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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 20 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01959971
The ClinicalTrials.gov registry entry for NCT01959971 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01959971 reports 0 study locations.
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.
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