NCT01066364

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
8.5 years until next milestone

Results Posted

Study results publicly available

July 21, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

February 8, 2010

Results QC Date

July 1, 2020

Last Update Submit

July 1, 2020

Conditions

Nonalcoholic Steatohepatitis

Keywords

NASHNAFLDSteatohepatitisNonalcoholicFatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Insulin Sensitivity as Determined by HOMA-IR

    24 weeks

  • Serum ALT and AST Values

    24 weeks

  • Lipid Profiles

    24 weeks

Study Arms (2)

Placebo (sugar) pill

PLACEBO COMPARATOR

Six tablets per day (identical to colesevelam)

Drug: Colesevelam Hcl

Colesevelam arm

EXPERIMENTAL

3.75 grams per day

Drug: Colesevelam Hcl

Interventions

Colesevelam HclDRUG

3.75 gm/day (six 675 mg tablets)

Also known as: Welchol
Colesevelam armPlacebo (sugar) pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSD: Prevention Studies Clinic

La Jolla, California, 92093, United States

Location

UCSD: Medical Center- Hillcrest

San Diego, California, 92103, United States

Location

Related Publications (1)

  • Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1.

    PMID: 36318027DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFatty Liver

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AllylamineAminesOrganic ChemicalsAllyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbons

Results Point of Contact

Title
Rohit Loomba, MD
Organization
UCSD
roloomba@ucsd.edu
858-246-2201

Study Officials

  • Rohit Loomba, MD, M.H.Sc

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 10, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

July 21, 2020

Results First Posted

July 21, 2020

Record last verified: 2020-07

Locations

US(2)