Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

The duration of study participation depended on the status of the participant at screening:

- For participants receiving atorvastatin 10 mg, 20 mg, or 40 mg at a stable dose for at
least 6 weeks prior to screening, the study participation was to be approximately 21
weeks including a screening period of 1 week, a double-blind treatment period of 12
weeks and a follow-up period of 8 weeks.

- 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
screening, or drug naive participants, the study participation was to be approximately
27 weeks including a screening period of 1 week, a run-in treatment period with
atorvastatin 10 mg, 20 mg, or 40 mg at a stable dose of 6 weeks, a double-blind
treatment period of 12 weeks, and a follow-up period of 8 weeks.

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.