LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
LAPLACE
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
1 other identifier
interventional
631
5 countries
100
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2011
Shorter than P25 for phase_2
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2012
CompletedResults Posted
Study results publicly available
October 1, 2015
CompletedNovember 15, 2022
November 1, 2022
9 months
June 23, 2011
September 1, 2015
November 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C was measured using ultracentrifugation.
Baseline and Week 12
Secondary Outcomes (5)
Change From Baseline in LDL-C at Week 12
Baseline and Week 12
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 Apolipoprotein B 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/Apolipoprotein A-1 Ratio at Week 12
Baseline and Week 12
Study Arms (8)
Placebo Q2W
PLACEBO COMPARATORParticipants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Placebo Q4W
PLACEBO COMPARATORParticipants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Evolocumab 70 mg Q2W
EXPERIMENTALParticipants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 105 mg Q2W
EXPERIMENTALParticipants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 140 mg Q2W
EXPERIMENTALParticipants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Evolocumab 280 mg Q4W
EXPERIMENTALParticipants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 350 mg Q4W
EXPERIMENTALParticipants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 420 mg Q4W
EXPERIMENTALParticipants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Interventions
Administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- The TIMI Study Groupcollaborator
Study Sites (100)
Research Site
Birmingham, Alabama, 35294, United States
Research Site
Tucson, Arizona, 85710, United States
Research Site
Malvern, Arkansas, 72104, United States
Research Site
Anaheim, California, 92801, United States
Research Site
Carmichael, California, 95608, United States
Research Site
Newport Beach, California, 92663, United States
Research Site
Roseville, California, 95747, United States
Research Site
Westlake Village, California, 91361, United States
Research Site
Colorado Springs, Colorado, 80909, United States
Research Site
Littleton, Colorado, 80120, United States
Research Site
Daytona Beach, Florida, 32117, United States
Research Site
Green Cove Springs, Florida, 32043, United States
Research Site
Melbourne, Florida, 32901, United States
Research Site
Miami, Florida, 33143, United States
Research Site
Miami, Florida, 33173, United States
Research Site
Port Charlotte, Florida, 33952, United States
Research Site
Peoria, Illinois, 61614, United States
Research Site
Hammond, Indiana, 46320, United States
Research Site
Indianapolis, Indiana, 46237, United States
Research Site
Valparaiso, Indiana, 46383, United States
Research Site
Iowa City, Iowa, 52242, United States
Research Site
Lexington, Kentucky, 40536, United States
Research Site
Auburn, Maine, 04210, United States
Research Site
Bangor, Maine, 04401, United States
Research Site
Portland, Maine, 04101, United States
Research Site
Kalamazoo, Michigan, 49048, United States
Research Site
Marquette, Michigan, 49855, United States
Research Site
Ypsilanti, Michigan, 48197, United States
Research Site
Tupelo, Mississippi, 38801, United States
Research Site
Great Falls, Montana, 59405, United States
Research Site
Voorhees Township, New Jersey, 08043, United States
Research Site
Cortlandt Manor, New York, 10567, United States
Research Site
Williamsville, New York, 14221, United States
Research Site
Smithfield, North Carolina, 27577, United States
Research Site
Winston-Salem, North Carolina, 27103, United States
Research Site
Canton, Ohio, 44708, United States
Research Site
Cincinnati, Ohio, 45212, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
Dayton, Ohio, 45414, United States
Research Site
Mansfield, Ohio, 44906, United States
Research Site
Marion, Ohio, 43302, United States
Research Site
Sandusky, Ohio, 44870, United States
Research Site
Camp Hill, Pennsylvania, 17011, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Pittsburgh, Pennsylvania, 15216, United States
Research Site
York, Pennsylvania, 17405, United States
Research Site
Florence, South Carolina, 29501, United States
Research Site
Spartanburg, South Carolina, 29302, United States
Research Site
Rapid City, South Dakota, 57701, United States
Research Site
Jackson, Tennessee, 38301, United States
Research Site
Jackson, Tennessee, 38305, United States
Research Site
Houston, Texas, 77002, United States
Research Site
Houston, Texas, 77074, United States
Research Site
Tacoma, Washington, 98405, United States
Research Site
Madison, Wisconsin, 53713, United States
Research Site
Burnaby, British Columbia, V5G 1T4, Canada
Research Site
Kelowna, British Columbia, V1Y 1V6, Canada
Research Site
Vancouver, British Columbia, V6Z 1Y6, Canada
Research Site
Victoria, British Columbia, V8T 5G1, Canada
Research Site
Cambridge, Ontario, N1R 6V6, Canada
Research Site
Greater Sudbury, Ontario, P3C 5K7, Canada
Research Site
Hamilton, Ontario, L8L 2X2, Canada
Research Site
London, Ontario, N5W 6A2, Canada
Research Site
London, Ontario, N6A 5K8, Canada
Research Site
Newmarket, Ontario, L3Y 5G8, Canada
Research Site
Oshawa, Ontario, L1J 2J9, Canada
Research Site
Oshawa, Ontario, L1J 2K1, Canada
Research Site
Sarnia, Ontario, N7T 4X3, Canada
Research Site
Scarborough Village, Ontario, M1P 2T7, Canada
Research Site
Toronto, Ontario, M8V 3X8, Canada
Research Site
Toronto, Ontario, M9V 4B4, Canada
Research Site
Woodstock, Ontario, N4S 5P5, Canada
Research Site
Gatineau, Quebec, J8Y 6S9, Canada
Research Site
Lachine, Quebec, H8S 2E4, Canada
Research Site
Longueuil, Quebec, J4N 0C9, Canada
Research Site
Pointe-Claire, Quebec, H9R 3J1, Canada
Research Site
Québec, Quebec, G1V 4M6, Canada
Research Site
Brno, 603 00, Czechia
Research Site
Brno, 625 00, Czechia
Research Site
Brno, 656 91, Czechia
Research Site
Olomouc, 775 20, Czechia
Research Site
Prague, 120 00, Czechia
Research Site
Prague, 140 21, Czechia
Research Site
Slaný, 274 01, Czechia
Research Site
Svitavy, 568 25, Czechia
Research Site
Ústí nad Orlicí, 562 18, Czechia
Research Site
Znojmo, 669 02, Czechia
Research Site
Aalborg, 9000, Denmark
Research Site
Ballerup Municipality, 2750, Denmark
Research Site
Vejle, 7100, Denmark
Research Site
Budapest, 1096, Hungary
Research Site
Debrecen, 4032, Hungary
Research Site
Dunaújváros, 2400, Hungary
Research Site
Eger, 3300, Hungary
Research Site
Gyula, 5700, Hungary
Research Site
Kecskemét, 6000, Hungary
Research Site
Komárom, 2991, Hungary
Research Site
Mosonmagyaróvár, 9200, Hungary
Research Site
Szolnok, 5004, Hungary
Research Site
Zalaegerszeg, 8900, Hungary
Related Publications (3)
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.
PMID: 23141813BACKGROUNDKohli 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.
PMID: 22714699BACKGROUNDDesai 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.
PMID: 23884353DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
July 1, 2011
Primary Completion
April 5, 2012
Study Completion
April 5, 2012
Last Updated
November 15, 2022
Results First Posted
October 1, 2015
Record last verified: 2022-11