Trial Outcomes & Findings for Effects Of Exenatide On Liver Biochemistry, Liver Histology And Lipid Metabolism In Patients With Fatty Liver Disease (NCT NCT00529204)

NCT ID: NCT00529204

Last Updated: 2017-06-20

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2017-06-20

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Exenatide n=1 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Alanine aminotransferase	84 IU n=5 Participants
Glucose	139 mg/dL n=5 Participants
Cholesterol	317 mg/dL n=5 Participants
HDL	31 mg/dL n=5 Participants
Triglyceride	482 mg/dL n=5 Participants
hsCRP	8.2 mg/L n=5 Participants
Weight	72.3 kg n=5 Participants
HbA1c	8.1 % n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Exenatide n=1 Participants 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
Reduction in Serum ALT From Baseline to 24 Weeks of Exenatide Therapy	61 IU

SECONDARY outcome

Timeframe: 24 weeks

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)

Outcome measures

Measure	Exenatide n=1 Participants 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
Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis steatosis	-1 units on a scale
Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis inflammation	-1 units on a scale
Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis fibrosis	0 units on a scale

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Exenatide n=1 Participants 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
Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes	0 adverse events

Adverse Events

Exenatide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher L. Bowlus, MD

University of California Davis Medical Center

Phone: 916-734-8986

Email: chris.bowlus@ucdmc.ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place