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NCT01959971 · ClinicalTrials.gov registry record · Phase 1
Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01959971: Completed Phase 1 study, sponsored by Sanofi.
NCT01959971 is a Phase 1 study that has completed, run by Sanofi. 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
NCT01959971, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Primary Objective: To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C). Secondary Objectives: To assess the effects of SC doses of alirocumab on: * Various parameters of the metabolism and turnover in plasma of different lipoproteins * Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB, lipoprotein(a) (Lp(a)) * Lipoprotein particle size profile * PCSK9 (free and total) concentrations in serum To assess safety and tolerability of alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum alirocumab concentrations.
Interventions
- DRUG Placebo
- DRUG alirocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT01959971 record still lists
NCT01959971 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.
NCT01959971 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01959971 about?
NCT01959971 is a clinical study titled "Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol". Primary Objective: To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C). Secondary Objectives: To assess th...
What is the current status of trial NCT01959971?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2013-12. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01959971?
The interventions under investigation include: Placebo (DRUG), alirocumab (DRUG).
Who is sponsoring clinical trial NCT01959971?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01959971'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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