| Trial ID: | L0276 |
| Source ID: | NCT04104321
|
| Associated Drug: |
Aramchol
|
| Title: |
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
|
| Acronym: |
ARMOR
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: Aramchol|Drug: Placebo
|
| Outcome Measures: |
Open label part: Kinetics of histological outcome measures|Double Blind Part: To evaluate the effect of Aramchol compared to placebo on liver histology by assessing the following primary endpoints:|Double Blind Part: To evaluate the effect of Aramchol compared to placebo on composite long-term outcome
|
| Sponsor/Collaborators: |
Galmed Research and Development, Ltd.|Galmed Pharmaceuticals Ltd
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 3
|
| Enrollment: |
2000
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
September 23, 2019
|
| Completion Date: |
June 2027
|
| Results First Posted: |
--
|
| Last Update Posted: |
October 28, 2021
|
| Locations: |
The Public Health Trust of Miami-Dade County, Florida, dba the Jackson Health System, Miami, Florida, United States|Texas Clinical Research Institute, LLC, Arlington, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT04104321
|
