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

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ClinicalTrials.gov Identifier: NCT02244944
Recruitment Status : Terminated (Failure to recruit)
First Posted : September 19, 2014
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Gregory Graf, PhD, University of Kentucky

Study Description
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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).

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease (NAFLD) Drug: EZ-Urso combination therapy Phase 2

Detailed Description:

The study will be conducted as a prospective open label trial with pre- and post-treatment measures for all dependent variables. This trial will enroll subjects with a clinical diagnosis of nonalcoholic fatty liver disease (NAFLD) by magnetic resonance imaging (MRI), computed tomography (CT) or ultrasound, including those diagnosed with nonalcoholic steatohepatitis (NASH). Subjects will be consented, blood collected and a MRI conducted on the first visit. Patients will be advised on the proper use of the study drug and given the first three month's supply of the study drug to take home with them. For the remaining three months, study drug will be delivered by US mail along with return packaging for the prior three month's study medication in order to monitor compliance. Patients will be called routinely to encourage compliance, retention, and monitor side effects or adverse events. After six months of study drug administration, subjects will return for a follow-up visit. Blood will be drawn, an MRI will be obtained and a post-study questionnaire will be administered.

Duration of Patient Enrollment: 6 months Duration of Study: 18 months

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Ezetimibe-Ursodiol Combination Therapy on Biomarkers of Liver Function and Sterol Balance in Subjects With NAFLD
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: EZ-Urso combination therapy
Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day
Other Names:
  • Ezetimibe (Zetia)
  • Ursoldiol (URSO Forte)


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in Serum Alanine Transaminase (ALT) [ Time Frame: 6 months ]
    Determine if Ezetimibe-Ursodiol combination therapy improves liver function tests (ALT)


Secondary Outcome Measures :
  1. Increase in Plasma Lathosterol [ Time Frame: 6 months ]
    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.

  2. Reduction in Hepatic Fat Fraction [ Time Frame: 6 months ]
    Determine if Ezetimibe-Ursodiol combination therapy reduces total fat in the liver as assessed by MRI


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244944


Locations
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United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Gregory Graf, PhD
Investigators
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Principal Investigator: Gregory Graf, PhD University of Kentucky
More Information
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Responsible Party: Gregory Graf, PhD, PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT02244944    
Other Study ID Numbers: 13-0972-F1V
First Posted: September 19, 2014    Key Record Dates
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018
Last Verified: January 2018
Keywords provided by Gregory Graf, PhD, University of Kentucky:
nonalcoholic fatty liver disease
NAFLD
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Ezetimibe
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents