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Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Evinacumab
Matching placebo
Background Lipid Modifying Therapy (LMT)
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The inclusion/ exclusion criteria below, include, but are not limited to, the following:

Key Inclusion Criteria:

  1. Men and women, ages 18 through 80 at the screening visit
  2. Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD
  3. A history of clinical ASCVD, for those patients who are non-HeFH.
  4. Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening
  5. For those patients with HeFH who are not receiving a statin at screening, documentation of inability to tolerate at least 2 statins.
  6. Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for at least 8 weeks prior to the screening visit
  7. For those patients with a history of clinical ASCVD, serum LDL-C ≥ 70 mg/dL at screening (1 repeat lab is allowed)
  8. For those patients without a history of clinical ASCVD, serum LDL-C ≥ 100 mg/dL at screening (1 repeat lab is allowed)
  9. Provide signed informed consent

Key Exclusion Criteria:

  1. Known history of homozygous FH (clinically, or by previous genotyping)
  2. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
  3. Newly diagnosed diabetes (within 3 months prior to screening)
  4. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before screening)

  5. Laboratory findings during screening period (not including randomization labs):

    1. Triglycerides > 400 mg/dL (> 4.52 mmol/L) for patients without a known history of diabetes mellitus; OR Triglycerides > 300 mg/dL (> 3.39 mmol/L) for patients with a known history of diabetes mellitus
    2. Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody (associated with a positive HCV ribonucleic acid [RNA] polymerase chain reaction)
    3. Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women of childbearing potential
    4. Estimated glomerular filtration rate < 30 mL/min/1.73 m^2
    5. TSH > 1.5 x ULN
    6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN
  6. Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening visit or time of randomization
  7. History of heart failure (New York Heart Association [NYHA] Class III-IV) within 12 months before screening
  8. History of MI, unstable angina leading to hospitalization, CABG surgery, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior screening
  9. History of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer)
  10. Having received LDL apheresis within 2 months before screening
  11. Pregnant or breast-feeding women
  12. Women of childbearing potential who are unwilling to practice a highly effective birth control method
  13. Men who are sexually active with women of childbearing potential (WOCBP) and are unwilling to consistently use condoms during the study drug treatment period regardless of vasectomy status.

Sites / Locations

  • Cedars-Sinai Medical Center
  • Office of Dr. John D Homan MD
  • Preventive Cardiology Inc
  • Care Research Center Inc
  • Florida Lipid Institute
  • St. Vincent Medical Group, Inc
  • University of Kansas Medical Center
  • EMMC Northeast Cardiology Assocites
  • University of Maryland School of Medicine
  • Massachusetts General Hospital
  • Heart Health Cardiology
  • Minneapolis Heart Institute Foundation
  • University of Minnesota
  • Washington University School of Medicine
  • Mt Sinai Ichan Medical Institute
  • Duke University Medical Center
  • Rowan Diagnostic Clinic
  • Capital Area Research, LLC
  • The University Of Texas Health Science Center Houston
  • San Antonio Premiere Internal Medicine
  • Clear Clinical Research, LLC
  • PharmaTex Research
  • Wasatch Clinical Research
  • Royal Prince Alfred Hospital
  • Redcliffe Hospital
  • University Hospital Innsbruck - Tyrolean Hospital
  • Medizinische Universitaetsklinik Graz
  • Robarts Research Institute
  • SKDS Research Inc.
  • Centre Etudes Cliniques Econogene-21
  • Clinique des maladies lipidiques de Quebec
  • CCR Prague, S.R.O
  • Univerzita Karlova v Praze 1 Lekarska Fakulta
  • University Hospital, Charles University
  • Ikem Institut Klinicke A Experimentalni Mediciny
  • Sydvestjysk Sygehus
  • Regionshospitalet Herning
  • Hopital G Et R Laennec
  • Houpital Du Bocage
  • Edith Wolfson Medical Center
  • Galilee Medical Center
  • Sheba Mc
  • Sourasky Medical Center, Cardiovascular Research Center
  • Azienda Ospedaliero Universitaria Federico II di Napoli
  • Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica
  • Ausl Della Romagna-Ospedale Degli Infermi
  • Dipartimento di Medicina Traslazionale e di Precisione dell'Università degli Studi di
  • Tokyo-Eki Center-building Clinic
  • Shonan Fujisawa Tokushukai Hospital
  • Minamino Cardiovascular Hospital
  • Saitama Medical University Hospital
  • Istishari Hospital
  • King Abdullah University Hospital-1
  • King Abdullah University Hospital-2
  • King Abdullah University Hospital
  • VOC Hoorn
  • Admiraal de Ruyter Ziekenhuis
  • Academic Medical Center
  • Universitair Medisch Centrum Utrech - Locatie AZU
  • Lipid and Diabetes Research Group
  • Papamoa Pines Medical Centre
  • Clinical Horizons NZ Ltd
  • M3 Helse AS
  • Halina Serafin NZOZ Centrum Medyczne SERAFIN-MED
  • Nzoz Przychodnia Specjalistyczna
  • Wojewodzki Szpital Specjalistyczny
  • Slaskie Centrum Chorob Serca, III Katedra i Oddzial Kliniczny Kardiologii SUM- Oddzial Chorob Serca i Naczyn
  • Federal State Budgetary Institution Research Institute for Complex Issues of Cardiovacsular Disease
  • National Research Center For Preventative Medicine of Federal Agency of High Technology Medical Aid
  • Federal State Budget Institution Out-patient Clinic 3
  • NII of Therapy and Preventive Medicine
  • Municipal Medical and Prophylactic Institution - City Hospital for Emergency Care No.2
  • Limmited Liability Company International Medical Centre SOGAZ
  • Federal State Institution of Healthcare Clinical Hospital #122 N.A.L.G Sokolov
  • LLC- Institute of Medical Research
  • Federal State Budgetary Institution Clinical-Diagnostic Center with Polyclinic
  • Samara Regional Clinical Cardiologic Dispensary
  • Cardiology Research Institute
  • The Charlotte Maxeke Johannesburg Academic Hospital
  • Jongaie Research
  • Dr JM Engelbrecht Trial Site
  • University of Cape Town
  • TREAD Research CC
  • Hospital Universitario A Coruna
  • Hospital Universitario Miguel Servet
  • Hospital Universitario de Bellvitge
  • Hospital Universitario Reina Sofia
  • Hospital Universitario Virgen de las Nieves (HUVN)
  • Hospital Universitario Virgen del Rocio
  • Karolinska University Hospital
  • Akardo MedSite
  • Karolinska Institutet
  • Akademiska sjukhuset
  • Royal Free Hospital-Royal Free London NHS Foundation Trust
  • Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A: dosing regimen 1

