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A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05952869
Recruitment Status : Active, not recruiting
First Posted : July 19, 2023
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE July 10, 2023
First Posted Date  ICMJE July 19, 2023
Last Update Posted Date March 13, 2024
Actual Study Start Date  ICMJE August 8, 2023
Estimated Primary Completion Date April 28, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2023)
  • Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24 [ Time Frame: Baseline and 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) [ Time Frame: Up to ~60 weeks ]
    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 [ Time Frame: Up to ~52 weeks ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2023)
  • Mean percent change from baseline in LDL-C at Week 52 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Familial Hypercholesterolemia
Intervention  ICMJE
  • Drug: MK-0616
    Oral tablet
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: MK-0616
    Participants will receive 20 mg of MK-0616 orally once daily (QD) for up to 52 weeks.
    Intervention: Drug: MK-0616
  • Placebo Comparator: Placebo
    Participants will receive MK-0616-matching placebo orally QD for up to 52 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2023)
270
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 28, 2025
Estimated Primary Completion Date April 28, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Chile,   Colombia,   Czechia,   Finland,   Hong Kong,   Hungary,   Israel,   Netherlands,   New Zealand,   Norway,   Singapore,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05952869
Other Study ID Numbers  ICMJE 0616-017
MK-0616-017 ( Other Identifier: Merck )
2022-502782-14 ( Registry Identifier: EU CT )
U1111-1285-4257 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP