GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)

A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Placebo; Biological: Evolocumab

• Study Type: Interventional
• Enrollment (Actual): 970
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Research Site
  • Corrientes, Argentina, W3400AMZ
    • Research Site
  • Córdoba, Argentina, X5003DCE
    • Research Site
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
      • Research Site
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1428DCO
      • Research Site
    • La Plata, Buenos Aires, Argentina, 1900
      • Research Site
  • Córdoba
    • Cordoba, Córdoba, Argentina, X5016KEH
      • Research Site
    • Cordoba, Córdoba, Argentina, X5000JHQ
      • Research Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Research Site
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Research Site
    • Darlinghurst, New South Wales, Australia, 2010
      • Research Site
    • Liverpool, New South Wales, Australia, 2170
      • Research Site
    • New Lambton Heights, New South Wales, Australia, 2305
      • Research Site
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Research Site
    • Herston, Queensland, Australia, 4029
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  • South Australia
    • Adelaide, South Australia, Australia, 5000
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    • Bedford Park, South Australia, Australia, 5042
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  • Victoria
    • Epping, Victoria, Australia, 3076
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    • Footscray, Victoria, Australia, 3011
      • Research Site
    • Heidelberg, Victoria, Australia, 3084
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    • Melbourne, Victoria, Australia, 3004
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  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
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• Belgium
  • Antwerpen, Belgium, 2020
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  • Brussels, Belgium, 1090
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  • Bruxelles, Belgium, 1200
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  • Edegem, Belgium, 2650
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  • Genk, Belgium, 3600
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  • Gent, Belgium, 9000
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  • Hasselt, Belgium, 3500
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  • Lodelinsart, Belgium, 6042
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• Brazil
  • São Paulo, Brazil, 05403-000
    • Research Site
  • Espírito Santo
    • Cariacica, Espírito Santo, Brazil, 29156-580
      • Research Site
  • Goiás
    • Goiania, Goiás, Brazil, 74223-130
      • Research Site
  • Paraná
    • Curitiba, Paraná, Brazil, 80320-320
      • Research Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Research Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
      • Research Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001
      • Research Site
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 04012-909
      • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Research Site
    • Edmonton, Alberta, Canada, T6G 2B7
      • Research Site
    • Edmonton, Alberta, Canada, T5H 3V9
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  • British Columbia
    • Victoria, British Columbia, Canada, V8R 4R2
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  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
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  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
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  • Newfoundland and Labrador
    • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
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  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
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  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Research Site
    • Toronto, Ontario, Canada, M5G 2C4
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    • Toronto, Ontario, Canada, M5B 1W8
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  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
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    • Montreal, Quebec, Canada, H4J 1C5
      • Research Site
    • Montreal, Quebec, Canada, H1T 2M4
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    • Montreal, Quebec, Canada, H3A 1A1
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    • Quebec City, Quebec, Canada, G1V 4G5
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• Chile
  • Santiago, Chile, 8207257
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  • Santiago, Chile, 7650018
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  • Santiago, Chile, 8330032
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  • Cautín
    • Temuco, Cautín, Chile, 4781156
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• Czechia
  • Brno, Czechia, 625 00
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  • Hradec Kralove, Czechia, 500 05
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  • Praha 2, Czechia, 128 08
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  • Praha 4, Czechia, 140 21
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  • Usti nad Labem, Czechia, 401 13
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  • Zlin, Czechia, 762 75
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• Denmark
  • Aarhus N, Denmark, 8200
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  • Odense C, Denmark, 5000
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• France
  • Besançon Cedex, France, 25030
    • Research Site
  • Chambray les Tours, France, 37170
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  • Creteil, France, 94010
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  • Marseille cedex 5, France, 13385
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  • Paris, France, 75015
    • Research Site
  • Pessac Cedex, France, 33604
    • Research Site
• Germany
  • Aachen, Germany, 52074
    • Research Site
  • Essen, Germany, 45122
    • Research Site
  • München, Germany, 81737
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  • Neuss, Germany, 41464
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  • Regensburg, Germany, 93053
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  • Ulm, Germany, 89081
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• Greece
  • Alexandroupoli, Greece, 68100
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  • Athens, Greece, 11527
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  • Athens, Greece, 14561
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  • Athens, Greece, 17674
    • Research Site
  • Heraklion, Greece, 71110
    • Research Site
• Hungary
  • Budapest, Hungary, 1122
    • Research Site
  • Budapest, Hungary, 1134
    • Research Site
  • Budapest, Hungary, 1106
    • Research Site
  • Budapest, Hungary, 1023
    • Research Site
  • Debrecen, Hungary, 4032
    • Research Site
  • Pecs, Hungary, 7624
    • Research Site
  • Szeged, Hungary, 6725
    • Research Site
• Iceland
  • Reykjavik, Iceland, 101
    • Research Site
• Ireland
  • Dublin, Ireland, 8
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  • Galway, Ireland
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• Israel
  • Hadera, Israel, 38100
    • Research Site
  • Jerusalem, Israel, 91031
    • Research Site
  • Rehovot, Israel, 76100
    • Research Site
• Italy
  • Novara, Italy, 28100
    • Research Site
  • Roma, Italy, 00168
    • Research Site
  • Rozzano MI, Italy, 20089
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  • Sesto San Giovanni (MI), Italy, 20099
    • Research Site
  • Torino, Italy, 10154
    • Research Site
• Korea, Republic of
  • Daejeon, Korea, Republic of, 301-723
    • Research Site
  • Seongnam-si, Korea, Republic of, 463-707
    • Research Site
  • Seoul, Korea, Republic of, 156-707
    • Research Site
  • Seoul, Korea, Republic of, 130-872
    • Research Site
• Malaysia
  • Penang, Malaysia, 10050
    • Research Site
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Research Site
• Mexico
  • Aguascalientes, Mexico, 20230
    • Research Site
