Currently, tesamorelin is not indicated for either of these conditions and the company’s role in this collaboration will include supplying the drug to the MGH.
The US National Institutes of Health (NIH) has provided funding for the trial following its evaluation of the efficacy of tesamorelin on reducing liver fat in HIV-infected patients with lipodystrophy.
The grant will allow Dr Steven Grinspoon of the MGH and Dr Colleen Hadigan of the National Institute of Allergy and Infectious Disease, part of NIH, to pursue research on tesamorelin in HIV-infected patients with fatty liver disease.
A total of 60 HIV-infected patients with NAFLD/NASH will be enrolled in the trial and they will receive either tesamorelin (2mg/day) or a placebo.
NAFLD can develop into a serious condition leading to liver failure, while NASH is the most severe form of fatty liver disease and can cause significant damage to liver cells including liver cirrhosis.