Phase 3
Completed N=89
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
Primary Hyperlipidemia and Mixed Dyslipidemia
Source: ClinicalTrials.gov NCT02189837 ↗
Enrolled (actual)
89
Serious AEs
1.2%
Results posted
Aug 2016
Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR) — -5.07; 74.13; 83.70; 310.48 percent change — p=0.018
◆ Published Evidence
Highly cited
147citations · ~18 / year
Controlled study of the effect of proprotein convertase subtilisin-kexin type 9 inhibition with evolocumab on lipoprotein(a) particle kinetics.
Summary
This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.
Linked Publications (3)
-
Controlled study of the effect of proprotein convertase subtilisin-kexin type 9 inhibition with evolocumab on lipoprotein(a) particle kinetics.
-
Factorial Effects of Evolocumab and Atorvastatin on Lipoprotein Metabolism.
-
Lipoprotein(a) Particle Production as a Determinant of Plasma Lipoprotein(a) Concentration Across Varying Apolipoprotein(a) Isoform Sizes and Background Cholesterol-Lowering Therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR) |
-5.07; 74.13; 83.70; 310.48 | 0.018 sig |
| SECONDARY Percent Change From Baseline in LDL-C at Day 50 |
-0.65; -45.25; -57.79; -83.19 | <0.001 sig |
| SECONDARY Percent Change From Baseline in LDL Apolipoprotein B-100 Production Rate (PR) |
-3.80; -3.27; -20.45; -35.93 | 0.11 |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) Fractional Catabolic Rate (FCR) |
7.49; 25.52; 5.37; 64.57 | 0.87 |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) Production Rate (PR) |
3.52; -6.88; -35.91; 16.40 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Fasting LDL-C at screening ≥ 100 mg/dL and ≤ 190 mg/dL
- Fasting triglycerides ≤ 150 mg/dL
- Body mass index (BMI) between 18.0 and 32.0 kg/m^2
- Framingham cardiac risk score 10% or less
Exclusion Criteria
- Treatment with a lipid-regulating drug or over the counter supplement in the last 3 months prior to screening
- History of coronary heart disease (CHD) or CHD equivalent
- Uncontrolled hypertension
- Diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT02189837) and the linked publication. 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.