Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Total study duration per patient is expected to be up to 18 weeks, with up to 2 weeks of
screening period and 16 weeks of study treatment period.

Inclusion criteria :

- Patients are in either category A or B (below), and are not adequately controlled with
a stable daily dose of atorvastatin (20 mg or 40 mg), or rosuvastatin (10 mg or 20 mg)
for at least 4 weeks prior to the screening visit (Week -2), with or without other
lipid-modifying therapy (LMT):

- A. Patients with heterozygous familial hypercholesterolemia (heFH) (diagnosis
based on either genotyping or clinical criteria) OR

- B. Non-FH patients at high or very high cardiovascular (CV) risk. High and very
high cardiovascular risk patients include patients with coronary heart disease
(CHD), non-CHD cardiovascular disease (CVD), and other risk factors.

- Patient willing and able to self-inject for the duration of the study.

Exclusion criteria:

- Low-density lipoprotein cholesterol (LDL-C) <70 mg/dL (<1.81 mmol/L) at the screening
visit.

- Currently taking a daily dose of statin that is not atorvastatin 20 mg or 40 mg, or
rosuvastatin 10 mg or 20 mg.

- Not on a stable dose of LMT (including statin) for at least 4 weeks, prior to the
screening visit and from screening to randomization.

- Having previously used any device for the proprotein convertase subtilisin/kexin type
9 (PCSK9) inhibitor administration, or having participated in any clinical trial for a
PCSK9 inhibitor.

- Fasting serum Triglyceride (TG) >400 mg/dL (>4.52 mmol/L) at the screening visit.

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