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A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

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ClinicalTrials.gov Identifier: NCT05952856
Recruitment Status : Recruiting
First Posted : July 19, 2023
Last Update Posted : April 8, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Familial Hypercholesterolemia Drug: MK-0616 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
Actual Study Start Date : August 10, 2023
Estimated Primary Completion Date : September 15, 2025
Estimated Study Completion Date : September 24, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MK-0616
Participants will receive 20 mg of MK-0616 orally once daily (QD) for up to 52 weeks.
 Drug: MK-0616
Oral tablet
Placebo Comparator: Placebo
Participants will receive MK-0616-matching placebo orally QD for up to 52 weeks.
 Drug: Placebo
Oral tablet


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.
  • Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
  • If on any lipid-lowering therapies (LLTs), should be on a stable dose 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 without adequate washout
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05952856


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05952856    
Other Study ID Numbers: 0616-013
MK-0616-013 ( Other Identifier: Merck )
2022-502777-42 ( Registry Identifier: EU CT )
U1111-1285-4164 ( Other Identifier: UTN )
jRCT2031230320 ( Registry Identifier: Japan Registry of Clinical Trials (jRCT) )
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: April 8, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias