Phase 3
Completed N=615
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
Source: ClinicalTrials.gov NCT01763827 ↗Enrolled (actual)
615
Serious AEs
1.0%
Results posted
Dec 2015
Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 — 0.10; -1.34; -17.75; -18.57 percent change — p=<0.001
Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 |
0.10; -1.34; -17.75; -18.57; -57.04; -56.12 | <0.001 sig |
| PRIMARY Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 |
-0.43; -1.41; -17.52; -19.12; -56.93; -58.81 | <0.001 sig |
| SECONDARY Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 |
1.2; 0.0; -23.1; -25.9; -78.4; -81.9 | <0.001 sig |
| SECONDARY Change From Baseline in LDL-C at Week 12 |
1.9; -0.1; -23.4; -25.0; -78.4; -77.9 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL |
0.0; 0.0; 1.3; 2.8; 73.6; 71.3 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 |
1.4; 0.0; 1.4; 1.4; 72.9; 65.4 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 |
-1.41; 1.32; -14.64; -16.48; -50.22; -51.96 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 |
-0.31; 1.51; -14.89; -16.48; -50.12; -49.68 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 |
0.05; 1.54; -13.47; -14.75; -47.04; -49.39 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 12 |
0.59; 1.84; -13.17; -14.02; -47.21; -46.59 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12 |
0.44; 6.42; -9.14; -11.90; -38.49; -39.41 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12 |
1.18; 7.02; -10.03; -12.34; -38.45; -37.65 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 |
1.01; 3.85; -13.39; -14.49; -48.12; -51.10 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 |
1.12; 4.51; -12.69; -14.29; -48.45; -48.26 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 |
0.12; 0.00; 0.00; -2.08; -18.37; -19.24 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 12 |
0.00; 0.00; 0.00; -2.05; -20.41; -17.82 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 |
-3.89; 4.89; -1.46; -3.97; -9.16; -15.71 | 0.72 |
| SECONDARY Percent Change From Baseline in Triglycerides at Week 12 |
-1.91; 2.01; 0.00; -2.41; -8.14; -15.64 | 0.72 |
| SECONDARY Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 |
-3.81; 4.22; -2.69; -3.33; -8.40; -16.17 | 0.072 |
| SECONDARY Percent Change From Baseline in VLDL-C at Week 12 |
-1.58; 0.00; -0.94; -3.61; -9.52; -16.33 | 0.72 |
| SECONDARY Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 |
-1.64; -4.67; -0.92; 0.00; 3.89; 3.81 | 0.007 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 |
-1.15; -5.27; -2.79; -1.47; 4.76; 4.06 | 0.007 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 to ≤ 80 years of age
- National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less
- Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria
- History of coronary heart disease
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)
- Uncontrolled hypothyroidism or hyperthyroidism
Data sourced from ClinicalTrials.gov (NCT01763827). 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.