Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial

What Was Tested

This randomized controlled trial paper looks at Tesamorelin and GHRH (Growth Hormone-Releasing Hormone) in the context of fatty liver & elevated liver enzymes.

The researchers assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD.

National Institutes of Health and National Institute of Allergy and Infectious Diseases.

Who Took Part

PubMed indexes the participants as adults, middle-aged adults and older adults, both men and women.

How the Study Was Run

The researchers set it up as a randomized, double-blind, open-label, placebo-controlled and multicenter study.

Random assignment meant chance, not the researchers, decided who got Tesamorelin and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received Tesamorelin.

Nothing was hidden in this open-label Tesamorelin study: the participants and staff both knew the treatment.

Some participants received a placebo instead of Tesamorelin, giving a reference point.

This randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA.

The randomisation list was prepared by the study statistician using a permuted block algorithm within each stratum with randomly varying block sizes.

The primary endpoint was change in HFF between baseline and 12 months.

The primary safety endpoint was glucose.

Analysis was by intention to treat using all available data.

What Was Measured

The researchers assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD.

Topics PubMed links to this paper include Growth Hormone-Releasing Hormone, HIV Infections, Liver, Non-alcoholic Fatty Liver Disease and United States.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Tesamorelin and GHRH (Growth Hormone-Releasing Hormone) in people with fatty liver & elevated liver enzymes.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2019 (The lancet. HIV), a journal based in Netherlands.

More context: the Tesamorelin compound page and the GHRH (Growth Hormone-Releasing Hormone) compound page, Fatty liver & elevated liver enzymes research.