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

Stopped early · Phase 2

Conditions studied: Nonalcoholic Fatty Liver Disease (NAFLD)

In brief

The purpose of this research is to gather information on the combination Zetia® (Ezetimibe) and Urso Forte® with respect to sterol balance and their effects on biomarkers of liver function in subjects with nonalcoholic fatty liver disease (NAFLD).

Key facts

Study ID

NCT02244944

Run by

Gregory Graf, PhD

People needed

2

Starts

2014-09-01

Expected to finish

2015-09-01

Last updated by the study team

2018-02-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Steatosis
• ALT >1.5 times normal
• ALT/AST ratio >1.0
• Normal Kidney Function

You may not qualify if…

• Normal ALT within last 6 months
• Advanced fibrosis based on 1) biopsy, if available (Stage 3 or 4 NAFLD), 2) imaging, or 3) lab (platelet count <150,000)
• Daily alcohol use above 20 g/day for women and 30 g/day for men
• Prescription use of ursodiol, ezetimibe, vitamin E, fish oils, thiazolidinediones, insulin, sulfonylureas, HMG-CoA reductase inhibitors
• Weight loss greater than 15% in past 12 months
• Pregnant or breastfeeding
• Body Mass index greater than 50
• Largest body circumference greater than 160 cm
• Claustrophobia
• Allergy to ezetimibe or ursodiol

Where it is running

• University of Kentucky Medical Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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