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NCT03551522 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 181
- Enrollment target
NCT03551522: Clinical Trial Phase 2 study, sponsored by Gilead Sciences.
NCT03551522 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 181 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03551522, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 181 participants
- Enrollment target
Study 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
Primary Outcome
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 double-blind (DB) phase. MRI-PDFF Relative (Percent) Change From Baseline to Week 12 - ANCOVA - mITT Population MRI-PDFF exam was used to quantify the hepatic proton density fat fraction noninvasively. The fat fraction is the proportion of mobile protons in liver tissue attributable to fat and thus, is a noninvasive magnetic resonance-base
Interventions
- DRUG Placebos
- DRUG Seladelpar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2020-08-10 |
| Phase | Phase 2 |
Why NCT03551522 stopped before completion
NCT03551522 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03551522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03551522 about?
NCT03551522 is a clinical study titled "A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)". 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
What is the current status of trial NCT03551522?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 181 participants. The study started on 2018-04-30. Estimated completion is 2020-08-10.
What interventions are being tested in trial NCT03551522?
The interventions under investigation include: Placebos (DRUG), Seladelpar (DRUG).
Who is sponsoring clinical trial NCT03551522?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03551522's enrollment target sits among peer trials
181 365th of 2000 higher than 1,636 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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