Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))

A RaNdomized Double-blInd Placebo ConTrolled Study Characterizing THe Effects of PCSK9 Inhibition On Arterial Wall Inflammation in Patients With Elevated Lp(a) (ANITSCHKOW)

A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).

Inclusion Criteria:

• Fasting lipoprotein(a) (Lp(a)) 50 mg/dL or more at screening 1
• Fasting Low-density lipoprotein-cholesterol (LDL-C) 100 mg/dL or more at screening 1
• Lipid lowering therapy including statin dose unchanged for at least 8 weeks prior to screening
• Target-to-background ratio (TBR) maximum higher than 1.6 (either right, left carotid or thoracic aorta) on fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT).

Exclusion Criteria:

• Currently receiving, or less than 4 weeks since receiving, treatment in another investigational device or drug study(ies), or participating in other investigational procedures
• Known diagnosis of diabetes mellitus or screening fasting serum glucose ≥ 126 mg/dL or hemoglobin A1C (HbA1C) ≥ 6.5%
• Subject with a history of homozygous familial hypercholesterolemia
• History of a Cardiovascular event
• Subject currently undergoing lipid apheresis
• Known contraindications or limitations to FDG-PET/ CT (scanner weight limit, devices that can cause image artifacts, or carotid/aortic stents/grafts
• Subject has had exposure to investigational drugs targeting Lp(a) within the last 12 months, prior to Screening
• Other Exclusion Criteria May Apply.