NCT01066364

Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Colesevelam Hcl	3.75 gm/day (six 675 mg tablets)

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-02-10
• Last updated: 2020-07-21
• Results posted: 2020-07-21

Locations

2 sites across 1 country: United States