Phase 2
Completed N=631
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
Source: ClinicalTrials.gov NCT01380730 ↗Enrolled (actual)
631
Serious AEs
2.4%
Results posted
Oct 2015
Primary outcomePrimary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 — 2.76; -0.98; -39.06; -57.48 percent change — p=<0.001
Summary
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
2.76; -0.98; -39.06; -57.48; -63.34; -42.82 | <0.001 sig |
| SECONDARY Change From Baseline in LDL-C at Week 12 |
-0.2; -3.2; -50.9; -77.6; -79.5; -53.7 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 |
2.21; -1.26; -36.23; -53.21; -59.19; -39.05 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 12 |
5.86; 3.22; -28.88; -44.29; -50.59; -31.16 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 |
2.64; -2.00; -28.76; -40.73; -45.09; -29.73 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 |
-0.30; -0.35; -35.04; -47.60; -53.73; -34.11 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 to ≤ 80 years of age
- On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
- Fasting LDL-C ≥ 85 mg/dL
- Fasting triglycerides ≤ 400 mg/dL
Exclusion Criteria
- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
- Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) > 8.5%)
- Uncontrolled hypertension
- New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30%
- Uncontrolled cardiac arrhythmia
Data sourced from ClinicalTrials.gov (NCT01380730). 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.