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Clinical Trial Details

Trial ID: L1882
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Status: WITHDRAWN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:
Conditions: Nonalcoholic Steatohepatitis|Type 2 Diabetes Mellitus
Interventions: DRUG: TEV-45478|DRUG: Placebo
Outcome Measures: Primary: 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, Week 24|liver fat response, defined as a reduction of ≥6% at week 24 compared to screening by the MRI-Proton Density Fat Fraction (PDFF), Week 24|Percentage of Participants with Adverse Events, 24 weeks | Secondary: percent change from baseline in ALT, Baseline, Week 24|percent change from baseline in ALT, Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 (or early withdrawal)|percent change from baseline in Aspartate Aminotransferase (AST), Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 (or early withdrawal)|change from baseline in AST, Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 (or early withdrawal)|change from baseline in ALT, Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 (or early withdrawal)|Change from baseline in glycosylated hemoglobin ((HbA1c), Baseline, Weeks 4, 12, and 24 (or early withdrawal)|Change from baseline in liver fibrosis measured using transient elastography (with Fibroscan), Baseline, Week 24 (or early withdrawal)
Sponsor/Collaborators: Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-09-30
Completion Date: 2018-02-28
Results First Posted:
Last Update Posted: 2021-11-09
Locations:
URL: https://clinicaltrials.gov/show/NCT02769091