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Phase 2 Completed N=411 Randomized Quadruple-blind Treatment

Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

Hyperlipidemia
Source: ClinicalTrials.gov NCT01375777 ↗
Enrolled (actual)
411
Serious AEs
0.7%
Results posted
Oct 2015
Primary outcomePrimary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 — -3.71; 4.54; -14.26; -40.98 percent change — p=<0.001

Summary

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12		 -3.71; 4.54; -14.26; -40.98; -43.87; -50.93 <0.001 sig
SECONDARY
Change From Baseline in LDL-C at Week 12		 -3.4; 7.3; -19.2; -55.7; -66.0; -69.3 <0.001 sig
SECONDARY
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12		 -2.89; -0.25; -15.53; -37.95; -39.68; -48.04 <0.001 sig
SECONDARY
Percent Change From Baseline in Apolipoprotein B at Week 12		 -0.33; 0.19; -11.17; -32.66; -36.20; -44.52 <0.001 sig
SECONDARY
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12		 -1.21; -3.39; -16.65; -30.07; -33.13; -38.70 <0.001 sig
SECONDARY
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12		 2.03; 0.14; -12.35; -32.80; -38.30; -48.13 <0.001 sig

Eligibility Criteria

Inclusion Criteria

  • Male or female ≥ 18 to ≤ 75 years of age
  • Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL
  • Framingham risk score of 10% or less
  • Fasting triglycerides < 400 mg/dL

Exclusion Criteria

  • History of coronary heart disease
  • New York Heart Association (NYHA) II - IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01375777). 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.

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