NCT03551522

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

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2, Double-Blind (DB), Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic Steatohepatitis (NASH) OLE phase was not analyzed due to the early termination of the study

Detailed description

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

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Seladelpar	10 mg, 20 mg, or 50 mg
DRUG	Placebos	Matching placebo Capsule

Timeline

• Start date: 2018-04-30
• Primary completion: 2019-05-08
• Completion: 2020-08-10
• First posted: 2018-06-11
• Last updated: 2022-09-15
• Results posted: 2022-07-05

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study