Clinical Trial Details
| Trial ID: | L0220 |
| Source ID: | NCT02442687 |
| Associated Drug: | JKB-121 |
| Title: | JKB-121 for the Treatment of Nonalcoholic Steatohepatitis |
| Acronym: | -- |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT02442687/results |
| Conditions: | Nonalcoholic Steatohepatitis |
| Interventions: | Drug: JKB-121: 5 mg twice daily|Drug: JKB-121: 10 mg twice daily|Drug: Placebo |
| Outcome Measures: | Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population)|Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population)|Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population)|Analysis of ALT Change From Baseline to Week 12 (Per Protocol Population)|Time to Remission (in Weeks)|Change in BMI (Body Mass Index)|Change in Hemoglobin A1C|Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Percent Change in Cholesterol|Percent Change in Triglycerides|Percent Change in Low Density Lipoprotein (LDL) Cholesterol|Percent Change in High Density Lipoprotein (HDL)|Mean Serum Aspartate Aminotransferase (AST)|Mean Serum Alanine Aminotransferase (ALT)|Mean Serum Gamma-glutamyl Transpeptidase (GGT)|Number of Subjects With ALT in Normal Range at Week 24|Maximum Observed Concentrations (Cmax)|Minimum Observed Concentration (Cmin)|Area Under Concentration-time (AUC)|Half-life |
| Sponsor/Collaborators: | Manal Abdelmalek|Duke University |
| Gender: | All |
| Age: | 18 Years and older ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 65 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | August 1, 2015 |
| Completion Date: | September 24, 2017 |
| Results First Posted: | January 7, 2019 |
| Last Update Posted: | January 7, 2019 |
| Locations: | Digestive Disease Specialists of the Southeast, Dothan, Alabama, United States|Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States|Digestive Associates, Las Vegas, Nevada, United States|Duke University, Durham, North Carolina, United States|Digestive Disease Specialists, Cincinnati, Ohio, United States|Brook Army Medical Center, Houston, Texas, United States|University of Virginia Health Systems, Charlottesville, Virginia, United States|Medical College of Virginia, Richmond, Virginia, United States |
| URL: | https://ClinicalTrials.gov/show/NCT02442687 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D192 | JKB-121 | Chemical drug | DB06230 | TLR4 antagonist | Anti-inflammatory | Under clinical trials | Details |
| D010 | Amoxicillin | Chemical drug | DB01060 | -- | -- | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D182 | Insulin | Biological drug | DB00030 | INSR agonist; CPE modulator&product of | -- | Under clinical trials | Details |
| D199 | L-alanine | Chemical drug | DB00160 | KYNU | -- | Failed in clinical trials | Details |
| D223 | Metabolic Cofactor Supplementation | Supplement | -- | -- | -- | Under clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |