Conditions: Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief 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

Detailed description:
The duration of study participation depended on the status of the participant at screening: 21 to 27 weeks including a screening/run-in period of 1 to 7 weeks, a double-blind treatment period of 12 weeks, followed by an 8-week follow-up period.

Arms:
arm 1: Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose. arm 2: Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose. arm 3: Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose. arm 4: Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.

Interventions: intervention 1: Alirocumab intervention 2: Placebo (for alirocumab) intervention 3: Atorvastatin
Intervention descriptions: intervention 1: Two SC injections in the abdomen only intervention 2: Two subcutaneous (SC) injections in the abdomen only

Route of administration: subcutaneous injection (1 mL) in the abdomen intervention 3: Orally once daily at a stable dose of 5 to 20 mg as background therapy

Route of administration: oral administration in the evening

Protocol document: