Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Placebo (for alirocumab); Atorvastatin
Intervention description: Two SC injections in the abdomen only; Two subcutaneous (SC) injections in the abdomen only
Route of administration: subcutaneous injection (1 mL) in the abdomen; Orally once daily at a stable dose of 5 to 20 mg as background therapy
Route of administration: oral administration in the evening
Intervention MeSH terms: Atorvastatin; Alirocumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein
      convertase subtilisin/kexin type 9 (PCSK9).

      Primary Objective of the study:

      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels
      after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL
      (≥2.59 mmol/L) on ongoing stable atorvastatin therapy.

      Secondary Objectives:

        -  To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment
           in comparison with placebo

        -  To evaluate the safety and tolerability of alirocumab

        -  To evaluate the development of anti-alirocumab antibodies

        -  To evaluate the pharmacokinetics of alirocumab
    

Eligibility criteria:

        Inclusion criteria :

        - Participants with primary hypercholesterolemia treated with atorvastatin at stable dose
        of 5-20 mg for at least 6 weeks prior to screening and likely to have LDL-C ≥100 mg/dL
        (≥2.59 mmol/L) at the screening visit.

        OR

        - Participants with primary hypercholesterolemia who were receiving a lipid-lowering
        treatment other than atorvastatin, or who were not at stable dose of atorvastatin 5-20 mg
        for at least 6 weeks prior to screening if they were likely to have LDL-C ≥100 mg/dL (≥2.59
        mmol/L) after a 6-week run-in treatment period on atorvastatin therapy.

        Exclusion criteria:

          1. LDL-C <100 mg/dL (<2.59 mmol/L)

               -  at screening visit for participants who were being treated with stable dose of
                  atorvastatin 5-20 mg for at least 6 weeks prior to screening OR

               -  at the end of the 6-week run-in period on atorvastatin for participants receiving
                  a lipid lowering treatment other than atorvastatin, or not at stable dose of
                  atorvastatin 5-20 mg for at least 6 weeks prior to screening

          2. Participants with type 1 diabetes

          3. Participants with type 2 diabetes treated with insulin, or without, and considered
             poorly controlled at screening.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.