| Trial ID: | L0481 |
| Source ID: | NCT03812029
|
| Associated Drug: |
EYP001a
|
| Title: |
A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis
|
| Interventions: |
Drug: EYP001a;Other: Placebo
|
| Outcome Measures: |
Change in absolute liver fat content as measured by MRI from Baseline to Week 12;Safety profile of EYP001a - Frequency of adverse events% patients with relative reduction in liver fat =30% using MRI;relative reduction in liver fat;Percent change in liver imaging-derived mean iron-corrected T1;Liver inflammation markers
|
| Sponsor/Collaborators: |
Enyo Pharma
|
| Gender: |
All
|
| Age: |
18 Years75 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
120
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
| Start Date: |
17/01/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
27 September 2021
|
| Locations: |
United States;Belgium;France;Puerto Rico;United Kingdom;Belgium;France;Puerto Rico;United Kingdom;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03812029
|
