Efficacy and Safety of Alirocumab (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 calculated LDL-C at Week 12 and 52 [ Time Frame: From baseline up to Week 52 ] [ Designated as safety issue: No ]
• Percent change in other lipid parameters at Week 12, Week 24 and 52 [ Time Frame: From baseline up to Week 52 ] [ Designated as safety issue: No ]
• Percent change in calculated LDL-C at Week 78 [ Time Frame: From baseline up to Week 78 ] [ Designated as safety issue: No ]
  From a mixed-effect model including all LDL-C values collected up to Week 78
• Percent change in other lipid parameters at Week 78 [ Time Frame: From baseline up to Week 78 ] [ Designated as safety issue: No ]

• 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 ]

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

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

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

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

• Drug: Alirocumab

  Pharmaceutical form: Solution for injection

  Route of administration: Subcutaneous

  Other Names:

  • SAR236553
  • REGN727
• Drug: Placebo

  Pharmaceutical form: Solution for injection

  Route of administration: Subcutaneous

• Experimental: Alirocumab

  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: Alirocumab
• 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 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.