| Trial ID: | L4321 |
| Source ID: | NCT01237119
|
| Associated Drug: |
Liraglutide
|
| Title: |
Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis
|
| Acronym: |
LEAN
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
DRUG: Liraglutide|OTHER: Liraglutide-placebo
|
| Outcome Measures: |
Primary: Liver Histological improvement, 48 weeks | Secondary: NAFLD Activity Score, Also including: Fibrosis panel, Liver Function Tests (LFTs), cytokeratin-18 (CK-18) Glycaemic control, Fibroscan, Quality of life, 48 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Birmingham | Collaborators: Wellcome Trust|Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
52
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-08
|
| Completion Date: |
2014-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-03-23
|
| Locations: |
NIHR BRU Centre for liver research, Queens Elizabeth University Hospital Birmingham, Birmingham, West Midlands, B152TT, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT01237119
|
