Efficacy and Safety of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY Combo I)

• Percent change in LDL-C [ Time Frame: From baseline to weeks 12 and 52 ] [ Designated as safety issue: No ]
• Percent change in other lipid parameters [ Time Frame: From baseline to weeks 12, 24 and 52 ] [ Designated as safety issue: No ]

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by SAR236553 (REGN727) as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk patients with hypercholesterolemia.

Secondary Objectives:

• To evaluate the effect of SAR236553 (REGN727) in comparison with placebo on LDL-C at other time points.
• To evaluate the effect of SAR236553 (REGN727) on other lipid parameters.
• To evaluate the safety and tolerability of SAR236553 (REGN727).

The maximum study duration will be 62 weeks per patient, including a 2 week screening period, 52 week randomized treatment period, and 8 week follow-up 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
  Intervention: Drug: SAR236553 (REGN727)
• Placebo Comparator: Placebo
  Injection through subcutaneous (SC) administration
  Intervention: Other: Placebo

Inclusion criteria:

Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks to 6 weeks prior to screening (Week -2).

Exclusion criteria:

• Age < 18 or legal age of adulthood, whichever is greater.
• Patients without established CHD or CHD risk equivalent.
• LDL-C <70 mg/dL (<1.81 mmol/L) and patients with a history of documented cardiovascular disease.
• LDL-C <100 mg/dL (<2.59 mmol/L) and patients without a history of documented cardiovascular disease.
• Not on a stable dose of LMT (including statin) for at least 4 Weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (Week -2) and from screening to randomization.
• Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.