanied an early glucose rise that was not a significant group difference at six months.

References

  1. 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.

    Journal of acquired immune deficiency syndromes 2010

    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

    PMID 20101189

    View on PubMed

  2. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial.

    JAMA 2014

    Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, Grinspoon SK

    PMID 25038357

    View on PubMed

  3. Non-clinical pharmacology and safety evaluation of TH9507, a human growth hormone-releasing factor analogue.

    Basic & clinical pharmacology & toxicology 2007

    Ferdinandi ES, Brazeau P, High K, Procter B, Fennell S, Dubreuil P

    PMID 17214611

    View on PubMed

For laboratory research use only. Content is provided for research reference and is not intended as medical or veterinary guidance.