Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Placebo (for alirocumab); Atorvastatin; Placebo (for atorvastatin)
Intervention description: One subcutaneous (SC) injection in the abdomen only.; One SC injection in the abdomen only.; Over-encapsulated tablet orally once daily in the evening with dinner.; One over-encapsulated tablet of placebo for atorvastatin orally once daily in the evening with dinner.
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: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: 10020603

Summary:

      Primary Objective:

      To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein
      cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of
      atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L)
      on atorvastatin 10 mg.

      Secondary Objectives:

        -  To evaluate the effects of alirocumab on other lipid levels in comparison with placebo,
           when co-administered with 80 mg of atorvastatin after 8 weeks of treatment.

        -  To evaluate the efficacy of alirocumab when co-administered with a high dose of
           atorvastatin (80 mg) versus atorvastatin 10 mg.

        -  To evaluate the safety and tolerability of alirocumab when co-administered with 2
           different doses of atorvastatin.

        -  To evaluate the development of anti-alirocumab antibodies.

        -  To evaluate the pharmacokinetics of alirocumab.
    

Eligibility criteria:

        Inclusion criteria:

        - Participants receiving a lipid-lowering treatment other than atorvastatin/ or not at
        stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive
        participants with primary hypercholesterolemia 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 stable dose of atorvastatin
        10 mg for at least 6 weeks prior to screening and likely to have low-density lipoprotein
        cholesterol (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) at Week -1 (V1):

               -  After the run-in period on atorvastatin 10 mg for participants receiving a lipid
                  lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin
                  10 mg for at least 6 weeks prior to the screening period, or drug naive
                  participants.

             OR

               -  At the first visit for participants who are being treated with atorvastatin 10 mg
                  at stable dose for at least 6 weeks prior to screening visit.

          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 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.