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NCT01414881 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects
A Phase 1 study, sponsored by Kastle Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01414881: Completed Phase 1 study, sponsored by Kastle Therapeutics.
NCT01414881 is a Phase 1 study that has completed, run by Kastle Therapeutics. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01414881, a Phase 1 study, has completed, sponsored by Kastle Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The primary objective of this Phase I exploratory study is to determine the effects of mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period, a 1-week Run-in Period to establish a stable diet, an approximate 11-week Treatment Period with Placebo or Mipomersen, and a 25-week Post-Treatment Follow-up Period. The total duration of any given subject's participation will be approximately 40 weeks.
Interventions
- DRUG Placebo
- DRUG mipomersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT01414881 record still lists
NCT01414881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01414881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01414881 about?
NCT01414881 is a clinical study titled "Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects". The primary objective of this Phase I exploratory study is to determine the effects of mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period, a 1-week Run-in Period to establis...
What is the current status of trial NCT01414881?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01414881?
The interventions under investigation include: Placebo (DRUG), mipomersen (DRUG).
Who is sponsoring clinical trial NCT01414881?
This trial is sponsored by Kastle Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01414881's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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