LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

Phase 2

Completed

• Conditions: Hyperlipidemia
• Interventions: Other: Placebo to Evolocumab; Biological: Evolocumab

• Registration Number: NCT01380730
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Study Start: 2011-07-01
• Primary Completion: 2012-04-05
• Study Completion: 2012-04-05
• Disposition First Submitted: 2013-03-26
• Disposition First Submitted QC: 2013-04-02
• Disposition First Posted: 2013-04-09
• Results First Submitted: 2015-09-01
• Results First Submitted QC: 2015-09-01
• Results First Posted: 2015-10-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 631

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Q2W	Placebo to Evolocumab	Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Evolocumab 280 mg Q4W	Evolocumab	Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 70 mg Q2W	Evolocumab	Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 140 mg Q2W	Evolocumab	Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 350 mg Q4W	Evolocumab	Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Placebo Q4W	Placebo to Evolocumab	Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Evolocumab 105 mg Q2W	Evolocumab	Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 420 mg Q4W	Evolocumab	Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12	Baseline and Week 12	LDL-C was measured using ultracentrifugation.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12	Baseline and Week 12
Change From Baseline in LDL-C at Week 12	Baseline and Week 12	LDL-C was measured using ultracentrifugation.
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12	Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12	Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at Week 12	Baseline and Week 12

Trial Locations

Locations (1)

Research Site; 🇭🇺 Zalaegerszeg, Hungary