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A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

Primary Purpose

Hypercholesterolemia, Familial Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MK-0616
Placebo
Sponsored by
Merck Sharp & Dohme LLC
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

Inclusion Criteria:

  • History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a corresponding LDL-C that falls within the protocol-specified range at screening.
  • Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days before screening, or has not received treatment with any lipid-lowering therapy for ≥30 days before screening.
  • A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 8 weeks after the last dose of study intervention.

Exclusion Criteria:

  • History of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria.
  • History of nephrotic syndrome.
  • History of unstable angina, a myocardial infarction, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening.
  • Has poorly controlled diabetes mellitus, defined as hemoglobin A1C (A1C) ≥9.0% at Screening.
  • History of malignancy ≤3 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe limitations relative to screening.
  • Currently participating in or has previously participated in an interventional clinical study within 3 months before Screening.
  • Has moderate or greater renal insufficiency.

Sites / Locations

  • Westside Medical Associates of Los Angeles ( Site 0026)
  • Clinical Trials Research ( Site 0007)
  • National Research Institute (NRI) - Santa Ana ( Site 0024)
  • Excel Medical Clinical Trials ( Site 0042)
  • Alliance for Multispecialty Research, LLC ( Site 0050)
  • ForCare Clinical Research ( Site 0017)
  • Healthcare Research Network - Chicago ( Site 0037)
  • Midwest Institute For Clinical Research ( Site 0036)
  • Cotton O'Neil Mulvane ( Site 0022)
  • L-MARC Research Center ( Site 0003)
  • The University of Mississippi Medical Center-Clinical Research and Trials Unit ( Site 0028)
  • Jubilee Clinical Research ( Site 0047)
  • New Mexico Clinical Research & Osteoporosis Center ( Site 0032)
  • Mid Hudson Medical Research ( Site 0004)
  • altoona center for clinical research ( Site 0045)
  • Piedmont Research Partners ( Site 0005)
  • Dallas Diabetes Research Center ( Site 0012)
  • Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0051)
  • Northeast Clinical Research of San Antonio ( Site 0014)
  • National Clinical Research, Inc-research office ( Site 0019)
  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0504)
  • Kardiologische Gemeinschaftspraxis ( Site 0502)
  • Ambulantes Herzzentrum Kassel ( Site 0501)
  • Universitätsklinikum Leipzig ( Site 0500)
  • Charité Campus Virchow-Klinikum ( Site 0505)
  • Chubu Rosal Hospital ( Site 1612)
  • Kyoto Okamoto Memorial Hospital ( Site 1611)
  • Kitada Clinic ( Site 1604)
  • Medical Corporation Heishinkai OCROM Clinic ( Site 1600)
  • Seiwa Clinic ( Site 1605)
  • meiwa hospital ( Site 1602)
  • Heishinkai Medical Group ToCROM Clinic ( Site 1601)
  • Sekino Hospital ( Site 1603)
  • Keimyung University Dongsan Hospital ( Site 1703)
  • Seoul National University Hospital ( Site 1702)
  • Severance Hospital, Yonsei University Health System ( Site 1701)
  • Samsung Medical Center ( Site 1700)
  • Bio Investigación AMARC, S.C. ( Site 0204)
  • Hospital Angeles Mocel ( Site 0209)
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0212)
  • Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 0205)
  • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occident-Unidad de Investigación Clínica Cardio
  • Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0200)
  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares-Subinvestigation ( Site 0201)
  • Hospital Angeles Xalapa-Internal Medicine-Cardiology ( Site 0202)
  • Medical Care and Research SA de CV ( Site 0211)
  • Centro de Atención e Investigación Clínica ( Site 0214)
  • Akershus Universitetssykehus-Hjertemedisinsk Avdeling ( Site 0705)
  • Nordlandssykehuset ( Site 0709)
  • Stavanger Universitetssykehus ( Site 0706)
  • Sykehuset i Vestfold-Hjerteseksjonen ( Site 0703)
  • Oslo Universitetssykehus Aker-Preventiv kardiologi Aker ( Site 0704)
  • Oslo Universitetssykehus Rikshospitalet-Kardiologisk avdeling ( Site 0702)
  • Oslo Universitetssykehus Ullevål-Hjertemedisinsk avdeling, Ullevål ( Site 0701)
  • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 0700)
  • Ege University Medicine of Faculty-Cardilogy Department ( Site 1003)
  • Hacettepe Universitesi ( Site 1002)
  • Eskisehir Osmangazi University-Cardiology ( Site 1000)
  • Royal Free Hospital ( Site 1311)
  • Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1310)
  • Layton Medical Centre ( Site 1303)
  • William Harvey Heart Centre ( Site 1308)
  • Walsall Manor Hospital ( Site 1309)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

