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

Completed · Phase 3 · Has a placebo group

Conditions studied: Subjects With Hyperlipidemia, Dyslipidemia

In brief

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).

Key facts

Study ID: NCT02729025
Run by: Amgen
People needed: 129
Starts: 2016-04-14
Expected to finish: 2018-04-05
Last updated by the study team: 2022-09-23

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

Research Site — Miami, Florida, United States
Research Site — Las Vegas, Nevada, United States
Research Site — Mooresville, North Carolina, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Hurst, Texas, United States
Research Site — Newmarket, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Chicoutimi, Quebec, Canada
Research Site — Québec, Quebec, Canada
Research Site — Amsterdam, Netherlands
Research Site — Apeldoorn, Netherlands
Research Site — Nijmegen, Netherlands
Research Site — Rotterdam, Netherlands
Research Site — Venlo, Netherlands
Research Site — Waalwijk, Netherlands

Full record on ClinicalTrials.gov

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