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

Hyperlipidemia Clinical Trial

— SPIRE-LL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100514
• Other study ID #: B1481045
• Secondary ID: SPIRE-LL2014-000
• Status: Completed
• Phase: Phase 3
• Start date: October 28, 2014
• Est. completion date: July 10, 2017

Study information

• Verified date: July 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: July 10, 2017
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection for 52 weeks.

Other:
• Placebo
Subcutaneous injection every 2 weeks for 52 weeks.

Locations

Country	Name	City	State
Canada	LMC Clinical Research Inc. (Barrie)	Barrie	Ontario
Canada	Aggarwal And Associates Ltd	Brampton	Ontario
Canada	LMC Clinical Research Inc. (Brampton)	Brampton	Ontario
Canada	Office of Dr. Ronald Collette MD	Burnaby	British Columbia
Canada	LMC Clinical Research Inc. (Calgary)	Calgary	Alberta
Canada	Ecogene-21	Chicoutimi	Quebec
Canada	Corunna Medical Research Centre	Corunna	Ontario
Canada	LMC Clinical Research Inc. (Etobicoke)	Etobicoke	Ontario
Canada	ViaCar Recherche Clinique Inc.	Greenfield Park	Quebec
Canada	Medical Arts Health Research Group	Kamloops	British Columbia
Canada	The Medical Arts Health Research Group	Kelowna	British Columbia
Canada	Glover Medical Clinic	Langley	British Columbia
Canada	Centre de Depistage et de Recherche Cardiovasculaire Rive-Sud	Longueuil	Quebec
Canada	LMC Clinical Research Inc. (Markham)	Markham	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Fraser Clinical Trials	New Westminster	British Columbia
Canada	SKDS Research Inc.	Newmarket	Ontario
Canada	LMC Clinical Research Inc. (Oakville)	Oakville	Ontario
Canada	The Office of Dr. James Cha	Oshawa	Ontario
Canada	The Medical Arts Health Research Group	Penticton	British Columbia
Canada	Kawartha Cardiology Clinical Trials	Peterborough	Ontario
Canada	Alpha Recherche Clinique	Quebec
Canada	Clinique des maladies lipidiques de Quebec	Quebec
Canada	Centre De Sante Et De Services Sociaux De Beauce (CSSSB)	Saint-Georges, Beauce	Quebec
Canada	Scarborough Cardiology Research	Scarborough	Ontario
Canada	LMC Clinical Research Inc. (Thornhill)	Thornhill	Ontario
Canada	LMC Clinical Research Inc. (Bayview)	Toronto	Ontario
Canada	Manna Research Inc.	Toronto	Ontario
Canada	Rouge Valley Health System - Centenary	Toronto	Ontario
Canada	C.I.C. Maurice Inc.	Trois-Rivieres	Quebec
Canada	C.I.C. Mauricie Inc.	Trois-Rivieres	Quebec
Canada	The Office of James K. Lai, MD Inc.	Vancouver	British Columbia
Canada	Cook Street Medical Clinic	Victoria	British Columbia
Czechia	Fakultni nemocnice u sv. Anny Brno. Oddeleni klinicke biochemie	Brno
Czechia	Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy)	Brno
Czechia	Cardiocentrum Kladno s.r.o., Kardiologicka ambulance	Kladno
Czechia	Lekarna - P-P Klinika Kladno	Kladno
Czechia	Lunacor s.r.o.	Kromeriz
Czechia	Fakultni Nemocnice Olomouc, III. interni klinika ¿ nefrologicka, revmatologicka a endokrinologicka	Olomouc
Czechia	Lekarna Domovina	Olomouc
Czechia	Lekarna Fakultni nemocnice Olomouc (pharmacy)	Olomouc
Czechia	PreventaMed, s.r.o.	Olomouc
Czechia	Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika	Praha 10	Vinohrady
Czechia	IKEM, Oddeleni preventivni kardiologie	Praha 4
Czechia	IKEM, Ustavni lekarna	Praha 4
Czechia	BENU lekarna	Pribram
Czechia	Kardiologicka ambulance, III. Poliklinika	Pribram
Czechia	Lekarna 203-02	Slany
Czechia	Nemocnice Slany, Interni oddeleni	Slany
Czechia	AeskuLab k.s., Lipidova poradna	Teplice
Czechia	Lekarna Centrum (pharmacy)	Teplice
Czechia	Dr.Max lekarna	Trutnov
Czechia	Kardiologicka ambulance	Trutnov	Kralovehradecky KRAJ
Finland	Etela-Karjalan Keskussairaala	Lappeenranta
Finland	Turku University Hospital	Turku
Korea, Republic of	Sacred Heart Hospital-Hallym University	Anyang-si	Gyeonggi-do
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Netherlands	St Lucas Andreas Hospital	Amsterdam	North Holland
Netherlands	Gelre Hospitals	Apeldoorn
Netherlands	Andromed Eindhoven	Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Medisch Spectrum Twente	Enschede	ER
Netherlands	Beatrix Hospital	Gorinchem
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	Andro Medical Research B.V.	Rotterdam
Netherlands	Ikazia Hospital	Rotterdam
Netherlands	D&A Research and Genetics	Sneek
Netherlands	St. Elisabeth Hospital	Tilburg
Netherlands	University Medical Center Utrecht	Utrecht
Norway	Ossum Gronert Legetjeneste AS	Honefoss
Norway	Oslo Universitetssykehus HF	Oslo
Norway	Oslo Universitetssykehus HF, Ulleval	Oslo
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia
Poland	MCBK Sc lwona Czajkowska Monika Barney	Grodzisk Mazowiecki
Poland	Clinport Tura Lipinska Dabrowski S.C.	Katowice
Poland	Synexus Polska Sp. z o. o. Oddizial w Katowicach.	Katowice
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Krakow
Poland	Jan Zbigniew Peruga NZOZ SALUS	Lodz
Poland	KO-MED Centra Kliniczne Lublin	Lublin	Lubelskie
Poland	Zespol Opieki Zdrowotnej W Olawie, Oddzial Chorob Wewnetrznych	Olawa
Poland	Synexus Polska Sp. z o.o Oddzial w Poznaniu	Poznan
Poland	KO-MED Centra Kliniczne Sp. z o.o.	Pulawy
Poland	KO-MED. Centra Kliniczne Staszow	Staszow	Swietokrzyskie
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa
Poland	.WroMedica Irena Bielicka, Janusz Szczepanik Spolka Cywlina	Wroclaw
Poland	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw
Poland	KO-MED Centra Kliniczne Zamosc	Zamosc	Lubelskie
Puerto Rico	Cardiometabolic Research Center, Inc	Ponce
Puerto Rico	Ponce School Of Medicine	Ponce
Puerto Rico	Caparra Internal Medicine	Rio Grande
Singapore	National Heart Centre Singapore	Singapore
Singapore	National University Hospital	Singapore
Sweden	Clinical Trial Center (CTC)/Centrum foer klinisk proevning	Goteborg
Sweden	Vardcentralen Lessebo	Lessebo
Sweden	Clinical Trials Consultants AB	Linkoping
Sweden	Capio Citykliniken Hjartmottagning	Lund
Sweden	ProbarE i Lund AB	Lund
Sweden	Dalecarlia Clinical Research Center	Rattvik
Sweden	Citydiabetes	Stockholm
Sweden	Karolinska Universitetssjukhuset Huddinge	Stockholm
United Kingdom	University Hospital Ayr - Nhs Ayrshire And Arran	Ayr
United Kingdom	Synexus Midlands Clinical Research Centre	Birmingham
United Kingdom	Synexus Lancashire Clinical Research Centre	Chorley	Lancashire
United Kingdom	Synexus Scotland Clinical Research Centre	Glasgow	Lanarkshire Scotland
United Kingdom	Synexus North East Clinical Research Centre - Hexham General Hospital	Hexham	Northumberland
United Kingdom	Hull and East Yorkshire Hospitals NHS Trust	Hull
United Kingdom	Synexus Merseyside Clinical Research Centre	Liverpool
United Kingdom	Synexus Manchester Clinical Research Centre	Manchester
United Kingdom	Synexus Thames Valley Clinical Research Centre	Reading	Berkshire
United Kingdom	Salford Royal NHS Foundation Trust	Salford	Greater Manchester
United Kingdom	Abertawe Bro Morgannwg University Local Health Board Joint Clinical Research Facility,	Swansea
United Kingdom	Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital	Worcester	Worcestershire
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Advanced Cardiovascular, LLC Research	Alexander City	Alabama
United States	Millennium Clinical Trials, LLC	Arlington	Virginia
United States	Advanced Cardiovascular, LLC, Research	Auburn	Alabama
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	University of Colorado Hospital	Aurora	Colorado
United States	American Health Network of Indiana, LLC	Avon	Indiana
United States	Bethesda Health Research	Bethesda	Maryland
United States	Boca Raton Clinical Research Associates	Boca Raton	Florida
United States	BRCR Medical Center, Inc.	Boca Raton	Florida
United States	Northwest Clinical Trials, Inc.	Boise	Idaho
United States	Meridien Research	Brooksville	Florida
United States	Punzi Medical Center	Carrollton	Texas
United States	Medical Research South, LLC	Charleston	South Carolina
United States	Clinical Research Advantage, Inc. / Colorado Springs Family Practice	Colorado Springs	Colorado
United States	Ellipsis Research Group, LLC	Columbia	South Carolina
United States	Linfritz Research Institute Inc.	Coral Gables	Florida
United States	Primed Clinical Research	Dayton	Ohio
United States	Creekside Endocrine Associates, PC	Denver	Colorado
United States	Centennial Medical Group	Elkridge	Maryland
United States	McLaren Flint	Flint	Michigan
United States	Florida Health Center	Fort Lauderdale	Florida
United States	Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)	Fremont	Nebraska
United States	Stern Cardiovascular Foundation, Inc	Germantown	Tennessee
United States	Physician's East Endocrinology	Greenville	North Carolina
United States	Physician's East P.A.	Greenville	North Carolina
United States	Physician's East, PA	Greenville	North Carolina
United States	Harleysville Medical Associates	Harleysville	Pennsylvania
United States	Health Care Family Rehab & Research Center	Hialeah	Florida
United States	Indago Research & Health Center, Inc.	Hialeah	Florida
United States	Catawba Valley Medical Group, Inc.	Hickory	North Carolina
United States	Clinical Trials of America, Inc.	Hickory	North Carolina
United States	PMG Research of Hickory	Hickory	North Carolina
United States	Gulf Coast Medical Research,LLC	Houston	Texas
United States	Juno Research, LLC	Houston	Texas
United States	Office of Michelle Zaniewski MD., PA.	Houston	Texas
United States	Apex Cardiology	Jackson	Tennessee
United States	Research Associates of Jackson	Jackson	Tennessee
United States	Juno Research, LLC	Katy	Texas
United States	Clinical Investigation Specialists, Inc.	Kenosha	Wisconsin
United States	PMG Research, Inc d/b/a PMG Research of Knoxville	Knoxville	Tennessee
United States	Imperial Health, LLP	Lake Charles	Louisiana
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	The Office of Larry Watkins, MD	Little Rock	Arkansas
