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

NCT05261126 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: 0616-008MK-0616-008jRCT20312107012021-005221-24
• Study Type: interventional
• Target: 381
• Locations: 8 countries
• Sites: 63

Brief Summary

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.

Conditions

Hypercholesterolemia; Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (3)

• Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at 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)

  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

  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 Outcomes (3)

• Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8

  Baseline and up to Week 8

• Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8

  Baseline and up to Week 8

• Percentage of Participants With LDL-C Value at Goal at Week 8

  Week 8

Study Arms (5)

Enclitide Chloride 6 mg

EXPERIMENTAL

Participants will receive 6 mg of enlicitide chloride orally QD for 8 weeks

Drug: Enclitide Chloride

Enclitide Chloride 12 mg

EXPERIMENTAL

Participants will receive 12 mg of enlicitide chloride orally QD for 8 weeks

Drug: Enclitide Chloride

Enclitide Chloride 18 mg

EXPERIMENTAL

Participants will receive 18 mg of enlicitide chloride orally QD for 8 weeks

Drug: Enclitide Chloride

Enclitide Chloride 30 mg

EXPERIMENTAL

Participants will receive 30 mg of enlicitide chloride orally QD for 8 weeks

Drug: Enclitide Chloride

Placebo

PLACEBO COMPARATOR

Participants will receive enlicitide chloride-matching placebo orally QD for 8 weeks

Drug: Placebo

Interventions

Enclitide Chloride DRUG

Enclitide Chloride administered orally

Also known as: MK-0616

Enclitide Chloride 12 mg; Enclitide Chloride 18 mg; Enclitide Chloride 30 mg; Enclitide Chloride 6 mg

Placebo DRUG

Placebo matching enclitide chloride administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (63)

Westside Medical Associates of Los Angeles ( Site 0026)

Beverly Hills, California, 90211, United States

Location

Clinical Trials Research ( Site 0007)

Sacramento, California, 95821, United States

Location

National Research Institute (NRI) - Santa Ana ( Site 0024)

Santa Ana, California, 92704, United States

Location

Excel Medical Clinical Trials ( Site 0042)

Boca Raton, Florida, 33434, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0050)

Coral Gables, Florida, 33134, United States

Location

ForCare Clinical Research ( Site 0017)

Tampa, Florida, 33613, United States

Location

Healthcare Research Network - Chicago ( Site 0037)

Flossmoor, Illinois, 60422, United States

Location

Midwest Institute For Clinical Research ( Site 0036)

Indianapolis, Indiana, 46260, United States

Location

Cotton O'Neil Mulvane ( Site 0022)

Topeka, Kansas, 66606, United States

Location

L-MARC Research Center ( Site 0003)

Louisville, Kentucky, 40213, United States

Location

The University of Mississippi Medical Center-Clinical Research and Trials Unit ( Site 0028)

Jackson, Mississippi, 39216, United States

Location

Jubilee Clinical Research ( Site 0047)

Las Vegas, Nevada, 89106, United States

Location

New Mexico Clinical Research & Osteoporosis Center ( Site 0032)

Albuquerque, New Mexico, 87106, United States

Location

Mid Hudson Medical Research ( Site 0004)

New Windsor, New York, 12553, United States

Location

altoona center for clinical research ( Site 0045)

Duncansville, Pennsylvania, 16635, United States

Location

Piedmont Research Partners ( Site 0005)

Fort Mill, South Carolina, 29707, United States

Location

Dallas Diabetes Research Center ( Site 0012)

Dallas, Texas, 75230, United States

Location

Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0051)

Houston, Texas, 77030, United States

Location

Northeast Clinical Research of San Antonio ( Site 0014)

San Antonio, Texas, 78233, United States

Location

National Clinical Research, Inc-research office ( Site 0019)

Richmond, Virginia, 23294, United States

Location

Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0504)

München, Bavaria, 80336, Germany

Location

Kardiologische Gemeinschaftspraxis ( Site 0502)

Nuremberg, Bavaria, 90402, Germany

Location

Ambulantes Herzzentrum Kassel ( Site 0501)

Kassel, Hesse, 34121, Germany

Location

Universitätsklinikum Leipzig ( Site 0500)

Leipzig, Saxony, 04103, Germany

Location

Charité Campus Virchow-Klinikum ( Site 0505)

Berlin, 13353, Germany

Location

Chubu Rosal Hospital ( Site 1612)

Nagoya, Aichi-ken, 455-8530, Japan

Location

Kyoto Okamoto Memorial Hospital ( Site 1611)

Kuse-gun Kumiyama-cho, Kyoto, 613-0034, Japan

Location

Kitada Clinic ( Site 1604)

