A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
Primary Objectives 1. To evaluate the effect of seladelpar on hepatic fat fraction, as assessed by magnetic resonance imaging‐proton density fat fraction (MRI‐PDFF) at Week 12 in the DB phase 2. To evaluate the safety and tolerability of seladelpar in the DB and OLE phases Secondary Objectives 1. To evaluate the effect of seladelpar on MRI‐ PDFF at Week 26 and Week 52 in the DB phase 2. To evaluate the effect of seladelpar on histological improvement of nonalcoholic fatty liver disease activity score (NAS) at Week 52 in the DB phase 3. To evaluate the effect of seladelpar on histological improvement of fibrosis at Week 52 in the DB phase 4. To evaluate the effect of seladelpar on metabolic biochemical markers and biochemical markers of inflammation in the DB and OLE phases
Epistemonikos ID: d33f9f24748b9359ccfc6e94bda8946f76d61d9d
First added on: May 21, 2024