MK-0616 Dose 1

MK-0616 Dose 2

MK-0616 Dose 3

MK-0616 Dose 4

Placebo

Arm Description

MK-0616 Dose 1 administered orally once daily (QD) for 8 weeks

MK-0616 Dose 2 administered orally QD for 8 weeks

MK-0616 Dose 3 administered orally QD for 8 weeks

MK-0616 Dose 4 administered orally QD for 8 weeks

Placebo administered orally QD for 8 weeks

Outcomes

Primary Outcome Measures

Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8
Blood samples will be collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C.
Percentage of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Percentage of Participants Who Discontinue Study Intervention Due to AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Secondary Outcome Measures

Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8
Blood samples will be collected at baseline and after 8 weeks of treatment to assess mean percent change in ApoB.
Percent Change from Baseline in Non-High-density Lipoprotein Cholesterol (non-HDL-C) at Week 8
Blood samples will be collected at baseline and after 8 weeks of treatment to assess mean percent change in non-HDL-C.
Percentage of Participants with LDL-C Value at Goal at Week 8
LDL-C goal is defined as: LDL-C <70 mg/dL (<1.81 mmol/L) in participants with clinical atherosclerotic cardiovascular disease (ASCVD) LDL-C <100 mg/dL (<2.59 mmol/L) in participants with an ASCVD risk-equivalent and/or a 10-year risk of having an ASCVD event that is ≥7.5% LDL-C <130 mg/dL (<3.37mmol/L) in participants with a 10-year risk of having an ASCVD event that is ≥5.0% and <7.5%

