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

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gregory Graf, PhD
• Treatments: Ezetimibe; Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• Steatosis

• ALT >1.5 times normal

• ALT/AST ratio >1.0

• Normal Kidney Function

Exclusion Criteria:

• 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