  • Puebla, Mexico, 72490
    • Research Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Research Site
  • Querétaro
    • Queretaro, Querétaro, Mexico, 76000
      • Research Site
  • San Luis Potosí
    • San Luis Potosi, San Luis Potosí, Mexico, 78240
      • Research Site
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80020
      • Research Site
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Research Site
  • Amsterdam, Netherlands, 1081 HV
    • Research Site
  • Amsterdam, Netherlands, 1091 AC
    • Research Site
  • Eindhoven, Netherlands, 5623 EJ
    • Research Site
  • Leeuwarden, Netherlands, 8934 AD
    • Research Site
  • Nieuwegein, Netherlands, 3435 CM
    • Research Site
  • Nijmegen, Netherlands, 6532 SZ
    • Research Site
  • Rotterdam, Netherlands, 3079 DZ
    • Research Site
  • Tilburg, Netherlands, 5042 AD
    • Research Site
  • Utrecht, Netherlands, 3584 CX
    • Research Site
  • Venlo, Netherlands, 5912 BL
    • Research Site
  • Zwolle, Netherlands, 8025 AB
    • Research Site
• Norway
  • Oslo, Norway, 0424
    • Research Site
  • Tromso, Norway, 9038
    • Research Site
• Philippines
  • Pasig City, Philippines, 1600
    • Research Site
  • Quezon City, Philippines, 1100
    • Research Site
  • Quezon City, Philippines, 1102
    • Research Site
• Poland
  • Chrzanow, Poland, 32-500
    • Research Site
  • Kedzierzyn Kozle, Poland, 47-200
    • Research Site
  • Krakow, Poland, 31-501
    • Research Site
  • Krakow, Poland, 31-202
    • Research Site
  • Lodz, Poland, 90-549
    • Research Site
  • Warszawa, Poland, 04-628
    • Research Site
• Russian Federation
  • Kemerovo, Russian Federation, 650002
    • Research Site
  • Moscow, Russian Federation, 101990
    • Research Site
  • Moscow, Russian Federation, 119991
    • Research Site
  • Moscow, Russian Federation, 121552
    • Research Site
• Singapore
  • Singapore, Singapore, 169609
    • Research Site
• South Africa
  • Gauteng
    • Boksburg, Gauteng, South Africa, 1470
      • Research Site
    • Centurion, Gauteng, South Africa, 0157
      • Research Site
    • Johannesburg, Gauteng, South Africa, 2157
      • Research Site
  • Western Cape
    • Kuils River, Western Cape, South Africa, 7580
      • Research Site
    • Pinelands, Cape Town, Western Cape, South Africa, 7405
      • Research Site
    • Somerset West, Western Cape, South Africa, 7130
      • Research Site
• Spain
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Andalucía
    • Malaga, Andalucía, Spain, 29010
      • Research Site
  • Asturias
    • Gijon, Asturias, Spain, 33394
      • Research Site
  • Cataluña
    • Barcelona, Cataluña, Spain, 08035
      • Research Site
    • L Hospitalet De Llobregat, Cataluña, Spain, 08907
      • Research Site
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
      • Research Site
• Sweden
  • Göteborg, Sweden, 413 45
    • Research Site
  • Helsingborg, Sweden, 251 87
    • Research Site
  • Lund, Sweden, 221 85
    • Research Site
  • Solna, Sweden, 171 76
    • Research Site
  • Stockholm, Sweden, 118 83
    • Research Site
  • Örebro, Sweden, 701 85
    • Research Site
• Switzerland
  • Geneva 14, Switzerland, 1211
    • Research Site
  • St. Gallen, Switzerland, 9007
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Research Site
  • New Taipei, Taiwan, 251
    • Research Site
  • Taichung City, Taiwan, 402
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
• United Kingdom
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Research Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Research Site
    • Mobile, Alabama, United States, 36608
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Research Site
  • California
    • La Jolla, California, United States, 92037
      • Research Site
    • La Jolla, California, United States, 92093-0960
      • Research Site
    • Long Beach, California, United States, 90822
      • Research Site
    • Newport Beach, California, United States, 92663
      • Research Site
    • Orange, California, United States, 92868
      • Research Site
    • San Diego, California, United States, 92161
      • Research Site
    • Santa Monica, California, United States, 90404
      • Research Site
    • Torrance, California, United States, 90502
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  • District of Columbia
    • Washington, District of Columbia, United States, 20010
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  • Florida
    • Atlantis, Florida, United States, 33462
      • Research Site
    • Clearwater, Florida, United States, 33756
      • Research Site
    • Jacksonville, Florida, United States, 32209
      • Research Site
    • Jacksonville, Florida, United States, 32216
      • Research Site
    • Melbourne, Florida, United States, 32901
      • Research Site
    • Safety Harbor, Florida, United States, 34695
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Research Site
  • Indiana
    • Hammond, Indiana, United States, 46320
      • Research Site
    • Valparaiso, Indiana, United States, 46383
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Research Site
    • Louisville, Kentucky, United States, 40205
      • Research Site
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Research Site
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Research Site
    • Columbia, Maryland, United States, 21044
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Research Site
    • Bay City, Michigan, United States, 48708
      • Research Site
    • Grand Rapids, Michigan, United States, 49503
      • Research Site
    • Marquette, Michigan, United States, 49855
      • Research Site
    • Midland, Michigan, United States, 48670
      • Research Site
    • Petoskey, Michigan, United States, 49770
      • Research Site
    • Saginaw, Michigan, United States, 48601
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  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Research Site
    • Minneapolis, Minnesota, United States, 55407
      • Research Site
    • Saint Cloud, Minnesota, United States, 56303
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    • Saint Paul, Minnesota, United States, 55102
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  • Missouri
    • Columbia, Missouri, United States, 65212
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  • Montana
    • Missoula, Montana, United States, 59802
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  • Nebraska
    • Omaha, Nebraska, United States, 68198
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  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
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  • New York
    • Buffalo, New York, United States, 14215
      • Research Site
    • Johnson City, New York, United States, 13790
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  • North Carolina
    • Charlotte, North Carolina, United States, 28204
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  • North Dakota
    • Fargo, North Dakota, United States, 58122
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  • Ohio
    • Canton, Ohio, United States, 44710
      • Research Site
    • Elyria, Ohio, United States, 44035
      • Research Site
    • Toledo, Ohio, United States, 43614
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Research Site
    • Tulsa, Oklahoma, United States, 74104
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  • Oregon
    • Hillsboro, Oregon, United States, 97123
      • Research Site
    • Springfield, Oregon, United States, 97477
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  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Research Site
    • Hershey, Pennsylvania, United States, 17033
      • Research Site
  • Tennessee
    • Oak Ridge, Tennessee, United States, 37830
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  • Texas
    • Amarillo, Texas, United States, 79106
      • Research Site
    • Dallas, Texas, United States, 75216
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    • San Antonio, Texas, United States, 78229
      • Research Site
    • Wichita Falls, Texas, United States, 76301
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical indication for coronary angiography
• Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
• Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors

