In brief
Fatty liver disease is common in people with HIV and had no proven drug treatment, so this NIH-funded trial tested tesamorelin. Sixty-one participants with a liver fat fraction of at least 5 percent on magnetic-resonance spectroscopy were randomised to daily tesamorelin or placebo for a year, with change in liver fat as the primary endpoint and glucose as the primary safety endpoint. Liver fat fell more with tesamorelin, an absolute difference of 4.1 percentage points against placebo, with a confidence interval that excluded zero. Injection-site complaints were more frequent on tesamorelin, though none was judged serious. The authors conclude that tesamorelin might benefit people with HIV and fatty liver, and that longer studies of liver histology are needed.
Study design
Randomised, double-blind, placebo-controlled trial in 61 people with HIV and non-alcoholic fatty liver disease, daily tesamorelin or placebo for 12 months, then 6 months open-label.
What it does not show
Thirty participants per arm, in HIV-positive patients only, with liver fat by imaging as the endpoint. The effect size is modest and the paper itself calls for further work.
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 — Twelve-month trial in HIV-associated liver fat: hepatic fat fraction fell and fewer participants progressed in fibrosis.
Other papers cited for Tesamorelin
- Study in humans 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 et al. (2010), J Clin Endocrinol Metab
- Study in humans Metabolic effects of a growth hormone-releasing factor in patients with HIV Falutz et al. (2007), N Engl J Med
Further reading
- Research library: every paper cited on this site, by compound and by study type.
- Growth hormone secretagogue comparison
- How to read a certificate of analysis
- Lyophilised peptide storage and stability
How this page was made: the citation was retrieved from PubMed by PMID and checked against the title on the product page; the summary was written from the paper's abstract and reports only what the abstract reports. Read the paper itself before relying on any figure here.