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Study in humans · 2010 · cited for Tesamorelin

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

Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, et al. The Journal of clinical endocrinology and metabolism 2010;95(9):4291-304. doi:10.1210/jc.2010-0490 · PubMed 20554713

In brief

This paper pools the two phase-3 trials of tesamorelin in HIV-associated abdominal fat. Over the first 26 weeks visceral adipose tissue fell by 24 square centimetres on tesamorelin against a rise of 2 on placebo, a treatment effect of about 15 percent, while abdominal subcutaneous fat did not change. Triglycerides fell, and patients reported better body image. In the extension, patients who stayed on tesamorelin for 52 weeks kept their reductions in visceral fat, waist circumference, triglycerides, cholesterol and non-HDL cholesterol; those switched to placebo did not. Tesamorelin was generally well tolerated, and there were no clinically meaningful differences in glucose measures between the groups at 26 or 52 weeks. The authors conclude the effect is maintained while treatment continues.

Study design

Pooled analysis of two phase-3 trials: 806 ART-treated HIV patients with excess abdominal fat, 2:1 to daily tesamorelin or placebo for 26 weeks, then a 26-week re-randomised safety extension.

What it does not show

The same specific population as the primary trial, and the fat loss reversed in patients switched to placebo, which the paper reports. It is an analysis of pharmaceutical tesamorelin under trial conditions.

A clinical trial tests a pharmaceutical form of a compound, in a defined patient group, under medical supervision, with a defined endpoint. None of that transfers to a research-grade vial, and this page does not suggest it does.

Where this paper is cited

  • Tesamorelin — Pooled analysis of two phase 3 trials: the visceral fat reduction held through 52 weeks of continued treatment and reversed on withdrawal.

Other papers cited for Tesamorelin

Further reading

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Research use only This page summarises a published paper. It is not a claim that any product sold by Zyrna Research does what the paper describes, the trial used a pharmaceutical product under medical supervision, and nothing here is dosing guidance. Nothing sold by Zyrna Research is for human or veterinary use.