| Trial ID: | L0360 |
| Source ID: | NCT03508687
|
| Associated Drug: |
Gemcabene
|
| Title: |
Study of Gemcabene in Adults With FPLD
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT03508687/results
|
| Conditions: |
Familial Partial Lipodystrophy|Hypertriglyceridemia|Fatty Liver|NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: 300mg Gemcabene|Drug: 600mg Gemcabene
|
| Outcome Measures: |
Change in Fasting Serum Triglyceride (at 12 Weeks)|Change in Fasting Serum Triglycerides (Through 24 Weeks)|Percent Change in Fasting Serum Triglycerides (Through 24 Weeks)|Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF)|Percent Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF)|Change in Liver Fibrosis|Percent Change in Liver Fibrosis|Change in NAS (Non-alcoholic Steatohepatitis)|Percent Change in NAS (Non-alcoholic Steatohepatitis)|Change in Cholesterol|Percent Change in Cholesterol|Change in Apolipoprotein|Percent Change in Apolipoprotein|Change in High-Sensitivity C-Reactive Protein (hsCRP)|Percent Change in High-Sensitivity C-Reactive Protein (hsCRP)|Change in Alanine Aminotransferase (ALT)|Percent Change in Alanine Aminotransferase (ALT)|Change in Aspartate Aminotransferase (AST)|Percent Change in Aspartate Aminotransferase (AST)
|
| Sponsor/Collaborators: |
Elif Oral|University of Michigan
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 1/Phase 2
|
| Enrollment: |
5
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
March 13, 2018
|
| Completion Date: |
July 31, 2019
|
| Results First Posted: |
August 17, 2020
|
| Last Update Posted: |
August 17, 2020
|
| Locations: |
University of Michigan, Ann Arbor, Michigan, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT03508687
|
