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HypercholesterolemiaPhase 2NCT05261126

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

A Phase 2 study testing Enclitide Chloride in people with Hypercholesterolemia and Familial Hypercholesterolemia, run by Merck Sharp & Dohme LLC at 63 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Enclitide Chloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
381 participants
Where
63 sitesin 8 countries
Study dates
10 Mar 2022to 28 Nov 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

63 sites in 8 countries.

63 sites in 8 countries

United States20 sites

  • New Mexico Clinical Research & Osteoporosis Center ( Site 0032)

    Albuquerque, New Mexico, 87106

  • Westside Medical Associates of Los Angeles ( Site 0026)

    Beverly Hills, California, 90211

  • Excel Medical Clinical Trials ( Site 0042)

    Boca Raton, Florida, 33434

  • Alliance for Multispecialty Research, LLC ( Site 0050)

    Coral Gables, Florida, 33134

  • Dallas Diabetes Research Center ( Site 0012)

    Dallas, Texas, 75230

  • altoona center for clinical research ( Site 0045)

    Duncansville, Pennsylvania, 16635

  • Healthcare Research Network - Chicago ( Site 0037)

    Flossmoor, Illinois, 60422

  • Piedmont Research Partners ( Site 0005)

    Fort Mill, South Carolina, 29707

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

    Houston, Texas, 77030

  • Midwest Institute For Clinical Research ( Site 0036)

    Indianapolis, Indiana, 46260

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

    Jackson, Mississippi, 39216

  • Jubilee Clinical Research ( Site 0047)

    Las Vegas, Nevada, 89106

  • L-MARC Research Center ( Site 0003)

    Louisville, Kentucky, 40213

  • Mid Hudson Medical Research ( Site 0004)

    New Windsor, New York, 12553

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

    Richmond, Virginia, 23294

  • Clinical Trials Research ( Site 0007)

    Sacramento, California, 95821

  • Northeast Clinical Research of San Antonio ( Site 0014)

    San Antonio, Texas, 78233

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

    Santa Ana, California, 92704

  • ForCare Clinical Research ( Site 0017)

    Tampa, Florida, 33613

  • Cotton O'Neil Mulvane ( Site 0022)

    Topeka, Kansas, 66606

Other trials in United States

Mexico10 sites

  • Centro de Atención e Investigación Clínica ( Site 0214)

    Aguascalientes, 20129

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

    Ciudad Madero, Tamaulipas, 89440

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

    Guadalajara, Jalisco, 04460

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

    Guadalajara, Jalisco, 44150

  • Medical Care and Research SA de CV ( Site 0211)

    Mérida, Yucatán, 97070

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

    Mexico City, Mexico City, 11410

  • Hospital Angeles Mocel ( Site 0209)

    Mexico City, Mexico City, 11850

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

    Mexico City, Mexico City, 14080

  • Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0200)

    Monterrey, Nuevo León, 64460

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

    Xalapa, Veracruz, 91193

Other trials in Mexico

Japan8 sites

  • Seiwa Clinic ( Site 1605)

    Adachi-ku, Tokyo, 123-0845

  • meiwa hospital ( Site 1602)

    Chiyoda-ku, Tokyo, 101-0041

  • Kyoto Okamoto Memorial Hospital ( Site 1611)

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

  • Chubu Rosal Hospital ( Site 1612)

    Nagoya, Aichi-ken, 455-8530

  • Kitada Clinic ( Site 1604)

    Osaka, Osaka, 538-0044

  • Heishinkai Medical Group ToCROM Clinic ( Site 1601)

    Shinjuku-ku, Tokyo, 160-0008

  • Medical Corporation Heishinkai OCROM Clinic ( Site 1600)

    Suita-shi, Osaka, 565-0853

  • Sekino Hospital ( Site 1603)

    Toshimaku, Tokyo, 171-0014

Other trials in Japan

Norway8 sites

  • Nordlandssykehuset ( Site 0709)

    Bodø, Nordland, 8005

  • Akershus Universitetssykehus-Hjertemedisinsk Avdeling ( Site 0705)

    Lørenskog, Akershus, 1478

  • Oslo Universitetssykehus Aker-Preventiv kardiologi Aker ( Site 0704)

