Clinical Trial Details
| Trial ID: | L0166 |
| Source ID: | NCT03823703 |
| Associated Drug: | Miricorilant |
| Title: | Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH) |
| Acronym: | -- |
| Status: | Terminated |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Nonalcoholic Steatohepatitis (NASH) |
| Interventions: | Drug: Miricorilant|Drug: Placebo |
| Outcome Measures: | Relative change from Baseline in LFC (liver fat content) assessed by MRI-PDFF.|Proportion of patients achieving a relative reduction in LFC of ???30% by MRI-PDFF|Change from Baseline in propeptide of type III collagen (pro-C3)|Change from Baseline in enhanced liver fibrosis (ELF) score and its components (hyaluronic acid, tissue inhibitor of metalloproteinases-1 [TIMP-1], type III procollagen [PIIINP])|Change from Baseline in aspartate aminotransferase (AST)|Change from Baseline in alanine aminotransferase (ALT) |
| Sponsor/Collaborators: | Corcept Therapeutics |
| Gender: | All |
| Age: | 18 Years to 75 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 12 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | November 4, 2020 |
| Completion Date: | April 5, 2021 |
| Results First Posted: | -- |
| Last Update Posted: | October 6, 2021 |
| Locations: | Site 207, Chandler, Arizona, United States|Site 208, Glendale, Arizona, United States|Site 209, Tucson, Arizona, United States|Site 227, Los Angeles, California, United States|Site 214, Panorama City, California, United States|Site 233, Santa Ana, California, United States|Site 234, Port Orange, Florida, United States|Site 210, Sarasota, Florida, United States|Site 228, Kansas City, Missouri, United States|Site 232, East Syracuse, New York, United States|Site 211, Austin, Texas, United States|Site 213, Edinburg, Texas, United States|Site 215, Edinburg, Texas, United States|Site 212, San Antonio, Texas, United States|Site 226, Seattle, Washington, United States |
| URL: | https://ClinicalTrials.gov/show/NCT03823703 |
