Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy (ODYSSEY FH I)

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

• To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
• To evaluate the effects of alirocumab on other lipid parameters
• To evaluate the safety and tolerability of alirocumab

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Placebo (for alirocumab); Drug: Lipid Modifying Therapy (LMT); Drug: Alirocumab

Detailed Description

The maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (LTS13463, NCT01954394) at the end of the treatment period.

• Study Type: Interventional
• Enrollment (Actual): 486
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Investigational Site Number 040403
  • Wien, Austria, 1130
    • Investigational Site Number 040402
  • Wien, Austria
    • Investigational Site Number 040405
• Canada
  • Chicoutimi, Canada, G7H 5H6
    • Investigational Site Number 124404
  • Montreal, Canada, H2W 1R7
    • Investigational Site Number 124401
  • Quebec, Canada, G1V 4M6
    • Investigational Site Number 124403
  • Sherbrooke, Canada, J1H 5N4
    • Investigational Site Number 124406
  • Toronto, Canada, M5C 2T2
    • Investigational Site Number 124407
• Czech Republic
  • Praha, Czech Republic, 140 00
    • Investigational Site Number 203401
  • Praha, Czech Republic, 180 00
    • Investigational Site Number 203403
  • Uherske Hradiste, Czech Republic
    • Investigational Site Number 203405
  • Zlin, Czech Republic, 760 00
    • Investigational Site Number 203402
• Denmark
  • Copenhagen, Denmark
    • Investigational Site Number 208401
  • Esbjerg, Denmark, 6700
    • Investigational Site Number 208403
• France
  • Dijon, France, 21000
    • Investigational Site Number 250403
  • Paris Cedex 13, France, 75651
    • Investigational Site Number 250401
  • Saint Herblain, France, 44093
    • Investigational Site Number 250402
• Israel
  • Holon, Israel, 76100
    • Investigational Site Number 376402
  • Jerusalem, Israel
    • Investigational Site Number 376405
  • Safed, Israel, 13100
    • Investigational Site Number 376404
  • Tel Hashomer, Israel, 52621
    • Investigational Site Number 376401
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Investigational Site Number 528406
  • Amsterdam, Netherlands
    • Investigational Site Number 528410
  • Den Helder, Netherlands, 1782 GZ
    • Investigational Site Number 528408
  • Groningen, Netherlands, 9728 NT
    • Investigational Site Number 528402
  • Leiden, Netherlands, 2333 ZA
    • Investigational Site Number 528411
  • Maastricht, Netherlands, 6229 HX
    • Investigational Site Number 528416
  • Nieuwegein, Netherlands, 3435 CM
    • Investigational Site Number 528409
  • Sliedrecht, Netherlands
    • Investigational Site Number 528412
• Norway
  • Bodø, Norway, 8092
    • Investigational Site Number 578401
• Russian Federation
  • Arkhangelsk, Russian Federation, 163000
    • Investigational Site Number 643402
  • Kazan, Russian Federation, 420012
    • Investigational Site Number 643407
  • Moscow, Russian Federation, 111539
    • Investigational Site Number 643409
  • Moscow, Russian Federation, 121552
    • Investigational Site Number 643413
  • Moscow, Russian Federation, 129301
    • Investigational Site Number 643401
  • Novisibirsk, Russian Federation
    • Investigational Site Number 643412
  • St-Petersburg, Russian Federation, 193079
    • Investigational Site Number 643408
  • St-Petersburg, Russian Federation, 194291
    • Investigational Site Number 643406
  • St-Petersburg, Russian Federation, 197341
    • Investigational Site Number 643404
  • Yaroslavl, Russian Federation, 150062
    • Investigational Site Number 643410
• South Africa
  • Bloemfontein, South Africa
    • Investigational Site Number 710401
  • Bloemfontein, South Africa
    • Investigational Site Number 710405
  • Cap Town, South Africa, 7530
    • Investigational Site Number 710406
  • Cape Town, South Africa, 7708
    • Investigational Site Number 710402
  • Parktown, South Africa, 2193
    • Investigational Site Number 710407
  • Parow, South Africa, 7500
    • Investigational Site Number 710403
  • Pretoria, South Africa
    • Investigational Site Number 710408
  • Rondebosch, South Africa
    • Investigational Site Number 710404
  • Somerset West, South Africa, 7130
    • Investigational Site Number 710409
• Spain
  • A Coruna, Spain, 15006
    • Investigational Site Number 724403
  • Barcelona, Spain, 08036
    • Investigational Site Number 724408
  • Córdoba, Spain, 14004
    • Investigational Site Number 724406
  • Hospitalet De Llobregat, Spain, 08907
    • Investigational Site Number 724407
  • Madrid, Spain, 28029
    • Investigational Site Number 724409
  • Madrid, Spain, 28040
    • Investigational Site Number 724401
  • Madrid, Spain, 28040
    • Investigational Site Number 724405
  • Reus, Spain, 43201
    • Investigational Site Number 724404
  • Zaragoza, Spain, 50009
    • Investigational Site Number 724402
• Sweden
  • Goteborg, Sweden, 41345
    • Investigational Site Number 752404
  • Stockholm, Sweden, 111 35
    • Investigational Site Number 752401
• United Kingdom
  • London, United Kingdom
    • Investigational Site Number 826402
  • London, United Kingdom
    • Investigational Site Number 826403
  • London, United Kingdom
    • Investigational Site Number 826408
  • London, United Kingdom
    • Investigational Site Number 826409
  • Manchester, United Kingdom, M23 9LT
    • Investigational Site Number 826405
• United States
  • California
    • Bell Gardens, California, United States, 90201
      • Investigational Site Number 840417
    • Long Beach, California, United States, 90801
      • Investigational Site Number 840429
    • Los Angeles, California, United States, 90048
      • Investigational Site Number 840419
    • Mission Viejo, California, United States, 92691
      • Investigational Site Number 840421
    • Newport Beach, California, United States, 92660
      • Investigational Site Number 840412
    • Newport Beach, California, United States
      • Investigational Site Number 840428
    • Northridge, California, United States, 91324
      • Investigational Site Number 840461
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Investigational Site Number 840452
  • Florida
    • Miami, Florida, United States, 33165
      • Investigational Site Number 840456
    • Ponte Vedra, Florida, United States, 32081
      • Investigational Site Number 840418
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Investigational Site Number 840455
  • Kansas
    • Kansas City, Kansas, United States, 66160-7321
      • Investigational Site Number 840415
  • Maine
    • Auburn, Maine, United States, 04210
      • Investigational Site Number 840425
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Investigational Site Number 840411
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Investigational Site Number 840409
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Investigational Site Number 840407
  • New York
    • New York, New York, United States, 10032
      • Investigational Site Number 840408
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Investigational Site Number 840401
    • Durham, North Carolina, United States, 27710
      • Investigational Site Number 840410
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Investigational Site Number 840430
  • Oregon
    • Portland, Oregon, United States, 97201-3098
      • Investigational Site Number 840424
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Investigational Site Number 840404
    • Philadelphia, Pennsylvania, United States, 19104
      • Investigational Site Number 840426
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Investigational Site Number 840406
  • Texas
    • Dallas, Texas, United States, 75216
      • Investigational Site Number 840460
  • Utah
    • Bountiful, Utah, United States, 84010
      • Investigational Site Number 840422

