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Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

14:28 EDT 17th April 2014 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Nonalcoholic Steatohepatitis

Intervention

Colesevelam Hcl

Location

UCSD: Prevention Studies Clinic
La Jolla
California
United States
92093

Status

Enrolling by invitation

Source

University of California, San Diego

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

None available.

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