Clinical trial NCT01066364: Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
Official title: Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Keywords: NASH
NAFLD
Steatohepatitis
Nonalcoholic
Fatty Liver Disease
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo
First posted: 2010-02-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI
timeFrame: 24 weeks
Secondary outcomes:
measure: Insulin Sensitivity as Determined by HOMA-IR
timeFrame: 24 weeks
measure: Serum ALT and AST Values
timeFrame: 24 weeks
measure: Lipid Profiles
timeFrame: 24 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD: Prevention Studies Clinic
state: California
city: San Diego
country: United States
facility: UCSD: Medical Center- Hillcrest
state: California
Study officials:
affiliation: University of California, San Diego
name: Rohit Loomba, MD, M.H.Sc
role: PRINCIPAL_INVESTIGATOR
References: