Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events (SPIRE-LL)

A 52 Week Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: Bococizumab (PF-04950615; RN316); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 746
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G3K 2P8
    • ALPHA Recherche Clinique
  • Quebec, Canada, G1V 4W2
    • Clinique des maladies lipidiques de Quebec
  • Alberta
    • Calgary, Alberta, Canada, T2H 2G4
      • LMC Clinical Research Inc. (Calgary)
  • British Columbia
    • Burnaby, British Columbia, Canada, V5G 1T4
      • Office of Dr. Ronald Collette MD
    • Kamloops, British Columbia, Canada, V2C 1K7
      • Medical Arts Health Research Group
    • Kelowna, British Columbia, Canada, V1Y 1V6
      • The Medical Arts Health Research Group
    • Langley, British Columbia, Canada, V3A 4H9
      • Glover Medical Clinic
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Fraser Clinical Trials
    • Penticton, British Columbia, Canada, V2A 5C8
      • The Medical Arts Health Research Group
    • Vancouver, British Columbia, Canada, V5Z 1K3
      • The Office of James K. Lai, MD Inc.
    • Victoria, British Columbia, Canada, V8V 4A1
      • Cook Street Medical Clinic
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • LMC Clinical Research Inc. (Barrie)
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Ltd
    • Brampton, Ontario, Canada, L6S 0C9
      • LMC Clinical Research Inc. (Brampton)
    • Corunna, Ontario, Canada, N0N 1G0
      • Corunna Medical Research Centre
    • Etobicoke, Ontario, Canada, M9R 4E1
      • LMC Clinical Research Inc. (Etobicoke)
    • Markham, Ontario, Canada, L6B 0P9
      • LMC Clinical Research Inc. (Markham)
    • Newmarket, Ontario, Canada, L3Y 5G8
      • SKDS Research Inc.
    • Oakville, Ontario, Canada, L6M 1M1
      • LMC Clinical Research Inc. (Oakville)
    • Oshawa, Ontario, Canada, L1J 2K1
      • The Office of Dr. James Cha
    • Peterborough, Ontario, Canada, K9J 0B2
      • Kawartha Cardiology Clinical Trials
    • Scarborough, Ontario, Canada, M1E 5E9
      • Scarborough Cardiology Research
    • Thornhill, Ontario, Canada, L4J 8L7
      • LMC Clinical Research Inc. (Thornhill)
    • Toronto, Ontario, Canada, M4G 3E8
      • LMC Clinical Research Inc. (Bayview)
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research Inc.
    • Toronto, Ontario, Canada, M1E 4B9
      • Rouge Valley Health System - Centenary
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Ecogene-21
    • Greenfield Park, Quebec, Canada, J4V 2G8
      • Viacar Recherche Clinique Inc.
    • Longueuil, Quebec, Canada, J4M2X1
      • Centre de Depistage et de Recherche Cardiovasculaire Rive-Sud
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Saint-Georges, Beauce, Quebec, Canada, G5Y 4T8
      • Centre De Sante Et De Services Sociaux De Beauce (CSSSB)
    • Trois-Rivieres, Quebec, Canada, G8T 7A1
      • C.I.C. Mauricie inc.
    • Trois-Rivieres, Quebec, Canada, G8T 7A1
      • C.I.C. Maurice Inc.
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny Brno. Oddeleni klinicke biochemie
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy)
  • Kladno, Czechia, 27280
    • Cardiocentrum Kladno s.r.o., Kardiologicka ambulance
  • Kladno, Czechia, 27280
    • Lekarna - P-P Klinika Kladno
  • Kromeriz, Czechia, 76701
    • Lunacor s.r.o.
  • Olomouc, Czechia, 779 00
    • PreventaMed, s.r.o.
  • Olomouc, Czechia, 775 20
    • Fakultni Nemocnice Olomouc, III. interni klinika ¿ nefrologicka, revmatologicka a endokrinologicka
  • Olomouc, Czechia, 77520
    • Lekarna Fakultni nemocnice Olomouc (pharmacy)
  • Olomouc, Czechia, 779 00
    • Lekarna Domovina
  • Praha 4, Czechia, 140 21
    • IKEM, Ustavni lekarna
  • Praha 4, Czechia, 140 21
    • IKEM, Oddeleni preventivni kardiologie
  • Pribram, Czechia, 261 01
    • BENU Lekarna
  • Pribram, Czechia, 261 01
    • Kardiologicka ambulance, III. Poliklinika
  • Slany, Czechia, 274 01
    • Nemocnice Slany, interni oddeleni
  • Slany, Czechia, 274 01
    • Lekarna 203-02
  • Teplice, Czechia, 415 01
    • AeskuLab k.s., Lipidova poradna
  • Teplice, Czechia, 415 01
    • Lekarna Centrum (pharmacy)
  • Trutnov, Czechia, 541 01
    • Dr.Max lekarna
  • Kralovehradecky KRAJ
    • Trutnov, Kralovehradecky KRAJ, Czechia, 54101
      • Kardiologicka ambulance
  • Vinohrady
    • Praha 10, Vinohrady, Czechia, 100 34
      • Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika
• Finland
  • Lappeenranta, Finland, 53130
    • Etela-Karjalan Keskussairaala
  • Turku, Finland, 20520
    • Turku University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, Korea, Republic of, 431-796
      • Sacred Heart Hospital-Hallym University
    • Guri-si, Gyeonggi-do, Korea, Republic of, 11923
      • Hanyang University Guri Hospital
• Netherlands
  • Apeldoorn, Netherlands, 7334 DZ
    • Gelre Hospitals
  • Eindhoven, Netherlands, 5611 NV
    • Andromed Eindhoven
  • Enschede, Netherlands, 7513 ER
    • Medisch Spectrum Twente
  • Gorinchem, Netherlands, 4204 AA
    • Beatrix Hospital
  • Groningen, Netherlands, 9728 NT
    • Martini Ziekenhuis
  • Heerlen, Netherlands, 6419 PC
    • Zuyderland Medisch Centrum
  • Rotterdam, Netherlands, 3083AN
    • Ikazia Hospital
  • Rotterdam, Netherlands, 3021 HC
    • Andro Medical Research B.V.
  • Sneek, Netherlands, 8601 ZR
    • D&A Research and Genetics
  • Tilburg, Netherlands, 5022 GC
    • St. Elisabeth Hospital
  • Utrecht, Netherlands, 3584 CX
    • University Medical Center Utrecht
  • ER
    • Enschede, ER, Netherlands, 7513
      • Medisch Spectrum Twente
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1061 AE
      • St Lucas Andreas Hospital
• Norway
  • Honefoss, Norway, 3515
    • Ossum Gronert Legetjeneste AS
  • Oslo, Norway, 0373
    • Oslo Universitetssykehus HF
  • Oslo, Norway, 0424
    • Oslo Universitetssykehus HF, Ulleval
• Poland
  • Gdynia, Poland, 81-384
    • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Grodzisk Mazowiecki, Poland, 05-825
    • MCBK Sc lwona Czajkowska Monika Barney
  • Katowice, Poland, 40-040
    • Synexus Polska Sp. z o. o. Oddizial w Katowicach.
  • Katowice, Poland, 40-084
    • Clinport Tura Lipinska Dabrowski S.C.
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im. Jana Pawla II
  • Lodz, Poland, 91-302
    • Jan Zbigniew Peruga NZOZ SALUS
  • Olawa, Poland, 55-200
    • Zespol Opieki Zdrowotnej W Olawie, Oddzial Chorob Wewnetrznych
  • Poznan, Poland, 60-702
    • Synexus Polska Sp. z o.o Oddzial w Poznaniu
  • Pulawy, Poland, 24-100
    • KO-MED Centra Kliniczne Sp. z o.o.
  • Warszawa, Poland, 01-192
    • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Wroclaw, Poland, 50-088
    • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • Wroclaw, Poland, 51-685
    • .WroMedica Irena Bielicka, Janusz Szczepanik Spolka Cywlina
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-362
      • KO-MED Centra Kliniczne LUBLIN
    • Zamosc, Lubelskie, Poland, 22-400
      • KO-MED Centra Kliniczne Zamosc
  • Swietokrzyskie
    • Staszow, Swietokrzyskie, Poland, 28-200
      • KO-MED. Centra Kliniczne Staszow
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine
  • Ponce, Puerto Rico, 00717
    • Cardiometabolic Research Center, Inc
  • Rio Grande, Puerto Rico, 00745
    • Caparra Internal Medicine
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital
  • Singapore, Singapore, 169609
    • National Heart Centre Singapore
• Sweden
  • Goteborg, Sweden, 413 45
    • Clinical Trial Center (CTC)/Centrum foer klinisk proevning
  • Lessebo, Sweden, 360 50
    • Vardcentralen Lessebo
  • Linkoping, Sweden, 58758
    • Clinical Trials Consultants AB
  • Lund, Sweden, 222 22
    • ProbarE i Lund AB
  • Lund, Sweden, 22221
    • Capio Citykliniken Hjartmottagning
  • Rattvik, Sweden, 79530
    • Dalecarlia Clinical Research Center
  • Stockholm, Sweden, 141 86
    • Karolinska Universitetssjukhuset Huddinge
  • Stockholm, Sweden, 111 57
    • Citydiabetes
• United Kingdom
  • Ayr, United Kingdom, KA6 6DX
    • University Hospital Ayr - Nhs Ayrshire And Arran
  • Birmingham, United Kingdom, B15 2SQ
    • Synexus Midlands Clinical Research Centre
  • Hull, United Kingdom, HU3 2JZ
    • Hull and East Yorkshire Hospitals NHS Trust
  • Liverpool, United Kingdom, L22 0LG
    • Synexus Merseyside Clinical Research Centre
  • Manchester, United Kingdom, M15 6SX
    • Synexus Manchester Clinical Research Centre
  • Swansea, United Kingdom, SA2 8PP
    • Abertawe Bro Morgannwg University Local Health Board Joint Clinical Research Facility,
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG2 0TG
      • Synexus Thames Valley Clinical Research Centre
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Salford Royal NHS Foundation Trust
  • Lanarkshire Scotland
    • Glasgow, Lanarkshire Scotland, United Kingdom, G20 0SP
      • Synexus Scotland Clinical Research Centre
  • Lancashire
    • Chorley, Lancashire, United Kingdom, PR7 7NA
      • Synexus Lancashire Clinical Research Centre
  • Northumberland
    • Hexham, Northumberland, United Kingdom, NE46 1QJ
      • Synexus North East Clinical Research Centre - Hexham General Hospital
  • Worcestershire
    • Worcester, Worcestershire, United Kingdom, WR5 1DD
      • Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
• United States
  • Alabama
    • Alexander City, Alabama, United States, 35010
      • Advanced Cardiovascular, LLC Research
    • Auburn, Alabama, United States, 36830
      • Advanced Cardiovascular, LLC, Research
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.
    • Phoenix, Arizona, United States, 85018
      • Clinical Research Advantage, Inc./Family Practice Specialists, LTD
    • Tucson, Arizona, United States, 85712
      • Radiant Research, Inc.
    • Tucson, Arizona, United States, 85712
      • Radiant Research, Inc
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
    • Little Rock, Arkansas, United States, 72205
      • The Office of Larry Watkins, MD
  • California
    • Los Angeles, California, United States, 90017
      • American Institute of Research
    • Los Angeles, California, United States, 90020
      • IMD Medical Group
    • Los Angeles, California, United States, 90017
      • lntermed Group
    • Norwalk, California, United States, 90650
      • The Office of Lucita M. Cruz, M.D., Inc.
    • Sacramento, California, United States, 95825
      • Superior Research, LLC
    • Sacramento, California, United States, 95831
      • Superior Research ,LLC
    • Santa Rosa, California, United States, 95405
      • Radiant Research, Inc.
    • Tustin, California, United States, 92780
      • Orange County Research Center
    • Ventura, California, United States, 93003
      • Ventura Clinical Trials
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Colorado Springs, Colorado, United States, 80909
      • Clinical Research Advantage, Inc. / Colorado Springs Family Practice
    • Denver, Colorado, United States, 80209
      • Creekside Endocrine Associates, PC
  • Florida
    • Boca Raton, Florida, United States, 33432
      • Boca Raton Clinical Research Associates
    • Boca Raton, Florida, United States, 33432
      • BRCR Medical Center, Inc.
    • Brooksville, Florida, United States, 34601
      • Meridien Research
    • Coral Gables, Florida, United States, 33134
      • Linfritz Research Institute Inc.
    • Fort Lauderdale, Florida, United States, 33312
      • Florida Health Center
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc.
    • Hialeah, Florida, United States, 33012
      • Health Care Family Rehab & Research Center
    • Miami, Florida, United States, 33144
      • Elite Clinical Research
    • Miami, Florida, United States, 33130
      • Sunrise Research Institute, Inc
    • Miami, Florida, United States, 33133
      • Prestige Clinical Research Center, Inc.
    • Miami, Florida, United States, 33155
      • Advanced Clinical Research of Miami
    • Miami, Florida, United States, 33135
      • Suncoast Research Group, LLD
    • Miami, Florida, United States, 33162
      • The Research Specialists of Florida, Inc.
    • Miami, Florida, United States, 33165
      • Columbus Clinical Services, LLC
    • Miami Beach, Florida, United States, 33140
      • NewPhase Clinical Trials, Corp.
    • Miami Lakes, Florida, United States, 33014
      • Panax Clinical Research
    • Miami Lakes, Florida, United States, 33016
      • Precision Research Organization
    • Miramar, Florida, United States, 33025
      • First Quality
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocala, Florida, United States, 34471
      • American Family Medical
    • Pembroke Pines, Florida, United States, 33026
      • Pines Care Research Center, LLC
    • Pembroke Pines, Florida, United States, 33029
      • DBC Research USA
    • Pembroke Pines, Florida, United States, 33026
      • Andres Patron, D.O.P.A.
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Saint Augustine, Florida, United States, 32086
      • East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute
    • Saint Augustine, Florida, United States, 32086
      • East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
    • Sarasota, Florida, United States, 34239
      • Cardiovascular Center of Sarasota
    • Tampa, Florida, United States, 33634
      • Meridien Research
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials, Inc.
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network of Indiana, LLC
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67205
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67205
      • Northwest Family Physicians
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Imperial Health, LLP
    • Metairie, Louisiana, United States, 70006
      • Crescent City Clinical Research Center, LLC
    • Monroe, Louisiana, United States, 71201
      • Clinical Trials of America LA
  • Maryland
    • Bethesda, Maryland, United States, 208174
      • Bethesda Health Research
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group
  • Michigan
    • Flint, Michigan, United States, 48532
      • McLaren Flint
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart & Vascular Center @ St. Cloud Hospital
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart & Vascular Center at St. Cloud Hospital
  • Mississippi
    • Picayune, Mississippi, United States, 39466
      • Riser Medical Research
  • Missouri
    • Saint Louis, Missouri, United States
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • Washington University, The Center for Advanced Medicine
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices & Research, Inc.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physician's East Endocrinology
    • Greenville, North Carolina, United States, 27834
      • Physician's East, PA
    • Greenville, North Carolina, United States, 27834
      • Physician's East P.A.
    • Hickory, North Carolina, United States, 28601
      • Clinical Trials of America, Inc.
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory
    • Hickory, North Carolina, United States, 28601
      • Catawba Valley Medical Group, Inc.
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Raleigh, North Carolina, United States, 27612
      • Wake Internal Medicine Consultants, Inc.
  • Ohio
    • Dayton, Ohio, United States, 45419
      • PriMed Clinical Research
    • Perrysburg, Ohio, United States, 43551
      • Office of Daniel G. Williams, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • South Oklahoma Heart Research, LLC
    • Tulsa, Oklahoma, United States, 74136
      • Castlerock Clinical Research Consultants,LLC
  • Pennsylvania
    • Harleysville, Pennsylvania, United States, 19438
      • Harleysville Medical Associates
    • Wyomissing, Pennsylvania, United States, 19610
      • Berks Cardiologists, Ltd.