Group A: dosing regimen 2

Group A: dosing regimen 3

Group A: matching placebo

Group B: dosing regimen 1

Group B: dosing regimen 2

Group B: matching placebo

Arm Description

SC Evinacumab QW for 16 weeks

SC Evinacumab Q2W for 16 weeks (alternating with matching placebo on opposite weeks)

SC Evinacumab QW for 16 weeks

Placebo SC QW for 16 weeks

Intravenous (IV) Evinacumab Q4W for 24 weeks

IV Evinacumab Q4W for 24 weeks

Placebo IV Q4W for 24 weeks

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)

Secondary Outcome Measures

Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)
Percent Change From Baseline in Apo B at Week 24 (ITT Estimand)
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand)
Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand)
Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)
Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)
Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand)
Percentage of Participants with Calculated LDL-C < 50 milligrams/deciliter (mg/dL) [1.30 Millimoles per liter (mmol/L)] at Week 16 (ITT Estimand)
Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand)
Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand)
Percent Change From Baseline in Total Cholesterol at Week 24 (ITT Estimand)
Percent Change From Baseline in Fasting Triglycerides at Week 16 (ITT Estimand)
Percent Change From Baseline in Fasting Triglycerides at Week 24 (ITT Estimand)
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 16 (ITT Estimand)
Percent Change From Baseline in Lipoprotein (a) [Lp(a)] at Week 24 (ITT Estimand)

