Efficacy and Safety of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY High FH)

• Percent change in LDL-C - Time Frame: From baseline up to week 78 [ 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

• Drug: 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: Drug: placebo

Inclusion criteria:

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

Exclusion criteria:

• Age < 18 years
• LDL-C < 160 mg/dL (< 4.14 mmol/L) at the screening visit (Week-3).
• Fasting serum triglycerides > 400 mg/dL (> 4.52 mmol/L) during the screening period.
• 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.