    Oslo, 0316

  • Oslo Universitetssykehus Rikshospitalet-Kardiologisk avdeling ( Site 0702)

    Oslo, 0372

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

    Oslo, 0450

  • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 0700)

    Oslo, 0586

  • Stavanger Universitetssykehus ( Site 0706)

    Stavanger, Rogaland, 4011

  • Sykehuset i Vestfold-Hjerteseksjonen ( Site 0703)

    Tønsberg, Vestfold, 3103

Other trials in Norway

Germany5 sites

  • Charité Campus Virchow-Klinikum ( Site 0505)

    Berlin, 13353

  • Ambulantes Herzzentrum Kassel ( Site 0501)

    Kassel, Hesse, 34121

  • Universitätsklinikum Leipzig ( Site 0500)

    Leipzig, Saxony, 04103

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

    München, Bavaria, 80336

  • Kardiologische Gemeinschaftspraxis ( Site 0502)

    Nuremberg, Bavaria, 90402

Other trials in Germany

United Kingdom5 sites

  • Layton Medical Centre ( Site 1303)

    Blackpool, Lancashire, FY3 7EN

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

    Glasgow, Glasgow City, G51 4TF

  • Royal Free Hospital ( Site 1311)

    London, England, NW32QG

  • William Harvey Heart Centre ( Site 1308)

    London, London, City of, EC1M 5PZ

  • Walsall Manor Hospital ( Site 1309)

    West Midlands, Walsall, WS2 9PS

Other trials in United Kingdom

South Korea4 sites

  • Keimyung University Dongsan Hospital ( Site 1703)

    Daegu, Taegu-Kwangyokshi, 42601

  • Seoul National University Hospital ( Site 1702)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System ( Site 1701)

    Seoul, 03722

  • Samsung Medical Center ( Site 1700)

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)3 sites

  • Hacettepe Universitesi ( Site 1002)

    Ankara, 06230

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

    Bornova, İzmir, 35100

  • Eskisehir Osmangazi University-Cardiology ( Site 1000)

    Eskişehir, 26480

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Being tested
Enclitide Chloride, Placebo
Medical subject headings
Hypercholesterolemia, Hyperlipoproteinemia Type II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enclitide ChlorideDrug

    Also called MK-0616

    Enclitide Chloride administered orally

  • PlaceboDrug

    Placebo matching enclitide chloride administered orally

Study groups in NCT05261126
Study groupRoleWhat they receive
Enclitide Chloride 6 mgExperimentalParticipants will receive 6 mg of enlicitide chloride orally QD for 8 weeks
Receives: Drug: Enclitide Chloride
Enclitide Chloride 12 mgExperimentalParticipants will receive 12 mg of enlicitide chloride orally QD for 8 weeks
Receives: Drug: Enclitide Chloride
Enclitide Chloride 18 mgExperimentalParticipants will receive 18 mg of enlicitide chloride orally QD for 8 weeks
Receives: Drug: Enclitide Chloride
Enclitide Chloride 30 mgExperimentalParticipants will receive 30 mg of enlicitide chloride orally QD for 8 weeks
Receives: Drug: Enclitide Chloride
PlaceboPlacebo comparatorParticipants will receive enlicitide chloride-matching placebo orally QD for 8 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and up to Week 8

  2. 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.

    Measured: Up to approximately 17 Weeks

  3. 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.

    Measured: Up to approximately 9 Weeks

Secondary outcomes (3)

  1. Percent Change From Baseline in Apolipoprotein B (ApoB) at 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.

    Measured: Baseline and up to Week 8

  2. Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at 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.

    Measured: Baseline and up to Week 8

  3. Percentage of Participants With LDL-C Value at Goal at 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.

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start10 Mar 2022
  3. Primary completion28 Nov 2022
  4. Study completion28 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05261126
Sponsor's protocol ID
0616-008
Other IDs
MK-0616-008, jRCT2031210701, 2021-005221-24
Status last verified
Nov 2024
First submitted
22 Feb 2022
Last updated
9 Dec 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 36889610

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enclitide Chloride in people with Hypercholesterolemia and Familial Hypercholesterolemia, run by Merck Sharp & Dohme LLC at 63 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Mexico, Japan, Norway, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8 (time frame: Baseline and up to Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05261126, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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