| Trial ID: | L0092 |
| Source ID: | NCT03436420
|
| Associated Drug: |
Gemcabene
|
| Title: |
Gemcabene for the Treatment of Pediatric NAFLD
|
| Acronym: |
--
|
| Status: |
Terminated
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT03436420/results
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Gemcabene
|
| Outcome Measures: |
Percent Change in Alanine Aminotransferase (ALT)|Absolute Change in ALT|Percent Change in ALT Between Study Visits|Absolute Change in Hepatic Steatosis|Absolute Change in Pancreatic Fat|Absolute Change in Aspartate Aminotransferase (AST)|Change in Fasting Insulin|Change in Fasting Glucose|Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score|Absolute Change in Gamma-glutamyltransferase (GGT)|Absolute Change in Total Cholesterol|Absolute Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)|Absolute Change in High-density Lipoprotein (HDL) Cholesterol|Absolute Change in Very-low-density Lipoprotein Cholesterol (VLDL-C)|Absolute Change in Low-density Lipoprotein (LDL) Cholesterol|Absolute Change in Triglycerides (TG)|Absolute Change in Apolipoprotein A-1 (ApoA-1)|Absolute Change in Apolipoprotein B (ApoB)|Absolute Change in Apolipoprotein C-II (ApoC-II)|Absolute Change in Apolipoprotein E (ApoE)|Absolute Change in Apolipoprotein CIII (ApoCIII)|Absolute Change in High Sensitivity C-Reactive Protein (hsCRP)|Change in Interleukin 1 Beta (IL-1B)|Change in Interleukin 6 (IL-6)|Change in Procollagen III|Change in Particle Size of VLDL|Change in Particle Size of HDL|Change in Particle Size of LDL|Change in Particle Size of Chylomicrons|Change in Rate of de Novo Lipogenesis (DNL)|Absolute Change in Abdominal Visceral Fat|Absolute Change in Abdominal Subcutaneous Fat|Change in Liver Inflammation and Fibrosis (LIF) Score|Absolute Change in Height|Absolute Change in Weight|Absolute Change in Body Mass Index (BMI)|Absolute Change in Waist Circumference|Pill Count
|
| Sponsor/Collaborators: |
Emory University|Gemphire Therapeutics
|
| Gender: |
All
|
| Age: |
12 Years to 17 Years ?? (Child)
|
| Phases: |
Phase 2
|
| Enrollment: |
6
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
March 29, 2018
|
| Completion Date: |
August 27, 2019
|
| Results First Posted: |
November 12, 2020
|
| Last Update Posted: |
December 31, 2020
|
| Locations: |
Children's Healthcare of Atlanta / Emory University, Atlanta, Georgia, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT03436420
|
