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

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Placebo to Evolocumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Hypercholesterolemia, Proprotein convertase subtilisin/kexin type 9 (PCSK9)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo Q2W

Placebo Q4W

Evolocumab 70 mg Q2W

Evolocumab 105 mg Q2W

Evolocumab 140 mg Q2W

Evolocumab 280 mg Q4W

Evolocumab 350 mg Q4W

Evolocumab 420 mg Q4W

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 23, 2011
Last Updated
November 10, 2022
Sponsor
Amgen
Collaborators
TIMI Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT01380730
Brief Title
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
Acronym
LAPLACE
Official Title
LAPLACE TIMI 57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2011 (Actual)
Primary Completion Date
April 5, 2012 (Actual)
Study Completion Date
April 5, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
Collaborators
TIMI Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Hypercholesterolemia, Proprotein convertase subtilisin/kexin type 9 (PCSK9)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
631 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Q2W
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Arm Title
Placebo Q4W
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Arm Title
Evolocumab 70 mg Q2W
Arm Type
Experimental
Arm Description
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Arm Title
Evolocumab 105 mg Q2W
Arm Type
Experimental
Arm Description
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Arm Title
Evolocumab 140 mg Q2W
Arm Type
Experimental
Arm Description
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Arm Title
Evolocumab 280 mg Q4W
Arm Type
Experimental
Arm Description
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Arm Title
Evolocumab 350 mg Q4W
Arm Type
Experimental
Arm Description
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Arm Title
Evolocumab 420 mg Q4W
Arm Type
Experimental
Arm Description
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Administered by subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Placebo to Evolocumab
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Description
LDL-C was measured using ultracentrifugation.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in LDL-C at Week 12
Description
LDL-C was measured using ultracentrifugation.
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Research Site
City
Malvern
State/Province
Arkansas
ZIP/Postal Code
72104
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United States
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Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
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Research Site
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Research Site
City
Roseville
State/Province
California
ZIP/Postal Code
95747
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United States
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Research Site
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
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United States
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Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
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United States
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Research Site
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Littleton
State/Province
Colorado
ZIP/Postal Code
80120
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United States
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Research Site
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Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
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United States
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Research Site
City
Green Cove Springs
State/Province
Florida
ZIP/Postal Code
32043
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United States
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Research Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
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United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
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United States
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Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
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United States
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Research Site
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Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
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United States
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Research Site
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Peoria
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Illinois
ZIP/Postal Code
61614
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United States
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Research Site
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Hammond
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Indiana
ZIP/Postal Code
46320
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United States
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Research Site
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Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
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United States
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Research Site
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Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
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United States
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Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
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United States
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Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
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United States
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Research Site
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Auburn
State/Province
Maine
ZIP/Postal Code
04210
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United States
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Research Site
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Bangor
State/Province
Maine
ZIP/Postal Code
04401
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United States
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Research Site
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Portland
State/Province
Maine
ZIP/Postal Code
04101
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United States
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Research Site
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Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
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United States
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Research Site
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Marquette
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Michigan
ZIP/Postal Code
49855
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United States
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Research Site
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Ypsilanti
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Michigan
ZIP/Postal Code
48197
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United States
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Research Site
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Tupelo
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Mississippi
ZIP/Postal Code
38801
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United States
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Research Site
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Great Falls
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Montana
ZIP/Postal Code
59405
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United States
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Research Site
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Voorhees
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New Jersey
ZIP/Postal Code
08043
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United States
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Research Site
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Cortlandt Manor
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New York
ZIP/Postal Code
10567
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United States
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Williamsville
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New York
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14221
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United States
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Smithfield
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North Carolina
ZIP/Postal Code
27577
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United States
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Winston-Salem
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North Carolina
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27103
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United States
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Canton
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Ohio
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44708
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United States
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Research Site
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Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
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United States
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Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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United States
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Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Research Site
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44906
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United States
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Research Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
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United States
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Research Site
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
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United States
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Research Site
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
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United States
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Research Site
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Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
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United States
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Research Site
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Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15216
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United States
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Research Site
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York
State/Province
Pennsylvania
ZIP/Postal Code
17405
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United States
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Florence
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South Carolina
ZIP/Postal Code
29501
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United States
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Spartanburg
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South Carolina
ZIP/Postal Code
29302
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United States
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Rapid City
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South Dakota
ZIP/Postal Code
57701
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United States
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Jackson
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Tennessee
ZIP/Postal Code
38301
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United States
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Jackson
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Tennessee
ZIP/Postal Code
38305
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United States
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Houston
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Texas
ZIP/Postal Code
77002
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United States
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Houston
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Texas
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77074
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United States
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Research Site
City
Tacoma
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Washington
ZIP/Postal Code
98405
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United States
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Research Site
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Madison
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Wisconsin
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53713
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United States
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Research Site
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Burnaby
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British Columbia
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V5G 1T4
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Canada
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Research Site
City
Kelowna
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British Columbia
ZIP/Postal Code
V1Y 1V6
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
Facility Name
Research Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5K8
Country
Canada
Facility Name
Research Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2J9
Country
Canada
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K1
Country
Canada
Facility Name
Research Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2T7
Country
Canada
Facility Name
Research Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3C 5K7
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M8V 3X8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Research Site
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4S 5P5
Country
Canada
Facility Name
Research Site
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 6S9
Country
Canada
Facility Name
Research Site
City
Lachine
State/Province
Quebec
ZIP/Postal Code
H8S 2E4
Country
Canada
Facility Name
Research Site
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J4N 0C9
Country
Canada
Facility Name
Research Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
603 00
Country
Czechia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Research Site
City
Slany
ZIP/Postal Code
274 01
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Czechia
Facility Name
Research Site
City
Svitavy
ZIP/Postal Code
568 25
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Czechia
Facility Name
Research Site
City
Usti nad Orlici
ZIP/Postal Code
562 18
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Czechia
Facility Name
Research Site
City
Znojmo
ZIP/Postal Code
669 02
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Czechia
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Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Ballerup
ZIP/Postal Code
2750
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Denmark
Facility Name
Research Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Research Site
City
Dunaujvaros
ZIP/Postal Code
2400
Country
Hungary
Facility Name
Research Site
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Research Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Research Site
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Research Site
City
Komarom
ZIP/Postal Code
2991
Country
Hungary
Facility Name
Research Site
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Research Site
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
23141813
Citation
Giugliano RP, Desai NR, Kohli P, Rogers WJ, Somaratne R, Huang F, Liu T, Mohanavelu S, Hoffman EB, McDonald ST, Abrahamsen TE, Wasserman SM, Scott R, Sabatine MS; LAPLACE-TIMI 57 Investigators. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study. Lancet. 2012 Dec 8;380(9858):2007-17. doi: 10.1016/S0140-6736(12)61770-X. Epub 2012 Nov 6.
Results Reference
background
PubMed Identifier
22714699
Citation
Kohli P, Desai NR, Giugliano RP, Kim JB, Somaratne R, Huang F, Knusel B, McDonald S, Abrahamsen T, Wasserman SM, Scott R, Sabatine MS. Design and rationale of the LAPLACE-TIMI 57 trial: a phase II, double-blind, placebo-controlled study of the efficacy and tolerability of a monoclonal antibody inhibitor of PCSK9 in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2012;35(7):385-91. doi: 10.1002/clc.22014. Epub 2012 Jun 19.
Results Reference
background
PubMed Identifier
23884353
Citation
Desai NR, Kohli P, Giugliano RP, O'Donoghue ML, Somaratne R, Zhou J, Hoffman EB, Huang F, Rogers WJ, Wasserman SM, Scott R, Sabatine MS. AMG145, a monoclonal antibody against proprotein convertase subtilisin kexin type 9, significantly reduces lipoprotein(a) in hypercholesterolemic patients receiving statin therapy: an analysis from the LDL-C Assessment with Proprotein Convertase Subtilisin Kexin Type 9 Monoclonal Antibody Inhibition Combined with Statin Therapy (LAPLACE)-Thrombolysis in Myocardial Infarction (TIMI) 57 trial. Circulation. 2013 Aug 27;128(9):962-9. doi: 10.1161/CIRCULATIONAHA.113.001969. Epub 2013 Jul 24.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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