| Trial ID: | L0273 |
| Source ID: | NCT05118360
|
| Associated Drug: |
ASC41
|
| Title: |
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH
|
| Acronym: |
--
|
| Status: |
Not yet recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: ASC41 2 mg|Drug: ASC41 4 mg|Drug: Placebo
|
| Outcome Measures: |
Percent of ASC41 subjects compared to placebo with histological reduction in NAS ???2 points that results from reduction of inflammation or ballooning and no worsening fibrosis assessed by histopathological reading of liver biopsy at Week 52|Safety and tolerability of ASC41 evaluated by incidence of treatment emergent adverse events (TEAEs) in ASC41 treated subjects compared to placebo|Change in hepatic fat fraction based on MRI-PDFF measurements in ASC41 treated subjects compared to placebo.|Resolution of NASH on overall histopathological reading of liver biopsy specimen taken at Week 52 compared to baseline in ASC41 treated subjects compared to placebo treated subjects
|
| Sponsor/Collaborators: |
Gannex Pharma Co., Ltd.
|
| Gender: |
All
|
| Age: |
18 Years to 80 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
180
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
March 30, 2022
|
| Completion Date: |
January 9, 2024
|
| Results First Posted: |
--
|
| Last Update Posted: |
December 28, 2021
|
| Locations: |
--
|
| URL: |
https://ClinicalTrials.gov/show/NCT05118360
|
