A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

Purpose

This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels). The aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug once a week - How much study drug is in the blood at different times

Condition

  • Hypercholesterolemia

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Participant has elevated LDL-C level, as defined in the protocol

Exclusion Criteria

  1. Participant plans to initiate or change dose of lipid-lowering therapy 2. Use of any PCSK9 inhibitors NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 - Low Dose
  • Drug: Alirocumab
    Administered per the protocol
    Other names:
    • Praluent®
    • REGN727
    • SAR236553
Experimental
Arm 2 - Medium Dose
  • Drug: Alirocumab
    Administered per the protocol
    Other names:
    • Praluent®
    • REGN727
    • SAR236553
Experimental
Arm 3 - High Dose
  • Drug: Alirocumab
    Administered per the protocol
    Other names:
    • Praluent®
    • REGN727
    • SAR236553
Experimental
Arm 4 - Control Dose
  • Drug: Alirocumab
    Administered per the protocol
    Other names:
    • Praluent®
    • REGN727
    • SAR236553

Recruiting Locations

Precision Clinical Research
Sunrise, Florida 33351

Balanced Life Health Care Solutions
Lawrenceville, Georgia 30046

Mercury Street Medical Group, PLLC
Butte, Montana 59701

Velocity Clinical Research - Durham
Durham, North Carolina 27701

Velocity Clinical Research, Medford
Medford, Oregon 97504

Velocity Clinical Research Dallas
Dallas, Texas 75230

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com