| Trial ID: | L0679 |
| Source ID: | EUCTR2008-002325-37-DE
|
| Associated Drug: |
Exenatide
|
| Title: |
Effects of Exenatide (Byetta??) on biochemical and histological parameters of liver function in patients with Nonalcoholic Steatohepatitis (NASH) ?€? a randomized, placebo-controlled, parallel-group trial
|
| Acronym: |
--
|
| Status: |
Authorised
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non alcoholic steatohepatitis (NASH) <br>MedDRA version: 9.1
Level: LLT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
|
| Interventions: |
<br>Trade Name: Byetta<br>Product Name: Exenatide<br>Product Code: LY2148568<br>Pharmaceutical Form: Solution for injection<br>CAS Number: 141758749<br>Other descriptive name: EXENATIDE<br>Concentration unit: ??g microgram(s)<br>Concentration type: up to<
|
| Outcome Measures: |
Main Objective: The primary objective of this study is to test the hypothesis that 24 weeks of treatment with exenatide will improve the histological activity of NASH (steatosis, necroinflammation, ballooning), summarized in the recently introduced NASH-Score (appendix 1) in patients with normal, impaired or diabetic glucose tolerance compared to dietary guidance alone.;Secondary Objective: The secondary objectives are to investigate the effects of exenatide on:<br><br>?€?Enzyme activities of AST, ALT, GGT <br>?€?Liver fibrosis, as determined using the fibrosis score (appendix 3)<br>?€?Plasma levels of triglycerides, free fatty acids, cholesterol (total, HDL, LDL)<br>?€?Plasma levels of adiponectin<br>?€?Insulin sensitivity <br>?€?Hepatic mitochondrial function assessed by non-invasive 13C-methionine breath test <br>?€?Body weight and fat distribution <br>?€?Hepatic fat content, as measured by magnetic resonance tomography<br>;Primary end point(s): The primary end point of this study will be the absolute change in the NASH activity score in a liver biopsy obtained 24 weeks after exenatide or placebo treatment.nan
|
| Sponsor/Collaborators: |
Department of Medicine I, University Hospital St. Josef-Hospital, Ruhr University Bochum
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
--
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
| Start Date: |
04/08/2009
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
19 March 2012
|
| Locations: |
Germany
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002325-37
|
