Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066364
• Other study ID #: 091491
• Status: Completed
• Phase: Phase 2
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: July 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age at entry at least 18 years.

2. Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 19 or more in women and 30 or more in men.

3. Evidence of hepatic steatosis or liver fat (>5%) by MRI.

4. Evidence of definite or suspected NASH

5. Written informed consent.

Exclusion criteria:

1. Evidence of another form of liver disease.

2. History of excess alcohol ingestion.

3. Contraindications to liver biopsy.

4. Decompensated liver disease.

5. History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis.

6. Recent initiation or change of anti-diabetic drugs.

7. Use of colesevelam or other agents in the same class.

8. Significant systemic or major illnesses other than liver disease that, in the opinion of the investigator would preclude treatment with colesevelam and adequate follow up.

9. Positive test for anti-HIV.

10. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.

11. Pregnancy or inability to practice adequate contraception in women of childbearing potential.

12. Evidence of hepatocellular carcinoma

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• Colesevelam Hcl
3.75 gm/day (six 675 mg tablets)

Locations

Country	Name	City	State
United States	UCSD: Prevention Studies Clinic	La Jolla	California
United States	UCSD: Medical Center- Hillcrest	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Daiichi Sankyo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI	To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease liver fat in patients with biopsy-proven nonalcoholic steatohepatitis.	24 weeks
Secondary	Insulin Sensitivity as Determined by HOMA-IR	To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease HOMA-IR in patients with biopsy-proven nonalcoholic steatohepatitis.	24 weeks
Secondary	Serum ALT and AST Values	To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease serum ALT and AST in patients with biopsy-proven nonalcoholic steatohepatitis.	24 weeks
Secondary	Lipid Profiles	To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease improve the lipid profiles in patients with biopsy-proven nonalcoholic steatohepatitis.	24 weeks