Phase 3
Completed N=129
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
Subjects With Hyperlipidemia, Dyslipidemia
Source: ClinicalTrials.gov NCT02729025 ↗
Enrolled (actual)
129
Serious AEs
1.6%
Results posted
Apr 2019
Primary outcomePrimary: Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16 — -5.31; -8.31 percent change — p=0.18
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16 |
-5.31; -8.31 | 0.18 |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16 |
1.06; -12.83 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16 |
1.64; -59.02 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B Concentration at Week 16 |
3.29; -48.30 | <0.0001 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02729025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.