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)

The maximum study duration was 62 weeks per participant, including a 2-week screening
period, 52-week randomized treatment period, and 8-week follow-up period.

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.