| Trial ID: | L0479 |
| Source ID: | EUCTR2016-002045-36-GB
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| Associated Drug: |
Liraglutide
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| Title: |
Lifestyle induced weight loss and Liraglutide in the treatment of non-alcoholic steatohepatitis (NASH)
- Lifestyle and Liraglutide in NASH
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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 steatohepatitis (NASH);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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| Interventions: |
<br>Trade Name: Victoza<br>Product Name: Victoza<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: Liraglutide<br>CAS Number: 204656-20-2<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentra
|
| Outcome Measures: |
Main Objective: To determine if treatment with Liraglutide improves liver fat and inflammation (non-alcoholic steatohepatitis, NASH), more than matched weight loss alone;Secondary Objective: Investigate changes in:<br>1. the rate of hepatic de-novo lipogenesis (new fat generation and deposition in the liver)<br>2. circulating liver transaminases (liver function markers in the blood)<br>3. liver and peripheral insulin sensitivity and glucose disposal (metabolism)<br>4. adipose (fat) tissue insulin sensitivity <br>5. whole body fat oxidation<br>6. weight and BMI<br>7. body fat and muscle composition<br>;Primary end point(s): Hepatic fat and inflammation measured using multi-parametric MR imaging (abdominal MRI);Timepoint(s) of evaluation of this end point: 12 and 24 weeks.Secondary end point(s): Change in rate of hepatic de-novo lipogenesis.<br>Change in circulating liver transaminases.<br>Change in hepatic and peripheral insulin sensitivity and glucose disposal.<br>Change in adipose tissue insulin sensitivity.<br>Change in whole body oxidation.<br>Change in weight.<br>Change in body composition.<br>Change in urinary markers of liver disease.<br>Change in faecal markers of liver disease.;Timepoint(s) of evaluation of this end point: 12 and 24 weeks
|
| Sponsor/Collaborators: |
University of Oxford, Clinical Trials and Research Governance
|
| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
50
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: <br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the co
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| Start Date: |
05/02/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
20 July 2020
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| Locations: |
United Kingdom
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002045-36
|
