Back to resultsA Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
Primary Purpose
Hypercholesterolemia, Familial Hypercholesterolemia
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MK-0616
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria: Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history Is treated with a moderate- or high-intensity statin medication Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change Exclusion Criteria: Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH Has a history of heart failure or heart failure hospitalization within 3 months before first study visit Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
Sites / Locations
- Alliance for Multispecialty Research, LLC ( Site 0023)Recruiting
- Excel Medical Clinical Trials ( Site 0008)Recruiting
- Advanced Pharma Research ( Site 0007)Recruiting
- Progressive Medical Research ( Site 0021)Recruiting
- Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)Recruiting
- Synexus Clinical Research US - Evansville ( Site 0031)Recruiting
- Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)Recruiting
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)Recruiting
- Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)Recruiting
- Jubilee Clinical Research ( Site 0030)Recruiting
- Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041)Recruiting
- Velocity Clinical Research, Salt Lake City ( Site 0004)Recruiting
- Health Research of Hampton Roads, Inc. ( Site 0020)Recruiting
- Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)Recruiting
- Ecogene-21 ( Site 0510)Recruiting
- Diex Recherche Trois-Rivieres ( Site 0513)Recruiting
- Clinical Research Chile SpA ( Site 0804)Recruiting
- CDIEM ( Site 0814)Recruiting
- Enroll SpA ( Site 0803)Recruiting
- Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)Recruiting
- Queen Mary Hospital-Medical ( Site 3300)Recruiting
- Prince of Wales Hospital ( Site 3304)Recruiting
- Radboudumc-internal medicine ( Site 1952)Recruiting
- Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)Recruiting
- Pacific Clinical Research Network - Rotorua ( Site 2902)Recruiting
- New Zealand Clinical Research (Christchurch) ( Site 2901)Recruiting
- Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2000)Recruiting
- HOSPITAL CLINICO DE VALENCIA ( Site 2321)Recruiting
- Mackay Memorial Hospital -Tamshui Branch ( Site 3109)Recruiting
- Shin Kong Wu Ho-Su Memorial Hospital ( Site 3106)Recruiting
- National Taiwan University Hospital ( Site 3100)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MK-0616
Placebo
Arm Description
Participants will receive 20 mg of MK-0616 orally once daily (QD) for up to 52 weeks.
Participants will receive MK-0616-matching placebo orally QD for up to 52 weeks.
Outcomes
Primary Outcome Measures
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
Number of participants with 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.
Number of participants who discontinue study drug due to an AE
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.
Secondary Outcome Measures
Mean percent change from baseline in LDL-C at Week 52
Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C.
Mean percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.
Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.
Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a).
Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24
Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline.
Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24
Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline.
Full Information
NCT ID
NCT05952869
First Posted
July 10, 2023
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05952869
Brief Title
A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
September 16, 2025 (Anticipated)
Study Completion Date
September 16, 2025 (Anticipated)
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
Yes
5. Study Description
Brief Summary
The goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that MK-0616 is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MK-0616
Arm Type
Experimental
Arm Description
Participants will receive 20 mg of MK-0616 orally once daily (QD) for up to 52 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive MK-0616-matching placebo orally QD for up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
MK-0616
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
Time Frame
Baseline and Week 24
Title
Number of participants with 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.
Time Frame
Up to ~60 weeks
Title
Number of participants who discontinue study drug due to an AE
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.
Time Frame
Up to ~52 weeks
Secondary Outcome Measure Information:
Title
Mean percent change from baseline in LDL-C at Week 52
Description
Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C.
Time Frame
Baseline and Week 52
Title
Mean percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.
Time Frame
Baseline and Week 24
Title
Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.
Time Frame
Baseline and Week 24
Title
Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a).
Time Frame
Baseline and Week 24
Title
Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline.
Time Frame
Baseline and Week 24
Title
Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline.
Time Frame
Baseline and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
Is treated with a moderate- or high-intensity statin medication
Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change
Exclusion Criteria:
Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
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
Alliance for Multispecialty Research, LLC ( Site 0023)
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
615-591-0211
Facility Name
Excel Medical Clinical Trials ( Site 0008)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
561-756-8206
Facility Name
Advanced Pharma Research ( Site 0007)
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
786-732-4281
Facility Name
Progressive Medical Research ( Site 0021)
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
386-304-7070
Facility Name
Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-557-1722
Facility Name
Synexus Clinical Research US - Evansville ( Site 0031)
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
812-477-2760
Facility Name
Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
317-893-1900
Facility Name
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
248-312-0025
Facility Name
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
402-413-6363
Facility Name
Jubilee Clinical Research ( Site 0030)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
702-631-5000
Facility Name
Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
336-713-8335
Facility Name
Velocity Clinical Research, Salt Lake City ( Site 0004)
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
801-542-8190
Facility Name
Health Research of Hampton Roads, Inc. ( Site 0020)
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
757-591-8100
Facility Name
Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+61 2 95158832
Facility Name
Ecogene-21 ( Site 0510)
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
418-545-1252
Facility Name
Diex Recherche Trois-Rivieres ( Site 0513)
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 4P3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
819-801-9797
Facility Name
Clinical Research Chile SpA ( Site 0804)
City
Valdivia
State/Province
Los Rios
ZIP/Postal Code
5110683
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56940601237
Facility Name
CDIEM ( Site 0814)
City
Providencia
State/Province
Region M. De Santiago
ZIP/Postal Code
7500859
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56 9 4405 2528
Facility Name
Enroll SpA ( Site 0803)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500587
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56964790949
Facility Name
Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+358405404999
Facility Name
Queen Mary Hospital-Medical ( Site 3300)
City
Pok Fu Lam
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
85222553711
Facility Name
Prince of Wales Hospital ( Site 3304)
City
Shatin
ZIP/Postal Code
NT
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+85235053593
Facility Name
Radboudumc-internal medicine ( Site 1952)
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0031243618819
Facility Name
Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0031 20 566 2649
Facility Name
Pacific Clinical Research Network - Rotorua ( Site 2902)
City
Rotorua
State/Province
Bay Of Plenty
ZIP/Postal Code
3010
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
073477870
Facility Name
New Zealand Clinical Research (Christchurch) ( Site 2901)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+64274366380
Facility Name
Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2000)
City
Oslo
ZIP/Postal Code
0316
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
47 23034869
Facility Name
HOSPITAL CLINICO DE VALENCIA ( Site 2321)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34687011684
Facility Name
Mackay Memorial Hospital -Tamshui Branch ( Site 3109)
City
New Taipei City
State/Province
New Taipei
ZIP/Postal Code
251
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886975835141
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital ( Site 3106)
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
111
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0955604673
Facility Name
National Taiwan University Hospital ( Site 3100)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
88622312345665350
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
Links:
URL
http://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=0616-017&&kw=0616-017
Description
Plain Language Summary
Learn more about this trial
A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
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