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

• Status: Completed
• Trial end date: 2018-04-05
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Evolocumab

Criteria

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.