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

NCT02244944 | Terminated Phase 2 Results DMC

• 1 other identifier: 13-0972-F1V
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Keywords

nonalcoholic fatty liver disease; NAFLD

Outcome Measures

Primary Outcomes (1)

• Reduction in Serum Alanine Transaminase (ALT)

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

  6 months

Secondary Outcomes (2)

• Increase in Plasma Lathosterol

  6 months

• Reduction in Hepatic Fat Fraction

  6 months

Study Arms (1)

EZ-URSO Combination Therapy

EXPERIMENTAL

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.

Drug: EZ-Urso combination therapy

Interventions

EZ-Urso combination therapy DRUG

Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day

Also known as: Ezetimibe (Zetia), Ursoldiol (URSO Forte)

EZ-URSO Combination Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Gregory Graf, PhD: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Ezetimibe; Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Results Point of Contact

• Title: Gregory Graf
• Organization: University of Kentucky

Gregory.Graf@uky.edu

8592574749

Study Officials

• Gregory Graf, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 19, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 7, 2018
• Results First Posted: February 7, 2018

Record last verified: 2018-01

Locations

US (1)