Full Information

First Posted
February 22, 2022
Last Updated
May 10, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05261126
Brief Title
A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
Official Title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
November 28, 2022 (Actual)
Study Completion Date
November 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of MK-0616, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of MK-0616 tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MK-0616 Dose 1
Arm Type
Experimental
Arm Description
MK-0616 Dose 1 administered orally once daily (QD) for 8 weeks
Arm Title
MK-0616 Dose 2
Arm Type
Experimental
Arm Description
MK-0616 Dose 2 administered orally QD for 8 weeks
Arm Title
MK-0616 Dose 3
Arm Type
Experimental
Arm Description
MK-0616 Dose 3 administered orally QD for 8 weeks
Arm Title
MK-0616 Dose 4
Arm Type
Experimental
Arm Description
MK-0616 Dose 4 administered orally QD for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally QD for 8 weeks
Intervention Type
Drug
Intervention Name(s)
MK-0616
Intervention Description
MK-0616 administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching MK-0616 administered orally
Primary Outcome Measure Information:
Title
Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8
Description
Blood samples will be collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C.
Time Frame
Baseline and Week 8
Title
Percentage of Participants Who Experience One or More Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 16 Weeks
Title
Percentage of Participants Who Discontinue Study Intervention Due to AEs
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 8 Weeks
Secondary Outcome Measure Information:
Title
Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8
Description
Blood samples will be collected at baseline and after 8 weeks of treatment to assess mean percent change in ApoB.
Time Frame
Baseline and Week 8
Title
Percent Change from Baseline in Non-High-density Lipoprotein Cholesterol (non-HDL-C) at Week 8
Description
Blood samples will be collected at baseline and after 8 weeks of treatment to assess mean percent change in non-HDL-C.
Time Frame
Baseline and Week 8
Title
Percentage of Participants with LDL-C Value at Goal at Week 8
Description
LDL-C goal is defined as: LDL-C <70 mg/dL (<1.81 mmol/L) in participants with clinical atherosclerotic cardiovascular disease (ASCVD) LDL-C <100 mg/dL (<2.59 mmol/L) in participants with an ASCVD risk-equivalent and/or a 10-year risk of having an ASCVD event that is ≥7.5% LDL-C <130 mg/dL (<3.37mmol/L) in participants with a 10-year risk of having an ASCVD event that is ≥5.0% and <7.5%
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a corresponding LDL-C that falls within the protocol-specified range at screening. Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days before screening, or has not received treatment with any lipid-lowering therapy for ≥30 days before screening. A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 8 weeks after the last dose of study intervention. Exclusion Criteria: History of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria. History of nephrotic syndrome. History of unstable angina, a myocardial infarction, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening. Has poorly controlled diabetes mellitus, defined as hemoglobin A1C (A1C) ≥9.0% at Screening. History of malignancy ≤3 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe limitations relative to screening. Currently participating in or has previously participated in an interventional clinical study within 3 months before Screening. Has moderate or greater renal insufficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Westside Medical Associates of Los Angeles ( Site 0026)
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Clinical Trials Research ( Site 0007)
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
National Research Institute (NRI) - Santa Ana ( Site 0024)
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Excel Medical Clinical Trials ( Site 0042)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0050)
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
ForCare Clinical Research ( Site 0017)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Healthcare Research Network - Chicago ( Site 0037)
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Midwest Institute For Clinical Research ( Site 0036)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Cotton O'Neil Mulvane ( Site 0022)
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
L-MARC Research Center ( Site 0003)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
The University of Mississippi Medical Center-Clinical Research and Trials Unit ( Site 0028)
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Jubilee Clinical Research ( Site 0047)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center ( Site 0032)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Mid Hudson Medical Research ( Site 0004)
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
altoona center for clinical research ( Site 0045)
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Piedmont Research Partners ( Site 0005)
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
Dallas Diabetes Research Center ( Site 0012)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0051)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northeast Clinical Research of San Antonio ( Site 0014)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
National Clinical Research, Inc-research office ( Site 0019)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0504)
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
Kardiologische Gemeinschaftspraxis ( Site 0502)
City
Nuremberg
State/Province
Bayern
ZIP/Postal Code
90402
Country
Germany
Facility Name
Ambulantes Herzzentrum Kassel ( Site 0501)
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34121
Country
Germany
Facility Name
Universitätsklinikum Leipzig ( Site 0500)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum ( Site 0505)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Chubu Rosal Hospital ( Site 1612)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Kyoto Okamoto Memorial Hospital ( Site 1611)
City
Kuse-gun Kumiyama-cho
State/Province
Kyoto
ZIP/Postal Code
613-0034
Country
Japan
Facility Name
Kitada Clinic ( Site 1604)
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
538-0044
Country
Japan
Facility Name
Medical Corporation Heishinkai OCROM Clinic ( Site 1600)
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
Seiwa Clinic ( Site 1605)
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
123-0845
Country
Japan
Facility Name
meiwa hospital ( Site 1602)
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-0041
Country
Japan
Facility Name
Heishinkai Medical Group ToCROM Clinic ( Site 1601)
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
Sekino Hospital ( Site 1603)
City
Toshimaku
State/Province
Tokyo
ZIP/Postal Code
171-0014
Country
Japan
Facility Name
Keimyung University Dongsan Hospital ( Site 1703)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 1702)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System ( Site 1701)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 1700)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Bio Investigación AMARC, S.C. ( Site 0204)
City
Ciudad de México
State/Province
Distrito Federal
ZIP/Postal Code
11410
Country
Mexico
Facility Name
Hospital Angeles Mocel ( Site 0209)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0212)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 0205)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
04460
Country
Mexico
Facility Name
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occident-Unidad de Investigación Clínica Cardio
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44150
Country
Mexico
Facility Name
Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0200)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares-Subinvestigation ( Site 0201)
City
Ciudad Madero
State/Province
Tamaulipas
ZIP/Postal Code
89440
Country
Mexico
Facility Name
Hospital Angeles Xalapa-Internal Medicine-Cardiology ( Site 0202)
City
Xalapa
State/Province
Veracruz
ZIP/Postal Code
91193
Country
Mexico
Facility Name
Medical Care and Research SA de CV ( Site 0211)
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Centro de Atención e Investigación Clínica ( Site 0214)
City
Aguascalientes
ZIP/Postal Code
20129
Country
Mexico
Facility Name
Akershus Universitetssykehus-Hjertemedisinsk Avdeling ( Site 0705)
City
Lørenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
Facility Name
Nordlandssykehuset ( Site 0709)
City
Bodø
State/Province
Nordland
ZIP/Postal Code
8005
Country
Norway
Facility Name
Stavanger Universitetssykehus ( Site 0706)
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4011
Country
Norway
Facility Name
Sykehuset i Vestfold-Hjerteseksjonen ( Site 0703)
City
Tønsberg
State/Province
Vestfold
ZIP/Postal Code
3103
Country
Norway
Facility Name
Oslo Universitetssykehus Aker-Preventiv kardiologi Aker ( Site 0704)
City
Oslo
ZIP/Postal Code
0316
Country
Norway
Facility Name
Oslo Universitetssykehus Rikshospitalet-Kardiologisk avdeling ( Site 0702)
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Oslo Universitetssykehus Ullevål-Hjertemedisinsk avdeling, Ullevål ( Site 0701)
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Oslo Universitetssykehus Aker-Lipidklinikken ( Site 0700)
City
Oslo
ZIP/Postal Code
0586
Country
Norway
Facility Name
Ege University Medicine of Faculty-Cardilogy Department ( Site 1003)
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Hacettepe Universitesi ( Site 1002)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Eskisehir Osmangazi University-Cardiology ( Site 1000)
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Royal Free Hospital ( Site 1311)
City
London
State/Province
England
ZIP/Postal Code
NW32QG
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1310)
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Layton Medical Centre ( Site 1303)
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
William Harvey Heart Centre ( Site 1308)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1M 5PZ
Country
United Kingdom
Facility Name
Walsall Manor Hospital ( Site 1309)
City
West Midlands
State/Province
Walsall
ZIP/Postal Code
WS2 9PS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
36889610
Citation
Ballantyne CM, Banka P, Mendez G, Garcia R, Rosenstock J, Rodgers A, Mendizabal G, Mitchel Y, Catapano AL. Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616. J Am Coll Cardiol. 2023 Apr 25;81(16):1553-1564. doi: 10.1016/j.jacc.2023.02.018. Epub 2023 Mar 6.
Results Reference
result

Learn more about this trial

A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

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