Nonalcoholic Steatohepatitis Clinical Trial
Official title:
Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).
We plan to investigate the role of colesevelam, a bile-acid binding resin, in patients with
NASH residing in the United States and assess liver fat changes during therapy using MRI of
the liver. It can be hypothesized that colesevelam would lead to a greater improvement in
insulin sensitivity and lipid profile compared with placebo and may lead to greater
improvement in liver fat by MRI as compared to placebo.
In this pilot study, we propose to randomize approximately 55 patients (1:1 ratio) to either
colesevelam or placebo and treat them for 24-weeks to evaluate changes in baseline insulin
sensitivity, serum biochemistry (ALT and AST), and liver fat by MRI during therapy. Liver
histologic changes would also be examined as an exploratory outcome for future studies.
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