Trial Outcomes & Findings for Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis (NCT NCT01066364)
NCT ID: NCT01066364
Last Updated: 2020-07-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
24 weeks
Results posted on
2020-07-21
Participant Flow
Participant milestones
| Measure |
Placebo (Sugar) Pill
Six tablets per day (identical to colesevelam)
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
Colesevelam Arm
3.75 grams per day
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
Baseline characteristics by cohort
| Measure |
Placebo (Sugar) Pill
n=25 Participants
Six tablets per day (identical to colesevelam)
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
Colesevelam Arm
n=25 Participants
3.75 grams per day
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 10.4 • n=93 Participants
|
45.4 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
47.8 years
STANDARD_DEVIATION 11.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
25 participants
n=4 Participants
|
50 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 weeksTo examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease liver fat in patients with biopsy-proven nonalcoholic steatohepatitis.
Outcome measures
| Measure |
Placebo (Sugar) Pill
n=22 Participants
Six tablets per day (identical to colesevelam)
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
Colesevelam Arm
n=24 Participants
3.75 grams per day
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
|---|---|---|
|
The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI
|
17.9 % of fat
Standard Deviation 7.7
|
14.2 % of fat
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 24 weeksTo examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease HOMA-IR in patients with biopsy-proven nonalcoholic steatohepatitis.
Outcome measures
| Measure |
Placebo (Sugar) Pill
n=25 Participants
Six tablets per day (identical to colesevelam)
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
Colesevelam Arm
n=25 Participants
3.75 grams per day
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
|---|---|---|
|
Insulin Sensitivity as Determined by HOMA-IR
|
8.3 units on a scale
Standard Deviation 9.8
|
7.6 units on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: 24 weeksTo 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.
Outcome measures
| Measure |
Placebo (Sugar) Pill
n=25 Participants
Six tablets per day (identical to colesevelam)
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
Colesevelam Arm
n=25 Participants
3.75 grams per day
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
|---|---|---|
|
Serum ALT and AST Values
ALT
|
79.1 U/L
Standard Deviation 47.8
|
86.6 U/L
Standard Deviation 68.1
|
|
Serum ALT and AST Values
AST
|
49.9 U/L
Standard Deviation 32.1
|
56.2 U/L
Standard Deviation 46.3
|
SECONDARY outcome
Timeframe: 24 weeksTo 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.
Outcome measures
| Measure |
Placebo (Sugar) Pill
n=25 Participants
Six tablets per day (identical to colesevelam)
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
Colesevelam Arm
n=25 Participants
3.75 grams per day
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
|---|---|---|
|
Lipid Profiles
LDL
|
115.8 mg/dL
Standard Deviation 31.2
|
124.0 mg/dL
Standard Deviation 37.7
|
|
Lipid Profiles
Total Cholesterol
|
202.4 mg/dL
Standard Deviation 36.5
|
200.2 mg/dL
Standard Deviation 46.0
|
Adverse Events
Placebo (Sugar) Pill
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Colesevelam Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Sugar) Pill
n=25 participants at risk
Six tablets per day (identical to colesevelam)
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
Colesevelam Arm
n=25 participants at risk
3.75 grams per day
Colesevelam Hcl: 3.75 gm/day (six 675 mg tablets)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle ache with elevated CPK
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Severe hot flashes with leg pain
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
|
Gastrointestinal disorders
IBD Exacerbation
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place