| Trial ID: | L0165 |
| Source ID: | NCT05117489
|
| Associated Drug: |
Miricorilant
|
| Title: |
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: Miricorilant Dose Escalation|Drug: Miricorilant 150 mg|Drug: Miricorilant 300 mg|Drug: Miricorilant 450 mg
|
| Outcome Measures: |
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.|Change from Baseline in aspartate aminotransferase (AST).|Change from Baseline in alanine aminotransferase (ALT).|Change from Baseline in gamma-glutamyl transferase (GGT).|Change from baseline in enhanced liver fibrosis score (ELF).
|
| Sponsor/Collaborators: |
Corcept Therapeutics
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
26
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
November 2021
|
| Completion Date: |
October 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
November 11, 2021
|
| Locations: |
Site 207, Chandler, Arizona, United States|Site 209, Tucson, Arizona, United States|Site 210, Sarasota, Florida, United States|Site 211, Austin, Texas, United States|Site 213, Edinburg, Texas, United States|Site 212, San Antonio, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT05117489
|