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Medical Research South, LLC
    • Columbia, South Carolina, United States, 29204
      • Ellipsis Research Group, LLC
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular Foundation, Inc
    • Jackson, Tennessee, United States, 38301
      • Research Associates Of Jackson
    • Jackson, Tennessee, United States, 38301
      • Apex Cardiology
    • Knoxville, Tennessee, United States, 37912
      • PMG Research, Inc d/b/a PMG Research of Knoxville
  • Texas
    • Carrollton, Texas, United States, 75006
      • Punzi Medical Center
    • Houston, Texas, United States, 77036
      • Juno Research, LLC
    • Houston, Texas, United States, 77090
      • Office of Michelle Zaniewski MD., PA.
    • Houston, Texas, United States, 77081
      • Gulf Coast Medical Research,LLC
    • Katy, Texas, United States, 77450
      • Juno Research, LLC
    • Missouri City, Texas, United States, 77459
      • Gulf Coast Medical Research, LLC
    • Plano, Texas, United States, 75093
      • Clinical Research Advantage, Inc./ Plano Internal Medicine Associates
    • San Antonio, Texas, United States, 78205
      • Clinical Trials of Texas, Inc.
    • Sugar Land, Texas, United States, 77478
      • Gulf Coast Medical Research, LLC
  • Utah
    • Orem, Utah, United States, 84058
      • Aspen Clinical Research
  • Virginia
    • Arlington, Virginia, United States, 22207
      • Millennium Clinical Trials, LLC
    • Norfolk, Virginia, United States, 23502
      • National Clinical Research-Norfolk, Inc.
  • Washington
    • Port Orchard, Washington, United States, 98366
      • Sound Medical Research
    • Port Orchard, Washington, United States, 98366
      • Sound Health Care Center
    • Walla Walla, Washington, United States, 99362
      • Walla Walla Clinic
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Clinical Investigation Specialists, Inc.
    • Manitowoc, Wisconsin, United States, 54220
      • HFM Heart and Vascular Center/Holy Family Memorial, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Treated with a statin
• Fasting LDL-C >=100 mg/dL and triglyceride <= 400 mg/dL
• High or very high risk of incurring a cardiovascular event

Exclusion Criteria:

• Pregnant or breastfeeding females
• Cardiovascular or cerebrovascular event or procedure within 90 days
• Congestive heart failure NYHA class IV
• Poorly controlled hypertension

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: Placebo; Subcutaneous injection every 2 weeks for 52 weeks.
Experimental: Bococizumab (PF-04950615; RN316)	Drug: Bococizumab (PF-04950615; RN316); 150 mg every 2 weeks, subcutaneous injection for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period		Baseline, Week 24, 52
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12		Baseline, Week 12
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12		Baseline, Week 12
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12		Baseline, Week 12
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12		Baseline, Week 12
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12		Baseline, Week 12
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12		Baseline, Week 12
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52		Week 12, 24, 52
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52		Week 12, 24, 52
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12		Baseline, Week 12
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12		Baseline, Week 12
Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Plasma Concentration Versus Time Summary of PF-04950615		Week 12, 24, 52
Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions	Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.	Baseline up to end of study (up to 110 weeks)
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period	Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log 2) unit was considered to be ADA positive and nAb titer >=1.58 (log 2) unit was considered to be nAb positive.	Baseline up to Week 58
Number of Participants Who Changed Concomitant Medication During Extension Period	In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.	Week 58 follow-up to Week 110
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period		Baseline, Week 58 (follow up), 71, 84, 97, 110
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period	Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 log2 unit was considered to be ADA positive and nAb titer >=1.58 log2 unit was considered to be nAb positive.	Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Chasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5.
• Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul-Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.
• Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2014
• Primary Completion (Actual): July 15, 2016
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: March 27, 2014
• First Posted (Estimate): April 1, 2014

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: high risk of cardiovascular events; Primary hyperlipidemia or mixed dyslipidemia; multiple cardiovascular disease risk factors.
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Bococizumab
• Other Study ID Numbers: B1481045; SPIRE-LL (Other Identifier: Alias Study Number); 2014-000478-20 (EudraCT Number)