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NCT02475317 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion
A Phase 1 study, sponsored by Mirum Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT02475317: Completed Phase 1 study, sponsored by Mirum Pharmaceuticals.
NCT02475317 is a Phase 1 study that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02475317, a Phase 1 study, has completed, sponsored by Mirum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the relative potency of multiple oral doses of LUM001 and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight and obese adult subjects. This study is designed to address the relative potency question for the first time in the same.
Primary Outcome
Fecal bile acid excretion was determined by the concentration of total bile acids in stool samples over each 24-hour collection window during the lead-in and treatment periods.
Interventions
- DRUG Placebo
- DRUG Volixibat
- DRUG Maralixibat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2015-06-01 |
| Est. Completion | 2015-12-01 |
| Phase | Phase 1 |
What the finished NCT02475317 record still lists
NCT02475317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02475317 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02475317 about?
NCT02475317 is a clinical study titled "Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion". The purpose of this study is to assess the relative potency of multiple oral doses of LUM001 and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight and obese adult subjects. This study is designed to address the relative potency question for the first time in the s...
What is the current status of trial NCT02475317?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2015-06-01. Estimated completion is 2015-12-01.
What interventions are being tested in trial NCT02475317?
The interventions under investigation include: Placebo (DRUG), Volixibat (DRUG), Maralixibat (DRUG).
Who is sponsoring clinical trial NCT02475317?
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 NCT02475317's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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