Subjects must meet the following criteria at the qualifying coronary catheterization procedure:

• Evidence of coronary heart disease (at least one lesion in a native coronary artery that has > 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
• Left main coronary artery < 50% reduction in lumen diameter by visual estimation
• Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a > 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI).

Exclusion Criteria:

• Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS
• New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%
• Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
• Known hemorrhagic stroke
• Uncontrolled hypertension at randomization
• Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
• Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c [HbA1c] > 9%) at screening.
• Moderate to severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m²) at screening.

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; Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.	Drug: Placebo; Administered by subcutaneous injection
Experimental: Evolocumab; Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.	Biological: Evolocumab; Administered by subcutaneous injection; Other Names: AMG 145; Repatha®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Percent Atheroma Volume at Week 78	Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.	Baseline and week 78

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Atheroma Volume at Week 78	Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.	Baseline and week 78
Percentage of Participants With Regression in Percent Atheroma Volume	Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma. Regression in PAV was defined as any reduction from baseline in PAV.	Baseline and week 78
Percentage of Participants With Regression in Total Atheroma Volume	Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants. Regression in TAV was defined as any reduction from baseline in TAV.	Baseline and week 78

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
• Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951.
• Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJP, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Honda S, Shishikura D, Scherer DJ, Borgman M, Brennan DM, Wolski K, Nissen SE. Effect of Evolocumab on Coronary Plaque Composition. J Am Coll Cardiol. 2018 Oct 23;72(17):2012-2021. doi: 10.1016/j.jacc.2018.06.078.
• Puri R, Nissen SE, Somaratne R, Cho L, Kastelein JJ, Ballantyne CM, Koenig W, Anderson TJ, Yang J, Kassahun H, Wasserman SM, Scott R, Borgman M, Nicholls SJ. Impact of PCSK9 inhibition on coronary atheroma progression: Rationale and design of Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound (GLAGOV). Am Heart J. 2016 Jun;176:83-92. doi: 10.1016/j.ahj.2016.01.019. Epub 2016 Feb 17.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2013
• Primary Completion (Actual): July 12, 2016
• Study Completion (Actual): July 29, 2016

Study Registration Dates

• First Submitted: March 15, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Cholesterol; Elevated Cholesterol; High Cholesterol; Raised Cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Evolocumab
• Other Study ID Numbers: 20120153; 2012-004208-37 (EudraCT Number)