Conditions: Nonalcoholic Steatohepatitis
Keywords: NASH NAFLD Steatohepatitis Nonalcoholic Fatty Liver Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 59
Healthy volunteers: no

Brief summary:
The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).

Detailed description:
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.

Arms:
arm 1: Six tablets per day (identical to colesevelam) arm 2: 3.75 grams per day

Interventions: intervention 1: Colesevelam Hcl
Intervention descriptions: intervention 1: 3.75 gm/day (six 675 mg tablets)

Protocol document: