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Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis

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ClinicalTrials.gov Identifier: NCT01766713
Recruitment Status : Completed
First Posted : January 11, 2013
Results First Posted : December 18, 2014
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
Rohit Loomba, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Non Alcoholic Steatohepatitis
Intervention Drug: Ezetimibe
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ezetimibe Placebo
Hide Arm/Group Description

10 mg/day of Ezetimibe

Ezetimibe

Placebo
Period Title: Overall Study
Started 25 25
Completed 23 23
Not Completed 2 2
Arm/Group Title Ezetimibe Placebo Total
Hide Arm/Group Description

10 mg/day of Ezetimibe

Ezetimibe

Placebo only Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
49.0  (14.9) 49.5  (13.7) 49.5  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
14
  56.0%
17
  68.0%
31
  62.0%
Male
11
  44.0%
8
  32.0%
19
  38.0%
1.Primary Outcome
Title Change in Liver Fat as Measured by MRI-PDFF
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
compared to baseline, end of treatment MRI-PDFF
Arm/Group Title Ezetimibe Placebo
Hide Arm/Group Description:

10 mg/day of Ezetimibe

Ezetimibe

Placebo
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: percentage of total fat
Baseline 15.0  (8.7) 18.5  (8.0)
week 24 11.6  (6.9) 16.4  (6.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ezetimibe Placebo
Hide Arm/Group Description

10 mg/day of Ezetimibe

Ezetimibe

[Not Specified]
All-Cause Mortality
Ezetimibe Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ezetimibe Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      0/25 (0.00%)    
Gastrointestinal disorders     
Gall bladder perforation   1/25 (4.00%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ezetimibe Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/25 (16.00%)      3/25 (12.00%)    
Gastrointestinal disorders     
GI issues *  2/25 (8.00%)  2 2/25 (8.00%)  2
General disorders     
Muscle soreness *  2/25 (8.00%)  2 1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Rohit Loomba
Organization: UCSD
Phone: 858-534-2624
Responsible Party: Rohit Loomba, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01766713     History of Changes
Other Study ID Numbers: EZE
First Submitted: January 9, 2013
First Posted: January 11, 2013
Results First Submitted: December 10, 2014
Results First Posted: December 18, 2014
Last Update Posted: December 18, 2014