At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
Saroglitazardrug
Likely dose
Saroglitazar 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2A, Single Center, Open-label, Single-arm, 24-week Study to Evaluate the Safety, Tolerability and Efficacy of Saroglitazar Magnesium 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (EVIDENCES VIII)
In Brief
A Phase 2 clinical trial evaluating Saroglitazar for Liver Transplant; Complications and NAFLD. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplant; Complications, NAFLD
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartFeb 2019
Primary CompletionDec 2021
TodayJul 2026
First PostedAug 21, 2018
Enrollment StartFeb 25, 2019
Primary CompletionDec 13, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.9 years ago
Interventions
Saroglitazardrug
Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food