| Trial ID: | L0338 |
| Source ID: | NCT02769091
|
| Associated Drug: |
TEV-45478
|
| Title: |
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
| Acronym: |
NASH
|
| Status: |
Withdrawn
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis|Type 2 Diabetes Mellitus
|
| Interventions: |
Drug: TEV-45478|Drug: Placebo
|
| Outcome Measures: |
serum Alanine Transaminase (ALT) levels response, defined as ALT value within reference range of <35 IU/L for women and <40 IU/L for men|liver fat response, defined as a reduction of ???6% at week 24 compared to screening by the MRI-Proton Density Fat Fraction (PDFF)|Percentage of Participants with Adverse Events|percent change from baseline in ALT|percent change from baseline in Aspartate Aminotransferase (AST)|change from baseline in AST|change from baseline in ALT|Change from baseline in glycosylated hemoglobin ((HbA1c)|Change from baseline in liver fibrosis measured using transient elastography (with Fibroscan)
|
| Sponsor/Collaborators: |
Teva Branded Pharmaceutical Products R&D, Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
0
|
| 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 30, 2016
|
| Completion Date: |
February 28, 2018
|
| Results First Posted: |
--
|
| Last Update Posted: |
November 9, 2021
|
| Locations: |
--
|
| URL: |
https://ClinicalTrials.gov/show/NCT02769091
|
