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

November 14, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, 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 enclitide chloride tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum ( Site 0505)
    • Bayern
      • München, Bayern, Germany, 80336
        • Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0504)
      • Nuremberg, Bayern, Germany, 90402
        • Kardiologische Gemeinschaftspraxis ( Site 0502)
    • Hessen
      • Kassel, Hessen, Germany, 34121
        • Ambulantes Herzzentrum Kassel ( Site 0501)
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universitätsklinikum Leipzig ( Site 0500)
  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 455-8530
        • Chubu Rosal Hospital ( Site 1612)
    • Kyoto
      • Kuse-gun Kumiyama-cho, Kyoto, Japan, 613-0034
        • Kyoto Okamoto Memorial Hospital ( Site 1611)
    • Osaka
      • Osaka-city, Osaka, Japan, 538-0044
        • Kitada Clinic ( Site 1604)
      • Suita-shi, Osaka, Japan, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic ( Site 1600)
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 123-0845
        • Seiwa Clinic ( Site 1605)
      • Chiyoda-ku, Tokyo, Japan, 101-0041
        • meiwa hospital ( Site 1602)
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Heishinkai Medical Group ToCROM Clinic ( Site 1601)
      • Toshimaku, Tokyo, Japan, 171-0014
        • Sekino Hospital ( Site 1603)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 1702)
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System ( Site 1701)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center ( Site 1700)
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, Korea, Republic of, 42601
        • Keimyung University Dongsan Hospital ( Site 1703)
  • Mexico
      • Aguascalientes, Mexico, 20129
        • Centro de Atención e Investigación Clínica ( Site 0214)
    • Distrito Federal
      • Ciudad de México, Distrito Federal, Mexico, 11410
        • Bio Investigación AMARC, S.C. ( Site 0204)
      • Mexico City, Distrito Federal, Mexico, 11850
        • Hospital Angeles Mocel ( Site 0209)
      • Mexico City, Distrito Federal, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0212)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 04460
        • Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 0205)
      • Guadalajara, Jalisco, Mexico, 44150
        • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occident-Unidad de Investigación Clínica Cardio
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0200)
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares-Subinvestigation ( Site 0201)
    • Veracruz
      • Xalapa, Veracruz, Mexico, 91193
        • Hospital Angeles Xalapa-Internal Medicine-Cardiology ( Site 0202)
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Medical Care and Research SA de CV ( Site 0211)
  • Norway
      • Oslo, Norway, 0316
        • Oslo Universitetssykehus Aker-Preventiv kardiologi Aker ( Site 0704)
      • Oslo, Norway, 0372
        • Oslo Universitetssykehus Rikshospitalet-Kardiologisk avdeling ( Site 0702)
      • Oslo, Norway, 0450
        • Oslo Universitetssykehus Ullevål-Hjertemedisinsk avdeling, Ullevål ( Site 0701)
      • Oslo, Norway, 0586
        • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 0700)
    • Akershus
      • Lørenskog, Akershus, Norway, 1478
        • Akershus Universitetssykehus-Hjertemedisinsk Avdeling ( Site 0705)
    • Nordland
      • Bodø, Nordland, Norway, 8005
        • Nordlandssykehuset ( Site 0709)
    • Rogaland
      • Stavanger, Rogaland, Norway, 4011
        • Stavanger Universitetssykehus ( Site 0706)
    • Vestfold
      • Tønsberg, Vestfold, Norway, 3103
        • Sykehuset i Vestfold-Hjerteseksjonen ( Site 0703)
  • Turkey
      • Ankara, Turkey, 06230
        • Hacettepe Universitesi ( Site 1002)
      • Eskisehir, Turkey, 26480
        • Eskisehir Osmangazi University-Cardiology ( Site 1000)
    • Izmir
      • Bornova, Izmir, Turkey, 35100
        • Ege University Medicine of Faculty-Cardilogy Department ( Site 1003)
  • United Kingdom
    • England
      • London, England, United Kingdom, NW32QG
        • Royal Free Hospital ( Site 1311)
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1310)
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 7EN
        • Layton Medical Centre ( Site 1303)
    • London, City Of
      • London, London, City Of, United Kingdom, EC1M 5PZ
        • William Harvey Heart Centre ( Site 1308)
    • Walsall
      • West Midlands, Walsall, United Kingdom, WS2 9PS
        • Walsall Manor Hospital ( Site 1309)
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Westside Medical Associates of Los Angeles ( Site 0026)
      • Sacramento, California, United States, 95821
        • Clinical Trials Research ( Site 0007)
      • Santa Ana, California, United States, 92704
        • National Research Institute (NRI) - Santa Ana ( Site 0024)
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials ( Site 0042)
      • Coral Gables, Florida, United States, 33134
        • Alliance for Multispecialty Research, LLC ( Site 0050)
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research ( Site 0017)
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Healthcare Research Network - Chicago ( Site 0037)
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Midwest Institute For Clinical Research ( Site 0036)
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Mulvane ( Site 0022)
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center ( Site 0003)
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • The University of Mississippi Medical Center-Clinical Research and Trials Unit ( Site 0028)
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Jubilee Clinical Research ( Site 0047)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • New Mexico Clinical Research & Osteoporosis Center ( Site 0032)
    • New York
      • New Windsor, New York, United States, 12553
        • Mid Hudson Medical Research ( Site 0004)
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • altoona center for clinical research ( Site 0045)
    • South Carolina
      • Fort Mill, South Carolina, United States, 29707
        • Piedmont Research Partners ( Site 0005)
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center ( Site 0012)
      • Houston, Texas, United States, 77030
        • Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0051)
      • San Antonio, Texas, United States, 78233
        • Northeast Clinical Research of San Antonio ( Site 0014)
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research, Inc-research office ( Site 0019)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enclitide Chloride 6 mg
Participants will receive 6 mg of enlicitide chloride orally QD for 8 weeks
Drug: Enclitide Chloride
Enclitide Chloride administered orally
Other Names:
  • MK-0616
Experimental: Enclitide Chloride 12 mg
Participants will receive 12 mg of enlicitide chloride orally QD for 8 weeks
Drug: Enclitide Chloride
Enclitide Chloride administered orally
Other Names:
  • MK-0616
Experimental: Enclitide Chloride 18 mg
Participants will receive 18 mg of enlicitide chloride orally QD for 8 weeks
Drug: Enclitide Chloride
Enclitide Chloride administered orally
Other Names:
  • MK-0616
Experimental: Enclitide Chloride 30 mg
Participants will receive 30 mg of enlicitide chloride orally QD for 8 weeks
Drug: Enclitide Chloride
Enclitide Chloride administered orally
Other Names:
  • MK-0616
Placebo Comparator: Placebo
Participants will receive enlicitide chloride-matching placebo orally QD for 8 weeks
Drug: Placebo
Placebo matching enclitide chloride administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and up to Week 8
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.
Up to approximately 17 Weeks
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.
Up to approximately 9 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and up to Week 8
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.
Baseline and up to Week 8
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.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

November 28, 2022

Study Completion (Actual)

November 28, 2022

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0616-008
  • MK-0616-008 (Other Identifier: MSD)
  • jRCT2031210701 (Registry Identifier: jRCT)
  • 2021-005221-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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