Phase 3 Completed N=307 Randomized Quadruple-blind Treatment

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

Hyperlipidemia

Source: ClinicalTrials.gov NCT01763905 ↗

Enrolled (actual)

307

Serious AEs

3.3%

Results posted

Dec 2015

Primary outcomePrimary: Percent Change From Baseline in LDL-C at Week 12 — -18.08; -15.05; -56.14; -52.60 percent change — p=<0.001

Summary

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in LDL-C at Week 12	-18.08; -15.05; -56.14; -52.60	<0.001 sig
PRIMARY Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	-19.21; -16.62; -56.11; -55.31	<0.001 sig
SECONDARY Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	-39.1; -33.0; -105.4; -103.6	<0.001 sig
SECONDARY Change From Baseline in LDL-C at Week 12	-36.2; -30.2; -106.0; -99.0	<0.001 sig
SECONDARY Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)	2.0; 0.0; 45.5; 42.0	<0.001 sig
SECONDARY Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12	2.0; 0.0; 50.0; 37.5	<0.001 sig
SECONDARY Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12	-17.18; -14.54; -48.72; -49.13	<0.001 sig
SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12	-16.53; -13.16; -48.62; -46.15	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12	-13.67; -11.02; -45.88; -46.01	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 12	-12.95; -9.97; -45.81; -43.07	<0.001 sig
SECONDARY Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12	-13.44; -11.20; -40.83; -41.14	<0.001 sig
SECONDARY Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12	-14.13; -9.92; -40.42; -38.57	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12	-13.00; -11.94; -47.86; -48.31	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12	-13.14; -11.37; -47.66; -45.51	<0.001 sig
SECONDARY Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12	-2.30; 1.55; -26.20; -23.72	<0.001 sig
SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 12	-1.74; 5.81; -27.03; -22.07	<0.001 sig
SECONDARY Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12	-3.74; -0.32; -6.32; -6.73	0.97
SECONDARY Percent Change From Baseline in Triglycerides at Week 12	-5.47; 2.16; -3.88; -2.53	0.97
SECONDARY Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12	0.33; 1.44; 5.48; 7.18	0.068
SECONDARY Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12	1.77; 1.64; 5.34; 6.47	0.068
SECONDARY Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12	-5.76; -2.93; -7.60; -6.46	0.97
SECONDARY Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12	-5.49; -2.25; -6.16; -2.18	0.97

Eligibility Criteria

Inclusion Criteria

Male or female ≥ 18 to ≤ 80 years of age
Not on a statin or on a low dose statin with stable dose for at least 4 weeks
History of intolerance to at least 2 statins
Subject not at LDL-C goal
Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.
Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria

New York Heart Association (NYHA) III or IV heart failure
Uncontrolled cardiac arrhythmia
Uncontrolled hypertension
Type 1 diabetes, poorly controlled type 2 diabetes
Uncontrolled hypothyroidism or hyperthyroidism

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01763905). 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.