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

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ClinicalTrials.gov Identifier: NCT00529204
Recruitment Status : Terminated (Lack of recruitment)
First Posted : September 14, 2007
Results First Posted : December 22, 2014
Last Update Posted : June 20, 2017
Sponsor:
Collaborators:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes Complications
Fatty Liver
Intervention Drug: exenatide
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exenatide
Hide Arm/Group Description

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

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Exenatide
Hide Arm/Group Description

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

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Alanine aminotransferase  
Mean (Full Range)
Unit of measure:  IU
Number Analyzed 1 participants
84
Glucose  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 1 participants
139
Cholesterol  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 1 participants
317
HDL  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 1 participants
31
Triglyceride  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 1 participants
482
hsCRP  
Mean (Full Range)
Unit of measure:  mg/L
Number Analyzed 1 participants
8.2
Weight  
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 1 participants
72.3
HbA1c  
Mean (Full Range)
Unit of measure:  %
Number Analyzed 1 participants
8.1
1.Primary Outcome
Title Reduction in Serum ALT From Baseline to 24 Weeks of Exenatide Therapy
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: IU
61
2.Secondary Outcome
Title Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis
Hide Description

Steatosis was grades on a scale of 0 (< 5%); 1 (5%- 33%); 2 (> 33% - 66%); and 3 (> 66%).

Inflammation was graded on a scale of 0 (No foci); 1 (< 2 foci per 200 X field); 2 (2-4 foci per 200 X field); and 3 (>4 foci per 200 X field) Fibrosis was graded on a scale of 0 (None); 1 (Mild periportal or perisinusoidal); 2 (Moderate periportal or perisinusoidal); 3 (Bridging fibrosis); and 4 (cirrhosis)

Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
steatosis -1
inflammation -1
fibrosis 0
3.Secondary Outcome
Title Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: adverse events
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide
Hide Arm/Group Description

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

All-Cause Mortality
Exenatide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exenatide
Affected / at Risk (%)
Total   0/1 (0.00%) 
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
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00529204     History of Changes
Other Study ID Numbers: 200715325
H80-MC-X006 ( Other Identifier: UC Davis )
First Submitted: September 12, 2007
First Posted: September 14, 2007
Results First Submitted: December 8, 2014
Results First Posted: December 22, 2014
Last Update Posted: June 20, 2017