Phase 2 Completed N=160 Randomized Quadruple-blind Treatment

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

Hyperlipidemia

Source: ClinicalTrials.gov NCT01375764 ↗

Enrolled (actual)

160

Serious AEs

2.6%

Results posted

Dec 2015

Primary outcomePrimary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 — -14.76; -40.77; -42.58; -50.70 percent change — p=<0.001

Summary

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12	-14.76; -40.77; -42.58; -50.70	<0.001 sig
PRIMARY Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe	-15.70; -62.98	<0.001 sig
SECONDARY Change From Baseline in LDL-C at Week 12	-14.2; -66.8; -69.7; -90.8	<0.001 sig
SECONDARY Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe	-17.9; -109.8	<0001
SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12	-14.97; -39.83; -41.63; -48.58	<0.001 sig
SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe	-14.83; -59.82	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 12	-12.20; -33.58; -34.33; -42.07	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe	-10.84; -49.06	<0.001 sig
SECONDARY Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12	-9.61; -31.97; -33.52; -40.56	<0.001 sig
SECONDARY Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe	-11.52; -49.44	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12	-11.36; -36.46; -38.17; -45.41	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe	-10.74; -51.99	<0.001 sig

Eligibility Criteria

Inclusion Criteria

Male or female ≥ 18 to ≤ 75 years of age
On a statin or a low dose statin with stable dose for at least 4 weeks
Lipid lowering therapy has been stable prior to enrollment
Fasting triglycerides must be 8.5%)
Uncontrolled hypertension

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01375764). 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.