| Trial ID: | L0271 |
| Source ID: | NCT04342793
|
| Associated Drug: |
ALS-L1023
|
| Title: |
A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Placebo oral tablet|Drug: ALS-L1023 1,200mg|Drug: ALS-L1023 1,800mg
|
| Outcome Measures: |
Change in liver fat percentage measured by MRI-PDFF|Change in liver fibrosis measured by MRE|Change in visceral fat area measured by MRI|Changes in serum concentrations of ALT and AST|Change in serum concentration of Pro-C3|Change in serum concentration of CK-18|Change in insulin sensitivity determined by HOMA-IR|Change in serum concentration of Leptin|Changes in serum concentrations of TG and TC|Change of NAFLD fibrosis score(NFS)|Change in serum concentration of Ghrelin|Change in serum concentration of Adiponection
|
| Sponsor/Collaborators: |
AngioLab, Inc.
|
| Gender: |
All
|
| Age: |
19 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
60
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
December 4, 2019
|
| Completion Date: |
September 30, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
January 13, 2021
|
| Locations: |
Hanyang University Seoul Hospital, Seoul, Korea, Republic of
|
| URL: |
https://ClinicalTrials.gov/show/NCT04342793
|
