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Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol

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ClinicalTrials.gov Identifier: NCT01959971
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: alirocumab Drug: Placebo Phase 1

Detailed Description:
Total duration of the study per subject is 26 weeks, including a screening period of ≤ 4 weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a follow up period of 8 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Crossover Assignment
Intervention Model Description: Single-sequence crossover
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Phase 1 Study of the Effects of Subcutaneous Doses of Alirocumab on Lipid and Lipoprotein Metabolism in Adults With Mildly Elevated LDL-Cholesterol
Study Start Date : December 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: Placebo - Alirocumab
Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks
Drug: alirocumab

Pharmaceutical form:Solution for injection

Route of administration: Subcutaneous

Other Names:
  • SAR236553
  • REGN727
  • Praluent

Drug: Placebo

Pharmaceutical form:Solution for injection

Route of administration: Subcutaneous





Primary Outcome Measures :
  1. Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment [ Time Frame: baseline and at 12 days after last dose of alirocumab ]

Secondary Outcome Measures :
  1. Change in lipids turnover parameters measured in isolated Very Low Density Lipoproteins (VLDL), Intermediate Density Lipoproteins (IDL), Low Density Lipoproteins (LDL) and High Density Lipoproteins (HDL) [ Time Frame: baseline and at 12 days after last dose of alirocumab ]
  2. Change in post-heparin hepatic lipase and lipoprotein lipase activities [ Time Frame: baseline and at 2 days after last dose of alirocumab ]
  3. Change in lipids and apolipoproteins in plasma lipids panel [ Time Frame: baseline and at 2 days and at 11 days after last dose of alirocumab ]
  4. Assessment of Lipoprotein particle size profiles [ Time Frame: baseline and at 2 days and at 11 days after last dose of alirocumab ]
  5. Assessment of serum concentrations of PCSK9 [ Time Frame: baseline and up to 2 weeks after last dose of alirocumab ]
  6. Assessment of safety parameters (clinical laboratory, ECG, vital signs) [ Time Frame: up to 10 weeks after last dose of alirocumab ]
  7. Assessment of the serum concentration of alirocumab [ Time Frame: baseline and up to 2 weeks after last dose of alirocumab ]
  8. Assessment of the serum concentration of anti-alirocumab antibodies [ Time Frame: baseline and up to 10 weeks after last dose of alirocumab ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Generally healthy; LDL-C level in serum or plasma ≥ 100 mg/dL and < 190 mg/dL at Screening.

Exclusion criteria:

  • LDL-C ≥ 160 mg/dL at Screening if more than 2 major Coronary Heart Disease risk factors, as defined in National Cholesterol Education Program guidelines.
  • Receiving treatment of any kind for hyperlipidemia within 6 weeks of enrollment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959971


Locations
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United States, New York
Investigational Site Number 840001
New York, New York, United States, 10032
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications of Results:
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01959971     History of Changes
Other Study ID Numbers: PDY13670
U1111-1141-4567 ( Other Identifier: UTN )
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs