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

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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

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 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.

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 : 270 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 Heterozygous Familial Hypercholesterolemia
Actual Study Start Date : August 8, 2023
Estimated Primary Completion Date : April 28, 2025
Estimated Study Completion Date : April 28, 2025

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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
Placebo


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 (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 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
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): NCT05952869


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: NCT05952869    
Other Study ID Numbers: 0616-017
MK-0616-017 ( Other Identifier: Merck )
2022-502782-14 ( Registry Identifier: EU CT )
U1111-1285-4257 ( Other Identifier: UTN )
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 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