Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy
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.; Orally once daily at a stable dose of 10 mg, 20 mg, or 40 mg as background therapy.
Intervention MeSH terms: Atorvastatin; Alirocumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Primary Objective:

        -  To evaluate the effect of alirocumab (SAR236553/REGN727) 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 receiving a lipid-lowering treatment
             other than atorvastatin or not at stable dose of atorvastatin 10 mg, 20 mg, or 40 mg
             for at least 6 weeks prior to screening period or drug naive participants if they are
             likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L)
             at the end of the 6-week run-in treatment period on atorvastatin therapy

        OR

          -  Participants with primary hypercholesterolemia treated with atorvastatin at stable
             dose of 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to screening period and
             likely to have LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) at the screening visit

        Exclusion criteria:

          1. LDL-C < 100 mg/dL (< 2.59 mmol/L):

               -  After the run-in period on atorvastatin (10 mg, 20 mg, or 40 mg) for participants
                  receiving a lipid-lowering treatment other than atorvastatin or not at stable
                  dose of atorvastatin 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to the
                  screening, or drug naive participant

             OR

               -  At the first visit for participants who were being treated with stable dose of
                  atorvastatin (10 mg, 20 mg, or 40 mg) for at least 6 weeks prior to screening

          2. Participants not previously instructed on a cholesterol-lowering diet

          3. Participants with type 1 diabetes

          4. Participants with type 2 diabetes treated with insulin

          5. Participants with type 2 diabetes and with an glycated hemoglobin (HbA1c) ≥ 8.5% at
             screening visit (considered poorly controlled)

          6. Laboratory findings measured before randomization:

               -  Triglycerides (TG) > 350 mg/dL (> 3.95 mmol/L) at screening visit

               -  Positive serum or urine pregnancy test in females of childbearing potential

          7. Pregnant or breast-feeding women

          8. Women of childbearing potential with no effective contraceptive method

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.