United States	American Institute of Research	Los Angeles	California
United States	IMD Medical Group	Los Angeles	California
United States	lntermed Group	Los Angeles	California
United States	HFM Heart and Vascular Center/Holy Family Memorial, Inc	Manitowoc	Wisconsin
United States	Crescent City Clinical Research Center, LLC	Metairie	Louisiana
United States	Advanced Clinical Research of Miami	Miami	Florida
United States	Columbus Clinical Services, LLC	Miami	Florida
United States	Elite Clinical Research	Miami	Florida
United States	Prestige Clinical Research Center, Inc.	Miami	Florida
United States	Suncoast Research Group, LLD	Miami	Florida
United States	Sunrise Research Institute, Inc	Miami	Florida
United States	The Research Specialists of Florida, Inc.	Miami	Florida
United States	NewPhase Clinical Trials, Corp.	Miami Beach	Florida
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Precision Research Organization	Miami Lakes	Florida
United States	First Quality	Miramar	Florida
United States	Gulf Coast Medical Research, LLC	Missouri City	Texas
United States	Clinical Trials of America LA	Monroe	Louisiana
United States	National Clinical Research-Norfolk, Inc.	Norfolk	Virginia
United States	The Office of Lucita M. Cruz, M.D., Inc.	Norwalk	California
United States	American Family Medical	Ocala	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	South Oklahoma Heart Research, LLC	Oklahoma City	Oklahoma
United States	Aspen Clinical Research	Orem	Utah
United States	Andres Patron, D.O.P.A.	Pembroke Pines	Florida
United States	DBC Research USA	Pembroke Pines	Florida
United States	Pines Care Research Center, LLC	Pembroke Pines	Florida
United States	Office of Daniel G. Williams, MD	Perrysburg	Ohio
United States	Clinical Research Advantage, Inc./Family Practice Specialists, LTD	Phoenix	Arizona
United States	Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.	Phoenix	Arizona
United States	Riser Medical Research	Picayune	Mississippi
United States	Clinical Research Advantage, Inc./ Plano Internal Medicine Associates	Plano	Texas
United States	Accord Clinical Research, Llc	Port Orange	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Sound Health Care Center	Port Orchard	Washington
United States	Sound Medical Research	Port Orchard	Washington
United States	ActivMed Practices & Research, Inc.	Portsmouth	New Hampshire
United States	Wake Internal Medicine Consultants, Inc.	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Superior Research ,LLC	Sacramento	California
United States	Superior Research, LLC	Sacramento	California
United States	East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute	Saint Augustine	Florida
United States	East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research	Saint Augustine	Florida
United States	CentraCare Heart & Vascular Center @ St. Cloud Hospital	Saint Cloud	Minnesota
United States	CentraCare Heart & Vascular Center at St. Cloud Hospital	Saint Cloud	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Washington University, The Center for Advanced Medicine	Saint Louis	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Radiant Research, Inc.	Santa Rosa	California
United States	Cardiovascular Center of Sarasota	Sarasota	Florida
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Gulf Coast Medical Research, LLC	Sugar Land	Texas
United States	Meridien Research	Tampa	Florida
United States	Radiant Research, Inc	Tucson	Arizona
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Castlerock Clinical Research Consultants,LLC	Tulsa	Oklahoma
United States	Orange County Research Center	Tustin	California
United States	Ventura Clinical Trials	Ventura	California
United States	Walla Walla Clinic	Walla Walla	Washington
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Northwest Family Physicians	Wichita	Kansas
United States	Berks Cardiologists, Ltd.	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Finland,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Puerto Rico,  Singapore,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12		Baseline, Week 12
Secondary	Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	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
Secondary	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
Secondary	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
Secondary	Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period		Baseline, Week 24, 52
Secondary	Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	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
Secondary	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
Secondary	Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12		Baseline, Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Plasma Concentration Versus Time Summary of PF-04950615		Week 12, 24, 52
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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