NCT01959971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1.4 years

First QC Date

October 7, 2013

Last Update Submit

April 28, 2017

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment

    baseline and at 12 days after last dose of alirocumab

Secondary Outcomes (8)

  • 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)

    baseline and at 12 days after last dose of alirocumab

  • Change in post-heparin hepatic lipase and lipoprotein lipase activities

    baseline and at 2 days after last dose of alirocumab

  • Change in lipids and apolipoproteins in plasma lipids panel

    baseline and at 2 days and at 11 days after last dose of alirocumab

  • Assessment of Lipoprotein particle size profiles

    baseline and at 2 days and at 11 days after last dose of alirocumab

  • Assessment of serum concentrations of PCSK9

    baseline and up to 2 weeks after last dose of alirocumab

  • +3 more secondary outcomes

Study Arms (1)

Placebo - Alirocumab

EXPERIMENTAL

Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks

Drug: alirocumabDrug: Placebo

Interventions

alirocumabDRUG

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Also known as: SAR236553, REGN727, Praluent
Placebo - Alirocumab
PlaceboDRUG

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Placebo - Alirocumab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site Number 840001

New York, New York, 10032, United States

Location

Related Publications (1)

  • Reyes-Soffer G, Pavlyha M, Ngai C, Thomas T, Holleran S, Ramakrishnan R, Karmally W, Nandakumar R, Fontanez N, Obunike J, Marcovina SM, Lichtenstein AH, Matthan NR, Matta J, Maroccia M, Becue F, Poitiers F, Swanson B, Cowan L, Sasiela WJ, Surks HK, Ginsberg HN. Effects of PCSK9 Inhibition With Alirocumab on Lipoprotein Metabolism in Healthy Humans. Circulation. 2017 Jan 24;135(4):352-362. doi: 10.1161/CIRCULATIONAHA.116.025253. Epub 2016 Dec 16.

    PMID: 27986651RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

alirocumab

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Single-sequence crossover
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 10, 2013

Study Start

December 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

US(1)