Efficacy and Safety of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy (ODYSSEY FH I)

• Percent change in LDL-C [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]
• Percent change in other lipid parameters [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]

Primary Objective: To evaluate the effect of SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo Secondary Objectives: -To evaluate the effect of SAR236553 (REGN727) in comparison with placebo on LDL-C at other time points -To evaluate the effects of SAR236553 (REGN727) on other lipid parameters -To evaluate the safety and tolerability of SAR236553 (REGN727)

The maximum study duration will be 89 weeks per patient, including a 78-week randomized treatment period.

• Drug: SAR236553 (REGN727)

  SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

  Pharmaceutical form:Solution for injection Route of administration: subcutaneous

• Other: placebo
  Pharmaceutical form:Solution for injection Route of administration: subcutaneous

• Experimental: SAR236553 (REGN727)
  Injection through subcutaneous (SC) administration. Background statin therapy or other lipid lowering therapy will be administered according to site investigator discretion as background therapy.
  Intervention: Drug: SAR236553 (REGN727)
• Placebo Comparator: Placebo
  Injection through subcutaneous (SC) administration. Background statin therapy or other lipid lowering therapy will be administered according to site investigator discretion as background therapy.
  Intervention: Other: placebo

Inclusion criteria:

• Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid-modifying therapy

Exclusion criteria:

• Age < 18 years or legal age of adulthood, whichever is greater -LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
• LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
• Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L)
• Known history of homozygous familial hypercholesterolemia
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.