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NCT02287779 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
A Phase 1 study of Nonalcoholic Steatohepatitis, sponsored by Mirum Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT02287779: Completed Phase 1 study of Nonalcoholic Steatohepatitis, sponsored by Mirum Pharmaceuticals.
NCT02287779 is a Phase 1 study of Nonalcoholic Steatohepatitis that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 84 participants, below the 700-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02287779, a Phase 1 study of Nonalcoholic Steatohepatitis, has completed, sponsored by Mirum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
Primary Outcome
TEAEs were defined as events that either had a start date on or after the first dose of investigational medicinal product (IMP) or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An adverse event (AE) that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Hematology parameters included evaluation of hemoglobin, hematocrit, red blood cells, platelets, white bl
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SHP626
Study Locations (1)
Tennessee
- New Orleans Center for Clinical Research - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2015-01-19 |
| Est. Completion | 2015-06-19 |
| Phase | Phase 1 |
What the finished NCT02287779 record still lists
NCT02287779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 700-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02287779 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02287779 about?
NCT02287779 is a clinical study titled "Safety and Tolerability Study of SHP626 in Overweight and Obese Adults". This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
What is the current status of trial NCT02287779?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2015-01-19. Estimated completion is 2015-06-19.
What conditions does trial NCT02287779 study?
This clinical trial studies the following conditions: Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT02287779?
The interventions under investigation include: Placebo (DRUG), SHP626 (DRUG).
Who is sponsoring clinical trial NCT02287779?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02287779 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02287779's enrollment target sits among peer trials
84 21st of 30 higher than 9 of 30 other Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nonalcoholic Steatohepatitis 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.
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