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

Amgen

Status and phase: Completed; Phase 2

Conditions: Hyperlipidemia

Treatments: Other: Placebo to Evolocumab; Biological: Evolocumab

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01380730

20101155

Details and patient eligibility

About

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.

Enrollment: 631 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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631 participants in 8 patient groups, including a placebo group

Placebo Q2W

Placebo Comparator group

Description:

Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.

Treatment:

Other: Placebo to Evolocumab

Placebo Q4W

Placebo Comparator group

Description:

Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.

Treatment:

Other: Placebo to Evolocumab

Evolocumab 70 mg Q2W

Experimental group

Description:

Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Treatment:

Biological: Evolocumab

Evolocumab 105 mg Q2W

Experimental group

Description:

Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Treatment:

Biological: Evolocumab

Evolocumab 140 mg Q2W

Experimental group

Description:

Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Treatment:

Biological: Evolocumab

Evolocumab 280 mg Q4W

Experimental group

Description:

Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Treatment:

Biological: Evolocumab

Evolocumab 350 mg Q4W

Experimental group

Description:

Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Treatment:

Biological: Evolocumab

Evolocumab 420 mg Q4W

Experimental group

Description:

Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Treatment:

Biological: Evolocumab