Phase 3
Completed N=1,899
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
Source: ClinicalTrials.gov NCT01763866 ↗Enrolled (actual)
1,899
Serious AEs
2.0%
Results posted
Dec 2015
Primary outcomePrimary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 — 9.86; 0.97; -21.96; -17.08 percent change — p=<0.001
Summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
9.86; 0.97; -21.96; -17.08; -61.56; -58.19 | <0.001 sig |
| PRIMARY Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 |
8.54; 0.35; -23.88; -18.98; -61.41; -62.47 | <0.001 sig |
| SECONDARY Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 |
6.8; -0.4; -32.4; -25.1; -76.8; -80.1 | <0.001 sig |
| SECONDARY Change From Baseline in LDL-C at Week 12 |
8.6; 0.8; -30.1; -23.3; -77.0; -75.1 | <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 |
6.80; 1.28; -20.71; -16.56; -53.48; -56.09 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 |
8.25; 2.43; -18.27; -14.78; -53.39; -52.20 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 |
7.55; 0.81; -17.29; -11.43; -50.95; -51.44 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 12 |
7.89; 0.21; -15.98; -10.95; -50.90; -47.15 | <0.001 sig |
| SECONDARY Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 |
5.96; 2.24; -14.39; -10.86; -40.44; -42.45 | <0.001 sig |
| SECONDARY Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 |
6.09; 2.80; -12.14; -9.85; -40.74; -40.07 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 |
6.41; 0.78; -15.77; -11.47; -53.56; -53.33 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 |
6.13; -1.21; -14.51; -12.33; -54.17; -49.65 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL |
5.7; 5.6; 20.0; 16.7; 88.1; 85.8 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 |
2.0; 5.9; 22.4; 19.2; 85.4; 84.2 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 |
6.07; -0.77; 1.44; 6.85; -26.01; -22.64 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12 |
7.34; -0.43; 3.29; 7.18; -25.87; -20.25 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 |
6.49; 9.17; -3.16; 1.57; -5.61; -13.38 | 0.20 |
| SECONDARY Percent Change From Baseline in Triglycerides at Week 12 |
8.27; 14.35; -0.43; 4.88; -3.79; -13.26 | 0.20 |
| SECONDARY Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 |
6.51; 9.53; -5.35; 1.77; -6.85; -11.77 | 0.088 |
| SECONDARY Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 |
8.32; 14.74; -4.61; 3.45; -6.16; -11.73 | 0.088 |
| SECONDARY Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 |
-0.99; -0.45; -1.13; -0.92; 5.54; 7.66 | 0.034 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 |
0.22; 0.01; -1.76; -0.40; 7.04; 7.88 | 0.034 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 to ≤ 80 years of age
- Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L)
- Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L)
- Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L)
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria
- Statin intolerance
- New York Heart association (NYHA) III or IV heart failure
- Uncontrolled hypertension
- Uncontrolled cardiac arrhythmia
- Type 1 diabetes, poorly controlled type 2 diabetes
- Uncontrolled hypothyroidism or hyperthyroidism
Data sourced from ClinicalTrials.gov (NCT01763866). 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.