Clinical Trial Details
| Trial ID: | L0043 |
| Source ID: | NCT03061721 |
| Associated Drug: | Saroglitazar |
| Title: | Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis |
| Acronym: | EVIDENCES IV |
| Status: | Completed |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Non-Alcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis |
| Interventions: | Drug: Saroglitazar magnesium 1 mg|Drug: Saroglitazar magnesium 2 mg|Drug: Saroglitazar magnesium 4 mg|Drug: Placebos |
| Outcome Measures: | Percentage change from baseline in serum ALT levels at Week 16|Change in liver fat content as measured by magnetic resonance imaging-derived proton density-fat fraction (MRI-PDFF)|Proportion of patients with sustain decrease in serum ALT levels|Changes in cytokeratin-18|Changes in enhanced liver fibrosis|Change in aspartate aminotransferase-to-platelet ratio index|Pharmacokinetics of Saroglitazar Magnesium: maximum plasma concentration (Cmax)|Time to reach maximum plasma concentration (Tmax)|Terminal half life (t1/2)|Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)|Area under the curve from the time of dosing to the infinity (AUC 0-inf)|Elimination rate constant (??z)|Apparent volume of distribution (Vd/F)|Apparent clearance (CL/F)|Change in quality of life assessed by the Short-Form 36 Health Survey|Safety and tolerability of Saroglitazar Magnesium |
| Sponsor/Collaborators: | Zydus Therapeutics Inc. |
| Gender: | All |
| Age: | 18 Years to 75 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 106 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | April 6, 2017 |
| Completion Date: | December 15, 2020 |
| Results First Posted: | -- |
| Last Update Posted: | April 23, 2021 |
| Locations: | Precision Research, Chula Vista, California, United States|Cedars-Sinai Medical Center, Los Angeles, California, United States|Catalina Research Institute, Montclair, California, United States|California liver research institute, Pasadena, California, United States|Precision Research, San Diego, California, United States|Medical Associates Research Group, San Diego, California, United States|University of Florida, Gainesville, Florida, United States|Schiff Center for Liver Diseases/University of Miami, Miami, Florida, United States|Avail Clinical Research, Orange City, Florida, United States|Indiana University, Indianapolis, Indiana, United States|Mercy Medical Center, Baltimore, Maryland, United States|University of Michigan, Ann Arbor, Michigan, United States|Henry Ford Hospital, Detroit, Michigan, United States|Awasty Research Network, LLC, Marion, Ohio, United States|Einstein Medical Center, Philadelphia, Pennsylvania, United States|Gastro One, Germantown, Tennessee, United States|AIG Research, Hermitage, Tennessee, United States|Liver Consultants, Dallas, Texas, United States|The Liver Institute, San Antonio, Texas, United States|Swedish Medical Center, Seattle, Washington, United States |
| URL: | https://ClinicalTrials.gov/show/NCT03061721 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D321 | Saroglitazar | Chemical drug | DB13115 | PPARA agonist; PPARG agonist | Antidiabetic drug | Approved in India | 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 |
| D223 | Metabolic Cofactor Supplementation | Supplement | -- | -- | -- | Under clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |
| D412 | Saroglitazar Magnesium | Chemical drug | -- | -- | -- | Under clinical trials | Details |