Full Information

First Posted
June 1, 2017
Last Updated
January 27, 2023
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03175367
Brief Title
Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
May 22, 2020 (Actual)
Study Completion Date
December 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: dosing regimen 1
Arm Type
Experimental
Arm Description
SC Evinacumab QW for 16 weeks
Arm Title
Group A: dosing regimen 2
Arm Type
Experimental
Arm Description
SC Evinacumab Q2W for 16 weeks (alternating with matching placebo on opposite weeks)
Arm Title
Group A: dosing regimen 3
Arm Type
Experimental
Arm Description
SC Evinacumab QW for 16 weeks
Arm Title
Group A: matching placebo
Arm Type
Experimental
Arm Description
Placebo SC QW for 16 weeks
Arm Title
Group B: dosing regimen 1
Arm Type
Experimental
Arm Description
Intravenous (IV) Evinacumab Q4W for 24 weeks
Arm Title
Group B: dosing regimen 2
Arm Type
Experimental
Arm Description
IV Evinacumab Q4W for 24 weeks
Arm Title
Group B: matching placebo
Arm Type
Experimental
Arm Description
Placebo IV Q4W for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Evinacumab
Other Intervention Name(s)
REGN1500
Intervention Description
SC or IV administration
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Intervention Description
SC or IV administration
Intervention Type
Other
Intervention Name(s)
Background Lipid Modifying Therapy (LMT)
Intervention Description
All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Apo B at Week 24 (ITT Estimand)
Time Frame
Baseline and Week 24
Title
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand)
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand)
Time Frame
Baseline and Week 24
Title
Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)
Time Frame
Week 16
Title
Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)
Time Frame
Week 16
Title
Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand)
Description
Percentage of Participants with Calculated LDL-C < 50 milligrams/deciliter (mg/dL) [1.30 Millimoles per liter (mmol/L)] at Week 16 (ITT Estimand)
Time Frame
Week 16
Title
Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand)
Time Frame
Baseline and Week 24
Title
Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand)
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Total Cholesterol at Week 24 (ITT Estimand)
Time Frame
Baseline and Week 24
Title
Percent Change From Baseline in Fasting Triglycerides at Week 16 (ITT Estimand)
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Fasting Triglycerides at Week 24 (ITT Estimand)
Time Frame
Baseline and Week 24
Title
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 16 (ITT Estimand)
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Lipoprotein (a) [Lp(a)] at Week 24 (ITT Estimand)
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The inclusion/ exclusion criteria below, include, but are not limited to, the following: Key Inclusion Criteria: Men and women, ages 18 through 80 at the screening visit Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD A history of clinical ASCVD, for those patients who are non-HeFH. Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening For those patients with HeFH who are not receiving a statin at screening, documentation of inability to tolerate at least 2 statins. Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for at least 8 weeks prior to the screening visit For those patients with a history of clinical ASCVD, serum LDL-C ≥ 70 mg/dL at screening (1 repeat lab is allowed) For those patients without a history of clinical ASCVD, serum LDL-C ≥ 100 mg/dL at screening (1 repeat lab is allowed) Provide signed informed consent Key Exclusion Criteria: Known history of homozygous FH (clinically, or by previous genotyping) Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins Newly diagnosed diabetes (within 3 months prior to screening) Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before screening) Laboratory findings during screening period (not including randomization labs): Triglycerides > 400 mg/dL (> 4.52 mmol/L) for patients without a known history of diabetes mellitus; OR Triglycerides > 300 mg/dL (> 3.39 mmol/L) for patients with a known history of diabetes mellitus Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody (associated with a positive HCV ribonucleic acid [RNA] polymerase chain reaction) Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women of childbearing potential Estimated glomerular filtration rate < 30 mL/min/1.73 m^2 TSH > 1.5 x ULN Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening visit or time of randomization History of heart failure (New York Heart Association [NYHA] Class III-IV) within 12 months before screening History of MI, unstable angina leading to hospitalization, CABG surgery, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior screening History of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer) Having received LDL apheresis within 2 months before screening Pregnant or breast-feeding women Women of childbearing potential who are unwilling to practice a highly effective birth control method Men who are sexually active with women of childbearing potential (WOCBP) and are unwilling to consistently use condoms during the study drug treatment period regardless of vasectomy status.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Office of Dr. John D Homan MD
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3668
Country
United States
Facility Name
Preventive Cardiology Inc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Care Research Center Inc
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Florida Lipid Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
St. Vincent Medical Group, Inc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
EMMC Northeast Cardiology Assocites
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Heart Health Cardiology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mt Sinai Ichan Medical Institute
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Rowan Diagnostic Clinic
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Capital Area Research, LLC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
The University Of Texas Health Science Center Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Antonio Premiere Internal Medicine
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78220
Country
United States
Facility Name
Clear Clinical Research, LLC
City
Schertz
State/Province
Texas
ZIP/Postal Code
78154
Country
United States
Facility Name
PharmaTex Research
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Redcliffe Hospital
City
Redcliffe
State/Province
Queensland
ZIP/Postal Code
1020
Country
Australia
Facility Name
University Hospital Innsbruck - Tyrolean Hospital
