Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Placebo (for alirocumab); Alirocumab; Lipid-Modifying Therapy (LMT)
Intervention description: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).; Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).; Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 316.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein
      convertase subtilisin/kexin type 9 (PCSK9).

      Primary Objective of the study:

        -  To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by
           alirocumab 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 participants with hypercholesterolemia

      Secondary Objectives:

        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time
           points

        -  To evaluate the effect of alirocumab on other lipid parameters

        -  To evaluate the safety and tolerability of alirocumab
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with hypercholesterolemia and established coronary heart disease (CHD) or
             CHD risk equivalents who were 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 was greater

          -  Participants without established CHD or CHD risk equivalent

          -  LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented
             cardiovascular disease

          -  LDL-C <100 mg/dL (<2.59 mmol/L) and participants 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
        participant's potential participation in a clinical trial.