| Trial ID: | L0677 |
| Source ID: | EUCTR2009-016761-29-GB
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| Associated Drug: |
Liraglutide
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| Title: |
A 48-WEEK PHASE II, RANDOMISED, DOUBLE BLINDED PLACEBO CONTROLLED, PARALLEL-GROUP, MULTI-CENTRE TRIAL ON LIRAGLUTIDE?€?S SAFETY, EFFICACY AND ACTION ON LIVER HISTOLOGY AND METABOLISM IN OVERWEIGHT PATIENTS WITH NON-ALCOHOLIC STEATOHEPATITIS, WITH OR WITHO
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-alcoholic steatohepatits (NASH) <br>
MedDRA version: 14.0
Level: PT
Classification code 10012601
Term: Diabetes mellitus
System Organ Class: 10027433 - Metabolism and nutr
|
| Interventions: |
<br> Trade Name: Victoza 6mg/ml<br> Product Name: Victoza (Liraglutide)<br> Pharmaceutical Form: Solution for injection<br> INN or Proposed INN: LIRAGLUTIDE<br> Concentration unit:
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| Outcome Measures: |
Main Objective: To investigate the safety and efficacy of 48 weeks treatment with once-daily injections of liraglutide in damaged liver tissue in overweight patients with non-alcoholic steatohepatitis [NASH] (i.e. the more severe, inflammatory form of fatty liver disease). To investigate whether the effect of liraglutide on NASH warrants further investigation.;Secondary Objective: To investigate whether 48 weeks treatment with once-daily injections of liraglutide in overweight patients with non-alcoholic steatohepatitis effects the following, whilst maintaining the safety of the trial particpants: 1. reducing fat accumulation in the liver 2. reducing liver inflammation and scarring 3. reducing body weight, blood pressure, cholesterol and sugar levels (all of which are risk factors for heart disease, diabetes and increased risk of premature death) 4. improving the livers control of dangerous fats and high sugar levels in response to the hormone, insulin. 5. improving the patients nutrional intake and quality of life (analysed in questionnaire format);Primary end point(s): The primary objective is to investigate whether 48 weeks treatment with once-daily injections of liraglutide results in an improvement in liver histology in overweight patients with NASH. Both of the following criteria MUST be met in order to report an improvement in liver histology after treatment; ?€? Disappearance of NASH (i.e. disappearance of hepatocyte ballooning) ?€? No worsening in fibrosis stage (as defined by Kleiner et al, 2005)nan
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| Sponsor/Collaborators: |
University of Birmingham
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
25
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
<br> Controlled: yes<br> Randomised: yes<br> Open: no<br> Single blind: no<br> Double blind: yes<br> Parallel group: yes<br> Cross over: no<br>
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| Start Date: |
16/04/2010
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
10 December 2019
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| Locations: |
United Kingdom
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016761-29
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