Trial Outcomes & Findings for Ezetimibe-Ursodiol Combination Therapy on Biomarkers of Liver Function and Sterol Balance in Subjects With NAFLD (NCT NCT02244944)

Results Overview

Determine if Ezetimibe-Ursodiol combination therapy improves liver function tests (ALT)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

6 months

Results posted on

2018-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	EZ-URSO Combination Therapy Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d. EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	EZ-URSO Combination Therapy Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d. EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day
Overall Study Withdrawal by Subject	1
Overall Study Study Terminated	1

Baseline Characteristics

Ezetimibe-Ursodiol Combination Therapy on Biomarkers of Liver Function and Sterol Balance in Subjects With NAFLD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EZ-URSO Combination Therapy n=2 Participants Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d. EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The trial was terminated early. No data was collected to analyze the primary outcome measure.

Determine if Ezetimibe-Ursodiol combination therapy improves liver function tests (ALT)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: The trial was terminated early. No data was collected to analyze the secondary outcome measure.

Determine if Ezetimibe-Ursodiol combination therapy promotes a net-negative sterol balance as evidenced by an increase in the cholesterol synthesis intermediate, lathosterol, in plasma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: The trial was terminated early. No data was collected to analyze the primary outcome measure.

Determine if Ezetimibe-Ursodiol combination therapy reduces total fat in the liver as assessed by MRI

Outcome measures

Outcome data not reported

Adverse Events

EZ-URSO Combination Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EZ-URSO Combination Therapy n=2 participants at risk Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d. EZ-Urso combination therapy: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day
Gastrointestinal disorders diarrhea	50.0% 1/2 • Number of events 1

Additional Information

Gregory Graf

University of Kentucky

Phone: 8592574749

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place