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

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: NCT05261126
Recruitment Status : Completed
First Posted : March 2, 2022
Results First Posted : December 6, 2023
Last Update Posted : December 6, 2023
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Familial Hypercholesterolemia Drug: MK-0616 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
Actual Study Start Date : March 10, 2022
Actual Primary Completion Date : November 28, 2022
Actual Study Completion Date : November 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MK-0616 6 mg
Participants will receive 6 mg of MK-0616 orally QD for 8 weeks
 Drug: MK-0616
MK-0616 administered orally
Experimental: MK-0616 12 mg
Participants will receive 12 mg of MK-0616 orally QD for 8 weeks
 Drug: MK-0616
MK-0616 administered orally
Experimental: MK-0616 18 mg
Participants will receive 18 mg of MK-0616 orally QD for 8 weeks
 Drug: MK-0616
MK-0616 administered orally
Experimental: MK-0616 30 mg
Participants will receive 30 mg of MK-0616 orally QD for 8 weeks
 Drug: MK-0616
MK-0616 administered orally
Placebo Comparator: Placebo
Participants will receive MK-0616-matching placebo orally QD for 8 weeks
 Drug: Placebo
Placebo matching MK-0616 administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8 [ Time Frame: Baseline and up to Week 8 ]
    Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C. Based on a constrained longitudinal analysis (cLDA) model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in LDL-C at week 8 was reported.

  2. Percentage of Participants Who Experienced One or More Adverse Events (AEs) [ Time Frame: Up to approximately 17 Weeks ]
    An AE was 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 could 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. The percentage of participants who experienced at least one AE was reported.

  3. Percentage of Participants Who Discontinued Study Intervention Due to AEs [ Time Frame: Up to approximately 9 Weeks ]
    An AE was 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 could 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. The percentage of participants who discontinued study intervention due to AEs was reported.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8 [ Time Frame: Baseline and up to Week 8 ]
    Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in ApoB. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in ApoB at week 8 was reported.

  2. Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8 [ Time Frame: Baseline and up to Week 8 ]
    Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in non-HDL-C. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in non-HDL-C at week 8 was reported.

  3. Percentage of Participants With LDL-C Value at Goal at Week 8 [ Time Frame: Week 8 ]
    LDL-C goal was 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%, OR 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%. The percentage of participants with LDL-C value at goal at week 8 were reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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): NCT05261126


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
  Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme LLC:
Study Protocol and Statistical Analysis Plan  [PDF] May 24, 2022

More Information
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Additional Information:

Publications of Results:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05261126    
Other Study ID Numbers: 0616-008
MK-0616-008 ( Other Identifier: Merck )
jRCT2031210701 ( Registry Identifier: jRCT )
2021-005221-24 ( EudraCT Number )
First Posted: March 2, 2022    Key Record Dates
Results First Posted: December 6, 2023
Last Update Posted: December 6, 2023
Last Verified: November 2023
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