CompletedNCT01066364Updated Jul 21, 2020Results posted

Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

A Phase 2 interventional study of Colesevelam Hcl in Nonalcoholic Steatohepatitis, sponsored by University of California, San Diego. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-21.

Sponsored by University of California, San Diego · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 59
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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 studied

Nonalcoholic Steatohepatitis

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Keywords

NASH
NAFLD
Steatohepatitis
Nonalcoholic
Fatty Liver Disease

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 59 is close to the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 59 participants (actual)

Study arms

Placebo comparator
Placebo (sugar) pill
Six tablets per day (identical to colesevelam)
Drug: Colesevelam Hcl
Experimental
Colesevelam arm
3.75 grams per day
Drug: Colesevelam Hcl

Interventions

DrugColesevelam Hcl
3.75 gm/day (six 675 mg tablets)
Also known as: Welchol

What researchers measure

Primary outcomes

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.
Time frame: 24 weeks

Secondary outcomes

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.
Time frame: 24 weeks
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.
Time frame: 24 weeks
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.
Time frame: 24 weeks

Results

Posted Jul 21, 2020

Participant flow

Participant flow — Overall Study
Milestone	Placebo (Sugar) Pill	Colesevelam Arm
Started	25	25
Completed	22	23
Not completed	3	2

Outcome measures

PrimaryThe 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.

Time frame:: 24 weeks
Reported as:: Mean · % of fat

The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI
% of fat	Placebo (Sugar) Pill	Colesevelam Arm
The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI	17.9 ± 7.7	14.2 ± 6.3

SecondaryInsulin 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.

Time frame:: 24 weeks
Reported as:: Mean · units on a scale

Insulin Sensitivity as Determined by HOMA-IR
units on a scale	Placebo (Sugar) Pill	Colesevelam Arm
Insulin Sensitivity as Determined by HOMA-IR	8.3 ± 9.8	7.6 ± 12.3

SecondarySerum 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.

Time frame:: 24 weeks
Reported as:: Mean · U/L

Serum ALT and AST Values
U/L	Placebo (Sugar) Pill	Colesevelam Arm
ALT	79.1 ± 47.8	86.6 ± 68.1
AST	49.9 ± 32.1	56.2 ± 46.3

SecondaryLipid 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.

Time frame:: 24 weeks
Reported as:: Mean · mg/dL

Lipid Profiles
mg/dL	Placebo (Sugar) Pill	Colesevelam Arm
LDL	115.8 ± 31.2	124.0 ± 37.7
Total Cholesterol	202.4 ± 36.5	200.2 ± 46.0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo (Sugar) Pill	0/25 (0%)	0/25 (0%)	2/25 (8%)
Colesevelam Arm	0/25 (0%)	0/25 (0%)	1/25 (4%)

Most frequent other events

Most frequent other events
Event	Placebo (Sugar) Pill	Colesevelam Arm
Muscle ache with elevated CPKMusculoskeletal and connective tissue disorders	0/25	1/25
Severe hot flashes with leg painMusculoskeletal and connective tissue disorders	1/25	0/25
IBD ExacerbationGastrointestinal disorders	1/25	0/25

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo (Sugar) Pill	Colesevelam Arm	Total
Mean	50.3 ± 10.4	45.4 ± 12.7	47.8 ± 11.7

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo (Sugar) Pill	Colesevelam Arm	Total
Female	12	15	27
Male	13	10	23

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo (Sugar) Pill	Colesevelam Arm	Total
American Indian or Alaska Native	0	0	0
Asian	8	3	11
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	8	11	19
More than one race	2	2	4
Unknown or Not Reported	7	9	16

Region of Enrollment
Region of Enrollment(participants)	Placebo (Sugar) Pill	Colesevelam Arm	Total
United States	25	25	50

Study locations

2 sites

UCSD: Prevention Studies Clinic
La Jolla, California 92093, United States
UCSD: Medical Center- Hillcrest
San Diego, California 92103, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01066364
Lead sponsor: University of California, San Diego
Collaborators: Daiichi Sankyo
Responsible party: Rohit Loomba (Professor, University of California, San Diego) — Principal investigator
First posted: Feb 10, 2010
Start date: Feb 2010
Primary completion: Feb 2012
Completion: Feb 2012
Results posted: Jul 21, 2020
Last update: Jul 21, 2020

Study contacts

Rohit Loomba, MD, M.H.Sc

principal investigator · University of California, San Diego

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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