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:

• Participants with heterozygous familial hypercholesterolemia who were not adequately controlled with their lipid-modifying therapy

Exclusion criteria:

• Age < 18 years or legal age of adulthood, whichever is greater
• LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
• LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
• Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L)
• Known history of homozygous familial hypercholesterolemia

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo for alirocumab every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.	Drug: Placebo (for alirocumab); Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).; Drug: Lipid Modifying Therapy (LMT); Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Experimental: Alirocumab 75 mg/Up to 150 mg Q2W; Alirocumab 75 mg Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.	Drug: Lipid Modifying Therapy (LMT); Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.; Drug: Alirocumab; Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).; Other Names: SAR236553; REGN727; Praluent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis	Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).	From Baseline to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis	Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis	Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).	From Baseline to Week 52
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis	Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).	From Baseline to Week 52
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis	Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis	Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis	Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis	Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis	Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis	Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis	Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).	From Baseline to Week 52
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis	Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis	Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).	From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis	Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis	Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis	Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.	From Baseline to Week 52
Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis	Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.	Up to Week 52
Percentage of Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - On- Treatment Analysis	Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.	Up to Week 52
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis	Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	Up to Week 52
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis	Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.	Up to Week 52
Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis	Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis	Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis	Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis	Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis	Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.	From Baseline to Week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis	Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).	From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis	Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).	From Baseline to Week 78
Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis	Adjusted LS means and standard errors at Week 78 from MMRM including all available post-baseline data from Week 4 to Week 78 regardless of status on-or off-treatment.	From Baseline to Week 78

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• Kastelein JJ, Robinson JG, Farnier M, Krempf M, Langslet G, Lorenzato C, Gipe DA, Baccara-Dinet MT. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy: design and rationale of the ODYSSEY FH studies. Cardiovasc Drugs Ther. 2014 Jun;28(3):281-9. doi: 10.1007/s10557-014-6523-z.
• Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.
• Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.
• Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4. Erratum In: J Clin Lipidol. 2020 Sep - Oct;14(5):742.
• Kastelein JJ, Hovingh GK, Langslet G, Baccara-Dinet MT, Gipe DA, Chaudhari U, Zhao J, Minini P, Farnier M. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Jan-Feb;11(1):195-203.e4. doi: 10.1016/j.jacl.2016.12.004. Epub 2016 Dec 28.
• Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.
• Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015 Nov 14;36(43):2996-3003. doi: 10.1093/eurheartj/ehv370. Epub 2015 Sep 1.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 15, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Estimate): February 8, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: PCSK9
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hypercholesterolemia; Hyperlipoproteinemia Type II; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: EFC12492; U1111-1121-4275 (Other Identifier: UTN); 2011-005109-56 (EudraCT Number)