Trial Outcomes & Findings for Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis (NCT NCT01766713)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Baseline, 24 weeks

Results posted on

2020-07-14

Participant milestones
Measure	Ezetimibe 10 mg/day of Ezetimibe Ezetimibe	Placebo Placebo identical to ezetimibe
Overall Study STARTED	25	25
Overall Study COMPLETED	23	22
Overall Study NOT COMPLETED	2	3

Withdrawal data not reported

Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis

Baseline characteristics by cohort
Measure	Ezetimibe n=25 Participants 10 mg/day of Ezetimibe Ezetimibe	Placebo n=25 Participants Placebo only	Total n=50 Participants Total of all reporting groups
Age, Continuous	49.0 years STANDARD_DEVIATION 14.9 • n=5 Participants	49.5 years STANDARD_DEVIATION 13.7 • n=7 Participants	49.5 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants

Timeframe: Baseline, 24 weeks

Population: compared to baseline, end of treatment MRI-PDFF

Outcome measures
Measure	Ezetimibe n=23 Participants 10 mg/day of Ezetimibe Ezetimibe	Placebo n=22 Participants Placebo identical to ezetimibe
Change in Liver Fat as Measured by MRI-PDFF Baseline	15.0 percentage of total fat Standard Deviation 8.7	18.5 percentage of total fat Standard Deviation 8.0
Change in Liver Fat as Measured by MRI-PDFF week 24	11.6 percentage of total fat Standard Deviation 6.9	16.4 percentage of total fat Standard Deviation 6.1

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events
Measure	Ezetimibe n=25 participants at risk 10 mg/day of Ezetimibe Ezetimibe	Placebo n=25 participants at risk Placebo identical to 10 mg/day of Ezetimibe
Gastrointestinal disorders Gall bladder perforation	4.0% 1/25 • Number of events 1	0.00% 0/25

Other adverse events
Measure	Ezetimibe n=25 participants at risk 10 mg/day of Ezetimibe Ezetimibe	Placebo n=25 participants at risk Placebo identical to 10 mg/day of Ezetimibe
Gastrointestinal disorders GI issues	8.0% 2/25 • Number of events 2	8.0% 2/25 • Number of events 2
General disorders Muscle soreness	8.0% 2/25 • Number of events 2	4.0% 1/25 • Number of events 1

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