Osaka, Osaka, 538-0044, Japan

Location

Medical Corporation Heishinkai OCROM Clinic ( Site 1600)

Suita-shi, Osaka, 565-0853, Japan

Location

Seiwa Clinic ( Site 1605)

Adachi-ku, Tokyo, 123-0845, Japan

Location

meiwa hospital ( Site 1602)

Chiyoda-ku, Tokyo, 101-0041, Japan

Location

Heishinkai Medical Group ToCROM Clinic ( Site 1601)

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

Sekino Hospital ( Site 1603)

Toshimaku, Tokyo, 171-0014, Japan

Location

Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 0205)

Guadalajara, Jalisco, 04460, Mexico

Location

Unidad de Investigaci�n Cl�nica Cardiometabolica de Occident-Unidad de Investigación Clínica Cardio

Guadalajara, Jalisco, 44150, Mexico

Location

Bio Investigación AMARC, S.C. ( Site 0204)

Mexico City, Mexico City, 11410, Mexico

Location

Hospital Angeles Mocel ( Site 0209)

Mexico City, Mexico City, 11850, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0212)

Mexico City, Mexico City, 14080, Mexico

Location

Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0200)

Monterrey, Nuevo León, 64460, Mexico

Location

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares-Subinvestigation ( Site 0201)

Ciudad Madero, Tamaulipas, 89440, Mexico

Location

Hospital Angeles Xalapa-Internal Medicine-Cardiology ( Site 0202)

Xalapa, Veracruz, 91193, Mexico

Location

Medical Care and Research SA de CV ( Site 0211)

Mérida, Yucatán, 97070, Mexico

Location

Centro de Atención e Investigación Clínica ( Site 0214)

Aguascalientes, 20129, Mexico

Location

Akershus Universitetssykehus-Hjertemedisinsk Avdeling ( Site 0705)

Lørenskog, Akershus, 1478, Norway

Location

Nordlandssykehuset ( Site 0709)

Bodø, Nordland, 8005, Norway

Location

Stavanger Universitetssykehus ( Site 0706)

Stavanger, Rogaland, 4011, Norway

Location

Sykehuset i Vestfold-Hjerteseksjonen ( Site 0703)

Tønsberg, Vestfold, 3103, Norway

Location

Oslo Universitetssykehus Aker-Preventiv kardiologi Aker ( Site 0704)

Oslo, 0316, Norway

Location

Oslo Universitetssykehus Rikshospitalet-Kardiologisk avdeling ( Site 0702)

Oslo, 0372, Norway

Location

Oslo Universitetssykehus Ullevål-Hjertemedisinsk avdeling, Ullevål ( Site 0701)

Oslo, 0450, Norway

Location

Oslo Universitetssykehus Aker-Lipidklinikken ( Site 0700)

Oslo, 0586, Norway

Location

Keimyung University Dongsan Hospital ( Site 1703)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

Location

Seoul National University Hospital ( Site 1702)

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System ( Site 1701)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 1700)

Seoul, 06351, South Korea

Location

Ege University Medicine of Faculty-Cardilogy Department ( Site 1003)

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Hacettepe Universitesi ( Site 1002)

Ankara, 06230, Turkey (Türkiye)

Location

Eskisehir Osmangazi University-Cardiology ( Site 1000)

Eskişehir, 26480, Turkey (Türkiye)

Location

Royal Free Hospital ( Site 1311)

London, England, NW32QG, United Kingdom

Location

Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1310)

Glasgow, Glasgow City, G51 4TF, United Kingdom

Location

Layton Medical Centre ( Site 1303)

Blackpool, Lancashire, FY3 7EN, United Kingdom

Location

William Harvey Heart Centre ( Site 1308)

London, London, City of, EC1M 5PZ, United Kingdom

Location

Walsall Manor Hospital ( Site 1309)

West Midlands, Walsall, WS2 9PS, United Kingdom

Location

Related Publications (1)

• Ballantyne CM, Banka P, Mendez G, Garcia R, Rosenstock J, Rodgers A, Mendizabal G, Mitchel Y, Catapano AL. Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616. J Am Coll Cardiol. 2023 Apr 25;81(16):1553-1564. doi: 10.1016/j.jacc.2023.02.018. Epub 2023 Mar 6.

  PMID: 36889610 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipoproteinemia Type II

Interventions

MK-0616

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 2, 2022
• Study Start: March 10, 2022
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: December 9, 2024
• Results First Posted: December 6, 2023

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

NO (8); TU (3); ME (10); KR (4); DE (5); GB (5); US (20); JP (8)