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Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

Primary Purpose

Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Colesevelam Hcl
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis focused on measuring NASH, NAFLD, Steatohepatitis, Nonalcoholic, Fatty Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD: Prevention Studies Clinic
  • UCSD: Medical Center- Hillcrest

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo (sugar) pill

Colesevelam arm

Arm Description

Six tablets per day (identical to colesevelam)

3.75 grams per day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 8, 2010
Last Updated
July 1, 2020
Sponsor
University of California, San Diego
Collaborators
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01066364
Brief Title
Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
Official Title
Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 2010 (Actual)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis
Keywords
NASH, NAFLD, Steatohepatitis, Nonalcoholic, Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (sugar) pill
Arm Type
Placebo Comparator
Arm Description
Six tablets per day (identical to colesevelam)
Arm Title
Colesevelam arm
Arm Type
Experimental
Arm Description
3.75 grams per day
Intervention Type
Drug
Intervention Name(s)
Colesevelam Hcl
Other Intervention Name(s)
Welchol
Intervention Description
3.75 gm/day (six 675 mg tablets)
Primary Outcome Measure Information:
Title
The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Insulin Sensitivity as Determined by HOMA-IR
Description
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.
Time Frame
24 weeks
Title
Serum ALT and AST Values
Description
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.
Time Frame
24 weeks
Title
Lipid Profiles
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age at entry at least 18 years. 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. Evidence of hepatic steatosis or liver fat (>5%) by MRI. Evidence of definite or suspected NASH Written informed consent. Exclusion criteria: Evidence of another form of liver disease. History of excess alcohol ingestion. Contraindications to liver biopsy. Decompensated liver disease. History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis. Recent initiation or change of anti-diabetic drugs. Use of colesevelam or other agents in the same class. 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. Positive test for anti-HIV. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year. Pregnancy or inability to practice adequate contraception in women of childbearing potential. Evidence of hepatocellular carcinoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohit Loomba, MD, M.H.Sc
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD: Prevention Studies Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCSD: Medical Center- Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

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Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

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