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Research summary4 min read

Tesamorelin research summary: GHRH analog, visceral fat, HIV-lipodystrophy clinical history

Curated summary of Tesamorelin primary literature: GHRH analog, visceral fat reduction in HIV-lipodystrophy, liver-fat outcomes, IGF-1 elevation. PubMed-verified.

By TH Labs Research Desk · Research Editor ·
Key findings
  • Tesamorelin is a stabilised GHRH(1-44) analog, FDA-approved in 2010 for HIV-associated lipodystrophy.
  • Falutz et al. (2007) established the primary visceral-fat outcome in a Phase 3 trial in HIV patients with abdominal fat accumulation.
  • Stanley et al. (2014, JAMA) demonstrated tesamorelin reduces liver fat in HIV-infected patients with VAT accumulation.
  • Long-term safety data is available through extension studies; visceral-fat reductions are not maintained after discontinuation.
  • Fourman et al. (2017) showed visceral fat reduction is associated with improved liver enzymes — a downstream metabolic benefit.

Tesamorelin is a stabilised analog of growth hormone-releasing hormone (GHRH(1-44)) modified at the N-terminus to resist enzymatic degradation. Its clinical history is unusually well-documented because the FDA-approved indication — HIV-associated lipodystrophy — drove a series of well-powered Phase 3 and extension trials.

The 2007 pivotal trial

Falutz and colleagues' 2007 New England Journal of Medicine paper 1 reported the primary Phase 3 trial: 412 HIV-infected adults with abdominal fat accumulation randomised to tesamorelin 2 mg subcutaneously daily or placebo for 26 weeks. The tesamorelin group showed a mean 15.2% reduction in visceral adipose tissue versus a 5.0% increase with placebo. Triglycerides decreased, IGF-1 increased, and adverse-event rates were comparable between groups.

Long-term safety and effect maintenance

Falutz and colleagues' 2008 AIDS paper 3 reported 52-week extension data. Patients who continued tesamorelin maintained their visceral fat reductions; patients who crossed over from placebo to active showed similar reductions to the original active group; patients who withdrew from tesamorelin lost the reduction. The clinical implication is that the visceral fat effect is treatment-maintained, not permanent.

Liver fat — the 2014 JAMA paper

Stanley and colleagues' 2014 JAMA paper 2 tested tesamorelin specifically for liver fat in HIV-infected patients with hepatic steatosis. The active arm showed a 4.1% absolute reduction in liver fat versus a 0.9% increase with placebo over 12 months. This established a second tissue-level effect of clinical relevance, particularly for the HIV-NAFLD overlap population.

Downstream metabolic benefit

Fourman and colleagues' 2017 AIDS paper 4 reanalysed the Stanley cohort to test whether visceral fat reduction translated to liver enzyme improvement. ALT and AST both decreased significantly in tesamorelin responders, supporting the mechanistic chain: GHRH-driven GH pulsatility → visceral fat reduction → improved liver fat and enzyme profile.

What tesamorelin is and is not

Tesamorelin restores endogenous GH pulsatility via stabilised GHRH signalling. It is not exogenous growth hormone, and its pharmacology preserves the physiological feedback loops that limit IGF-1 over-elevation. The well-documented clinical literature is predominantly in HIV-lipodystrophy populations; use-case generalisations to general visceral-fat reduction in non-HIV populations require their own evidence base.

For the long-form treatment, see the Tesamorelin clinical history article.

Thailand Peptides Tesamorelin 10 MG vial, clear glass with brushed aluminum cap and clear film label
Related peptide

Tesamorelin

Synthetic GHRH analog; stimulates endogenous growth-hormone pulsatility.

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Citations

  1. Falutz J, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007. PMID: 18057338
  2. Stanley TL, et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation. JAMA. 2014. PMID: 25038357
  3. Falutz J, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS. 2008. PMID: 18690162
  4. Fourman LT, et al. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS. 2017. PMID: 28832410
  5. Spooner LM, Olin JL. Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy. Ann Pharmacother. 2012. PMID: 22298602

All references verified against PubMed via NCBI E-utilities.

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This summary draws on the full-length article at /articles/tesamorelin-clinical-history. The article is the canonical long-form treatment; this page is the research-summary re-presentation.