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medizinische Universitaetsklinik Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Robarts Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5B7
Country
Canada
Facility Name
SKDS Research Inc.
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Centre Etudes Cliniques Econogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Clinique des maladies lipidiques de Quebec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
CCR Prague, S.R.O
City
Praha
State/Province
Prague 3
ZIP/Postal Code
13000
Country
Czechia
Facility Name
Univerzita Karlova v Praze 1 Lekarska Fakulta
City
Karlov
State/Province
Praha 2
ZIP/Postal Code
121 08
Country
Czechia
Facility Name
University Hospital, Charles University
City
Hradec Kralove
ZIP/Postal Code
50008
Country
Czechia
Facility Name
Ikem Institut Klinicke A Experimentalni Mediciny
City
Prague
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Sydvestjysk Sygehus
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Regionshospitalet Herning
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Hopital G Et R Laennec
City
Nantes
State/Province
Cedex
ZIP/Postal Code
44000
Country
France
Facility Name
Houpital Du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Edith Wolfson Medical Center
City
H̱olon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
Country
Israel
Facility Name
Sheba Mc
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Sourasky Medical Center, Cardiovascular Research Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria Federico II di Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ausl Della Romagna-Ospedale Degli Infermi
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Dipartimento di Medicina Traslazionale e di Precisione dell'Università degli Studi di
City
Rome
ZIP/Postal Code
00185
Country
Italy
Facility Name
Tokyo-Eki Center-building Clinic
City
Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Shonan Fujisawa Tokushukai Hospital
City
Fujisawa-shi
ZIP/Postal Code
251-0041
Country
Japan
Facility Name
Minamino Cardiovascular Hospital
City
Hachioji
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Saitama Medical University Hospital
City
Iruma-gun
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Istishari Hospital
City
Amman
ZIP/Postal Code
11184
Country
Jordan
Facility Name
King Abdullah University Hospital-1
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
Facility Name
King Abdullah University Hospital-2
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
Facility Name
King Abdullah University Hospital
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
Facility Name
VOC Hoorn
City
Hoorn
State/Province
Hoorn Noord-Hollan
ZIP/Postal Code
1624 NP
Country
Netherlands
Facility Name
Admiraal de Ruyter Ziekenhuis
City
Goes
State/Province
Zeeland
ZIP/Postal Code
4462 RA
Country
Netherlands
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrech - Locatie AZU
City
Utrecht
Country
Netherlands
Facility Name
Lipid and Diabetes Research Group
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Papamoa Pines Medical Centre
City
Papamoa
ZIP/Postal Code
3118
Country
New Zealand
Facility Name
Clinical Horizons NZ Ltd
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
M3 Helse AS
City
Oslo
ZIP/Postal Code
0373
Country
Norway
Facility Name
Halina Serafin NZOZ Centrum Medyczne SERAFIN-MED
City
Żarów
State/Province
Dolnoslaskie
ZIP/Postal Code
58-130
Country
Poland
Facility Name
Nzoz Przychodnia Specjalistyczna
City
Ruda Slaska
State/Province
Podlaskie
ZIP/Postal Code
41709
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Bytom
Country
Poland
Facility Name
Slaskie Centrum Chorob Serca, III Katedra i Oddzial Kliniczny Kardiologii SUM- Oddzial Chorob Serca i Naczyn
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Federal State Budgetary Institution Research Institute for Complex Issues of Cardiovacsular Disease
City
Kemerovo
ZIP/Postal Code
65000
Country
Russian Federation
Facility Name
National Research Center For Preventative Medicine of Federal Agency of High Technology Medical Aid
City
Moscow
ZIP/Postal Code
119990
Country
Russian Federation
Facility Name
Federal State Budget Institution Out-patient Clinic 3
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
NII of Therapy and Preventive Medicine
City
Novosibirsk
ZIP/Postal Code
630089
Country
Russian Federation
Facility Name
Municipal Medical and Prophylactic Institution - City Hospital for Emergency Care No.2
City
Rostov-on-Don
ZIP/Postal Code
34406
Country
Russian Federation
Facility Name
Limmited Liability Company International Medical Centre SOGAZ
City
Saint Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
Federal State Institution of Healthcare Clinical Hospital #122 N.A.L.G Sokolov
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
LLC- Institute of Medical Research
City
Saint Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Federal State Budgetary Institution Clinical-Diagnostic Center with Polyclinic
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Samara Regional Clinical Cardiologic Dispensary
City
Samara
ZIP/Postal Code
443070
Country
Russian Federation
Facility Name
Cardiology Research Institute
City
Tomsk
ZIP/Postal Code
34012
Country
Russian Federation
Facility Name
The Charlotte Maxeke Johannesburg Academic Hospital
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2000
Country
South Africa
Facility Name
Jongaie Research
City
Pretoria
State/Province
West Gauteng
ZIP/Postal Code
182
Country
South Africa
Facility Name
Dr JM Engelbrecht Trial Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
713
Country
South Africa
Facility Name
University of Cape Town
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
TREAD Research CC
City
Parow
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Hospital Universitario A Coruna
City
A Coruña
State/Province
A Coruna
ZIP/Postal Code
15001
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
State/Province
Aragon
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves (HUVN)
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Karolinska University Hospital
City
Malmö
Country
Sweden
Facility Name
Akardo MedSite
City
Stockholm
ZIP/Postal Code
11446
Country
Sweden
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
SE-182 88
Country
Sweden
Facility Name
Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Royal Free Hospital-Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33196153
Citation
Rosenson RS, Burgess LJ, Ebenbichler CF, Baum SJ, Stroes ESG, Ali S, Khilla N, Hamlin R, Pordy R, Dong Y, Son V, Gaudet D. Evinacumab in Patients with Refractory Hypercholesterolemia. N Engl J Med. 2020 Dec 10;383(24):2307-2319. doi: 10.1056/NEJMoa2031049. Epub 2020 Nov 15.
Results Reference
derived

Learn more about this trial

Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

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