Effects Of Exenatide On Liver Biochemistry, Liver Histology And Lipid Metabolism In Patients With Fatty Liver Disease

This study has been terminated.
(Lack of recruitment)
Sponsor:
Collaborators:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
Christopher Bowlus, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00529204
First received: September 12, 2007
Last updated: December 22, 2014
Last verified: December 2014
Results First Received: December 8, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes Complications
Fatty Liver
Intervention: Drug: exenatide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Exenatide

exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24

exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24


Participant Flow:   Overall Study
    Exenatide  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Exenatide

exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24

exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24


Baseline Measures
    Exenatide  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     0  
Alanine aminotransferase  
[units: IU]
Mean (Full Range)
  84  
Glucose  
[units: mg/dL]
Mean (Full Range)
  139  
Cholesterol  
[units: mg/dL]
Mean (Full Range)
  317  
HDL  
[units: mg/dL]
Mean (Full Range)
  31  
Triglyceride  
[units: mg/dL]
Mean (Full Range)
  482  
hsCRP  
[units: mg/L]
Mean (Full Range)
  8.2  
Weight  
[units: kg]
Mean (Full Range)
  72.3  
HbA1c  
[units: %]
Mean (Full Range)
  8.1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Reduction in Serum ALT From Baseline to 24 Weeks of Exenatide Therapy   [ Time Frame: 24 weeks ]

2.  Secondary:   Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis   [ Time Frame: 24 weeks ]

3.  Secondary:   Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christopher L. Bowlus, MD
Organization: University of California Davis Medical Center
phone: 916-734-8986
e-mail: chris.bowlus@ucdmc.ucdavis.edu


Publications:

Responsible Party: Christopher Bowlus, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT00529204     History of Changes
Other Study ID Numbers: H80-MC-X006
Study First Received: September 12, 2007
Results First Received: December 8, 2014
Last Updated: December 22, 2014
Health Authority: United States: Institutional Review Board