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NCT02787304 · ClinicalTrials.gov registry record · Phase 2
Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Mirum Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 197
- Enrollment target
NCT02787304: Clinical Trial Phase 2 study, sponsored by Mirum Pharmaceuticals.
NCT02787304 is a Phase 2 study that was terminated before completion, run by Mirum Pharmaceuticals. The registered enrollment target is 197 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02787304, a Phase 2 study, was terminated before completion, sponsored by Mirum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 197 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the investigational treatment volixibat (SHP626) is safe, tolerable and effective in adults with nonalcoholic steatohepatitis (NASH).
Primary Outcome
Binary response indicating (yes/no) whether a subject responded at week 48 with a reduction of at least 2 points, without worsening of fibrosis, from baseline nonalcoholic fatty liver disease (NAFLD) activity score (NAS). The NAS grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and ballooning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding
Interventions
- DRUG Placebo
- DRUG SHP626
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2016-10-24 |
| Est. Completion | 2018-07-27 |
| Phase | Phase 2 |
Why NCT02787304 stopped before completion
NCT02787304 is an interventional study that assigns participants to a tested intervention. The registered 197 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 (48% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02787304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02787304 about?
NCT02787304 is a clinical study titled "Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)". The purpose of this study is to determine if the investigational treatment volixibat (SHP626) is safe, tolerable and effective in adults with nonalcoholic steatohepatitis (NASH).
What is the current status of trial NCT02787304?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 197 participants. The study started on 2016-10-24. Estimated completion is 2018-07-27.
What interventions are being tested in trial NCT02787304?
The interventions under investigation include: Placebo (DRUG), SHP626 (DRUG).
Who is sponsoring clinical trial NCT02787304?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02787304's enrollment target sits among peer trials
197 349th of 2000 higher than 1,652 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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