| Trial ID: | L0108 |
| Source ID: | NCT01679197
|
| Associated Drug: |
Metreleptin
|
| Title: |
Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT01679197/results
|
| Conditions: |
Fatty Liver Disease, Nonalcoholic|Nonalcoholic Steatohepatitis|Lipodystrophy
|
| Interventions: |
Drug: Metreleptin
|
| Outcome Measures: |
Liver Histopathology|Liver Fat by MRI and MR Spectroscopy|Liver Function Tests|Fasting Lipids|Fasting Glucose|Body Weight
|
| Sponsor/Collaborators: |
University of Michigan|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
All
|
| Age: |
5 Years and older ?? (Child, Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
23
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
October 8, 2012
|
| Completion Date: |
July 13, 2016
|
| Results First Posted: |
June 14, 2017
|
| Last Update Posted: |
June 14, 2017
|
| Locations: |
University of Michigan, Ann Arbor, Michigan, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT01679197
|