Nonalcoholic Steatohepatitis Clinical Trial
Official title:
Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy
This study involves research about an investigational medicine called metreleptin. The reason for this study is to find out how metreleptin can improve non-alcoholic steatohepatitis or nonalcoholic fatty liver disease associated with lipodystrophy, a rare disorder associated with abnormal loss of the body's fat tissue. In this study, metreleptin is considered to be investigational for the treatment of lipodystrophy. Metreleptin will be given via injections under the skin. We plan to continue therapy for a period of one year and evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body).
The goal is to test the efficacy of restorative leptin therapy on the degree of hepatic
steatosis and on amelioration of pathological features of NASH/NAFLD. In addition, the study
will evaluate the impact of leptin therapy on total body insulin sensitivity and lipid
levels as well as energy expenditure. In order to accomplish this aim, we now propose an
efficacy study with recombinant human leptin therapy in patients with all forms of
lipodystrophy who also have NASH/NAFLD.
1. AIM 1: To determine the efficacy of leptin in promoting amelioration of body
composition, hepatic steatosis and histopathological scores in patients with all forms
of lipodystrophy and NAFLD/NASH. We will conduct a 1 year, open-label study, to assess
the metabolic effects of recombinant human leptin (METRELEPTIN, AztraZeneca,
Wilmington, DE). The primary outcome measure will be NASH scores. We will also explore
body weight, insulin sensitivity, glucose and lipid control, body composition, and free
fatty acid levels.
2. AIM 2: To Investigate molecular effects of leptin therapy. In parallel to our
preliminary studies, gene expression will be performed on individuals participating in
Aim 1 at baseline and following 1 year of leptin. We will combine this with measures of
liver metabolite levels to provide novel insights into alterations in metabolism that
occur secondary to leptin therapy. We will also measure plasma metabolites at baseline
and after 2 (optional), 24 and 48 weeks of therapy to assess the dynamic changes
induced by leptin and correlate these changes with phenotypic measures.
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