Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

• Percent change in calculated LDL-C at Week 24 [ Time Frame: From baseline to Week 52 ] [ Designated as safety issue: No ]
  From a mixed-effect model including all LDL-C values collected up to Week 52
• 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, 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 ]

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 long-term safety and tolerability of alirocumab in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).

Secondary Objectives:

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

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

• Drug: Placebo

  Pharmaceutical form: Solution for injection

  Route of administration: Subcutaneous

• Drug: Alirocumab

  Pharmaceutical form: Solution for injection

  Route of administration: Subcutaneous

  Other Names:

  • SAR236553
  • REGN727

• Experimental: Alirocumab

  Injection through subcutaneous (SC) administration.

  Background statin therapy or other lipid modifying 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 modifying therapy will be administered according to site investigator discretion as background therapy.

  Intervention: Drug: Placebo

Inclusion criteria:

Either A or B below and who are not adequately controlled with their lipid-modifying therapy:

A) Patients with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents

OR

B) Patients with hypercholesterolemia together with established CHD or CHD risk equivalents.

Exclusion criteria:

• Age < 18 years
• LDL-C <70 mg/dL (< 1.81 mmol/L)
• 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.