| Trial ID: | L0191 |
| Source ID: | NCT00596934
|
| Associated Drug: |
Metreleptin
|
| Title: |
Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT00596934/results
|
| Conditions: |
Fatty Liver Disease, Nonalcoholic
|
| Interventions: |
Drug: metreleptin
|
| Outcome Measures: |
Non-alcoholic Steatohepatitis Score as Determined by Liver Histopathology at 12 Months|Body Weight at 12 Months|Liver Fat Percentage by Magnetic Resonance Imaging (MRI - Dixon Method) at 12 Months|Liver Function Test: Alanine Aminotransferase (ALT) Values at 12 Months|Liver Function Test: Aspartate Aminotransferase (AST) Values at 12 Months|Fasting Glucose Value at 12 Months|Fasting Triglycerides Value at 12 Months|Insulin Resistance: Homeostatic Model Assessment (HOMA) at 12 Months
|
| Sponsor/Collaborators: |
Elif Oral|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|University of Michigan
|
| Gender: |
Male
|
| Age: |
18 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
9
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
February 2006
|
| Completion Date: |
March 2009
|
| Results First Posted: |
December 9, 2016
|
| Last Update Posted: |
November 24, 2017
|
| Locations: |
University of Michigan, Ann Arbor, Michigan, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT00596934
|
