Clinical Trial Details
| Trial ID: | L0201 |
| Source ID: | NCT03863574 |
| Associated Drug: | Saroglitazar Magnesium |
| Title: | Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis |
| Acronym: | EVIDENCES VI |
| Status: | Completed |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Non Alcoholic Steatohepatitis |
| Interventions: | Drug: Saroglitazar Magnesium 2mg|Drug: Saroglitazar Magnesium 4mg|Drug: Placebos |
| Outcome Measures: | NAS Score (NAFLD Activity Score)|To evaluate the percentage of responders in the treatment groups.|Percentage of responders defined by the disappearance of steatohepatitis.|Changes in the stage of steatosis, lobular inflammation and ballooning.|Changes in the stage of fibrosis.|Changes in the liver function tests.|Changes in the lipid profile.|Changes in the glycemic control and insulin resistance.|To assess incidence of Adverse Events of Saroglitazar Magnesium 2 mg and 4 mg in patients with non-alcoholic steatohepatitis. |
| Sponsor/Collaborators: | Zydus Therapeutics Inc. |
| Gender: | All |
| Age: | 18 Years to 75 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 16 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | June 12, 2019 |
| Completion Date: | October 30, 2020 |
| Results First Posted: | -- |
| Last Update Posted: | December 14, 2020 |
| Locations: | Southern Therapy and Advanced Research (STAR) LLC, Jackson, Mississippi, United States|Gastro One, Germantown, Tennessee, United States|Digestive Health Research, Hermitage, Tennessee, United States|American Research Corporation, San Antonio, Texas, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, United States|Virginia Commonwealth University, Richmond, Virginia, United States |
| URL: | https://ClinicalTrials.gov/show/NCT03863574 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D412 | Saroglitazar Magnesium | Chemical drug | -- | -- | -- | Under clinical trials | Details |
| D182 | Insulin | Biological drug | DB00030 | INSR agonist; CPE modulator&product of | -- | Under clinical trials | Details |
| D545 | Pig placenta extract | Biological extract | -- | -- | -- | Under clinical trials | Details |