Clinical Trial Details
| Trial ID: | L0115 |
| Source ID: | NCT02546609 |
| Associated Drug: | NS-0200 |
| Title: | The Effect Of NS-0200 Versus Placebo On Hepatic Fat Content In Patients With Non Alcoholic Fatty Liver Disease |
| Acronym: | -- |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT02546609/results |
| Conditions: | NAFLD |
| Interventions: | Drug: Leu-Met-Sil 0.5|Drug: Leu-Met-Sil 1.0|Drug: Placebo |
| Outcome Measures: | Change in Hepatic Fat|Change in Serum AlanineAaminotransferase (ALT) Levels|Change in Circulating Cytokeratin 18 Fragments (M30)|Change in Heamoglobin A1c (HbA1c)|Change in Fasting Glucose|Change in Insulin|Change in Blood Lipids (Cholesterol)|Change in Blood Lipids (High Density Lipoprotein:HDL)|Change in Low Density Lipoproteins (LDL)|Change in Triglycerides|Change in C-reactive Protein|Change in Insulin Sensitivity (HOMA-IR) |
| Sponsor/Collaborators: | NuSirt Biopharma |
| Gender: | All |
| Age: | 18 Years to 75 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 91 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | November 19, 2015 |
| Completion Date: | January 31, 2017 |
| Results First Posted: | May 2, 2018 |
| Last Update Posted: | May 2, 2018 |
| Locations: | Catalina Research Institute, Chino, California, United States|University of California San Diego, San Diego, California, United States|Rocky Mountain Research, Wheat Ridge, Colorado, United States|Atlanta Gastroenterology Associates, Atlanta, Georgia, United States|GI Specialists of Georgia, Marietta, Georgia, United States|Northwestern University, Chicago, Illinois, United States|Indiana University, Indianapolis, Indiana, United States|University of North Carolina Chapel Hill, Chapel Hill, North Carolina, United States|Sterling Research, Cincinnati, Ohio, United States|Premier Clinical Research, Clarksville, Tennessee, United States|Gastro One, Germantown, Tennessee, United States|Quality Medical Research, Nashville, Tennessee, United States|Virginia Commonwealth University, Richmond, Virginia, United States |
| URL: | https://ClinicalTrials.gov/show/NCT02546609 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D499 | NS-0200 | Combinatory | -- | -- | -- | 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 |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |