AzTrials
AzTrials

HypercholesterolemiaPhase 3NCT05952856

A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

A Phase 3 study testing Enlicitide Decanoate in people with Hypercholesterolemia and Familial Hypercholesterolemia, run by Merck Sharp & Dohme LLC at 168 sites in 14 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 goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Enlicitide Decanoate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,912 participants
Where
168 sitesin 14 countries
Study dates
10 Aug 2023to 28 Jul 2025
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.
  • Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
  • If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change.

Who cannot join

  • 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 without adequate washout

Trial locations and contacts

168 sites in 14 countries.

168 sites in 14 countries

United States49 sites

  • New Mexico Clinical Research & Osteoporosis Center ( Site 0005)

    Albuquerque, New Mexico, 87106

  • National Heart Institute-Research ( Site 0087)

    Beverly Hills, California, 90211

  • Excel Medical Clinical Trials ( Site 0053)

    Boca Raton, Florida, 33434

  • Alliance for Multispecialty Research, LLC ( Site 0088)

    Coral Gables, Florida, 33134

  • Velocity Clinical Research, Covington ( Site 0068)

    Covington, Louisiana, 70433

  • Velocity Clinical Research, Dallas ( Site 0114)

    Dallas, Texas, 75230

  • Alliance for Multispecialty Research, LLC ( Site 0093)

    Daphne, Alabama, 36526

  • altoona center for clinical research ( Site 0089)

    Duncansville, Pennsylvania, 16635

  • Velocity Clinical Research, Syracuse ( Site 0021)

    East Syracuse, New York, 13057

  • Synexus Clinical Research US, Inc. ( Site 0109)

    Evansville, Indiana, 47714

  • Lillestol Research ( Site 0026)

    Fargo, North Dakota, 58104

  • Healthcare Research Network - Chicago ( Site 0052)

    Flossmoor, Illinois, 60422

  • G&L Research ( Site 0043)

    Foley, Alabama, 36535

  • Piedmont Research Partners ( Site 0090)

    Fort Mill, South Carolina, 29707

  • Alliance for Multispecialty Research, LLC ( Site 0094)

    Fort Myers, Florida, 33912

  • Velocity Clinical Research, Greenville ( Site 0023)

    Greenville, South Carolina, 29615

  • Velocity Clinical Research, Gulfport ( Site 0039)

    Gulfport, Mississippi, 39503

  • Velocity Clinical Research, Hallandale Beach ( Site 0018)

    Hallandale, Florida, 33009

  • Healthcare Research Network - St. Louis ( Site 0054)

    Hazelwood, Missouri, 63042

  • Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)

    Houston, Texas, 77030

  • Midwest Institute For Clinical Research ( Site 0059)

    Indianapolis, Indiana, 46260

  • Jacksonville Center for Clinical Research ( Site 0049)

    Jacksonville, Florida, 32216

  • Holston Medical Group ( Site 0048)

    Kingsport, Tennessee, 37660

  • Alliance for Multispecialty Research, LLC ( Site 0008)

    Knoxville, Tennessee, 37920

  • Jubilee Clinical Research ( Site 0106)

    Las Vegas, Nevada, 89106

  • AB Clinical Trials ( Site 0070)

    Las Vegas, Nevada, 89119

  • Alliance for Multispecialty Research, LLC ( Site 0028)

    Lexington, Kentucky, 40509

  • L-MARC Research Center ( Site 0001)

    Louisville, Kentucky, 40213

  • East Coast Institute for Research, LLC ( Site 0033)

    Macon, Georgia, 31210

  • Manassas Clinical Research Center ( Site 0007)

    Manassas, Virginia, 20110

  • South Broward Research ( Site 0051)

    Miramar, Florida, 33027

  • Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)

    New York, New York, 10029

  • Health Research of Hampton Roads, Inc. ( Site 0044)

    Newport News, Virginia, 23606

  • Alliance for Multispecialty Research, LLC ( Site 0101)

    Norfolk, Virginia, 23502

  • Coastal Carolina Research Center ( Site 0006)

    North Charleston, South Carolina, 29405

  • Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)

    Phoenix, Arizona, 85020

  • Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009)

    Rapid City, South Dakota, 57701

  • Rainier Clinical Research Center ( Site 0116)

    Renton, Washington, 98057

  • National Clinical Research, Inc ( Site 0061)

    Richmond, Virginia, 23294

  • Velocity Clinical Research Rockville ( Site 0082)

    Rockville, Maryland, 20854

  • Clinical Trials Research ( Site 0115)

    Sacramento, California, 95821

  • Synexus Clinical Research US, Inc. ( Site 0110)

    Salt Lake City, Utah, 84106

  • Clinical Trials of Texas, LLC ( Site 0103)

    San Antonio, Texas, 78229

  • Velocity Clinical Research, Banning ( Site 0017)

    San Bernardino, California, 92408

  • Centricity Research Suffolk Family Medicine ( Site 0092)

    Suffolk, Virginia, 23435

  • Clinical Research Trials of Florida ( Site 0063)

    Tampa, Florida, 33607

  • Emerson Clinical Research Institute ( Site 0118)

    Washington D.C., District of Columbia, 20009

  • Velocity Clinical Research, Salt Lake City ( Site 0019)

    West Jordan, Utah, 84088

  • Cardiology Consultants of Philadelphia Yardley ( Site 0097)

    Yardley, Pennsylvania, 19067

Other trials in United States

Japan23 sites

  • Teramoto Medical and Dental Clinic ( Site 3507)

    Bunkyo-ku, Tokyo, 113-0033

  • Tokyo-Eki Center-building Clinic ( Site 3505)

    Chuo-ku, Tokyo, 103-0027

  • Fukuwa Clinic ( Site 3504)

    Chuo-ku, Tokyo, 104-0031

  • Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)

    Fukuoka, 810-0001

  • Hiroshima City Hiroshima Citizens Hospital ( Site 3518)

    Hiroshima, 730-8518

  • Saitama Medical University Hospital ( Site 3506)

    Iruma, Saitama, 350-0495

  • Rinku General Medical Center ( Site 3503)

    Izumisano, Osaka, 598-8577

  • National Hospital Organization Kanazawa Medical Center ( Site 3508)

    Kanazawa, Ishikawa-ken, 920-8650

  • Shiraiwa Medical Clinic ( Site 3514)

    Kashihara, Osaka, 582-0005

  • Kato Clinic of Internal Medicine ( Site 3509)

    Katsushika-ku, Tokyo, 125-0054

  • Hirohata Naika Clinic ( Site 3513)

    Kitakyusyu-shi, Fukuoka, 807-0857

  • Kanno Naika ( Site 3511)

    Mitaka, Tokyo, 181-0013

  • Hirano Medical Clinic ( Site 3522)

    Morioka, Iwate, 020-0132

  • Nakakinen clinic ( Site 3510)

    Naka, Ibaraki, 311-0113

  • Sugawara Clinic ( Site 3519)

    Nerima-ku, Tokyo, 177-0041

  • Shin Clinic ( Site 3517)

    Ōta-ku, Tokyo, 144-0051

  • Shirai Healthcare Clinic Izumichuou ( Site 3527)

    Sendai, Miyagi, 981-3133

  • Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)

    Shinjuku-ku, Tokyo, 160-0008

  • Mitsukoshi Health and Welfare Foundation ( Site 3521)

    Shinjuku-ku, Tokyo, 160-0023

  • Medical Corporation Heishinkai OCROM Clinic ( Site 3501)

    Suita-shi, Osaka, 565-0853

  • Teikyo University Hospital ( Site 3500)

    tabashi City, Tokyo, 173-8606

  • Mishuku Hospital ( Site 3524)

    Tokyo, 153-0051

  • Noritake Clinic ( Site 3512)

    Ushiku, Ibaraki, 300-1207

Other trials in Japan

China18 sites

  • Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 3300)

    Beijing, Beijing Municipality, 100029

  • Beijing Friendship Hospital Affiliate of Capital University-Cardiology ( Site 3303)

    Beijing, Beijing Municipality, 100050

  • Hunan Provincial People's Hospital-Cardiology ( Site 3317)

    Changsha, Hunan, 410005

  • Changzhou Second People's Hospital-Cardiology ( Site 3373)

    Changzhou, Jiangsu, 213000

  • Chengdu Second Municipal People's Hospital ( Site 3332)

    Chengdu, Sichuan, 610021

  • The Second Affiliated Hospital of Chongqing Medical University ( Site 3320)

    Chongqing, Chongqing Municipality, 400072

  • Chongqing University Three Gorges Hospital ( Site 3321)

    Chongqing, Chongqing Municipality, 404000

  • Guangdong Provincial People's Hospital-Cardiology ( Site 3304)

    Guangzhou, Guangdong, 510080

  • Zhujiang Hospital of Southern Medical University ( Site 3329)

    Guangzhou, Guangdong, 510280

  • Huizhou Municipal Central Hospital ( Site 3379)

    Huizhou, Guangdong, 516001

  • Jingzhou Central Hospital-Cardiology ( Site 3376)

    Jingzhou, Hubei, 434036

  • People's Hospital of Lishui City-department of cardiovascular ( Site 3302)

    Lishui, Zhejiang, 323000

  • The Third Hospital of Nanchang - Fuhe-cardiology ( Site 3378)

    Nanchang, Jiangxi, 330003

  • The University of Hong Kong-Shenzhen Hospital-Cardiovascular department ( Site 3318)

    Shenzhen, Guangdong, 518053

  • Siping Central People's Hospital-Cardiovascular Department ( Site 3311)

    Siping, Jilin, 136000

  • Wuhan Fourth Hospital ( Site 3356)

    Wuhan, Hubei, 430030

  • Xianyang Hospital of Yan'an University ( Site 3340)

    Xianyang, Shaanxi, 712000

  • Northern Jiangsu People's Hospital ( Site 3308)

    Yangzhou, Jiangsu, 225001

Other trials in China

South Korea15 sites

  • Dong-A University Hospital ( Site 3013)

    Busan, Pusan-Kwangyokshi, 49201

  • Pusan National University Hospital-Internal Medicine ( Site 3012)

    Busan, Pusan-Kwangyokshi, 49241

  • Chungbuk National University Hospital ( Site 3011)

    Cheongju-si, North Chungcheong, 28644

  • Keimyung University Dongsan Hospital CRC room 1 ( Site 3003)

    Daegu, Taegu-Kwangyokshi, 42601

  • Chonnam National University Hospital ( Site 3014)

    Gwangju, Kwangju-Kwangyokshi, 61469

  • Inje University Haeundae Paik Hospital ( Site 3010)

    Haeundae-gu, Pusan-Kwangyokshi, 48108

  • Seoul National University Bundang Hospital ( Site 3005)

    Seongnam, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 3001)

    Seoul, 03080

  • Kangbuk Samsung Hospital ( Site 3009)

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System ( Site 3002)

    Seoul, 03722

  • Asan Medical Center ( Site 3004)

    Seoul, 05505

  • Samsung Medical Center-cardiology ( Site 3000)

    Seoul, 06351

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)

    Seoul, 06591

  • Ajou University Hospital ( Site 3006)

    Suwon, Kyonggi-do, 16499

  • Wonju Severance Christian Hospital ( Site 3008)

    Wŏnju, Kang-won-do, 26426

Other trials in South Korea

Israel9 sites

  • Hillel Yaffe Medical Center ( Site 1705)

    Hadera, 3810101

  • Rambam Health Care Campus-internal department ( Site 1718)

    Haifa, 3109601

  • Shaare Zedek Medical Center ( Site 1710)

    Jerusalem, 9103102

  • Hadassah Medical Center ( Site 1706)

    Jerusalem, 9112001

  • Hadassah Medical Center ( Site 1709)

    Jerusalem, 9112001

  • Meir Medical Center. ( Site 1714)

    Kfar Saba, 4428164

  • Rabin Medical Center ( Site 1720)

    Petah Tikva, 4941 492

  • Sheba Medical Center ( Site 1708)

    Ramat Gan, 5265601

  • Yitzhak Shamir Medical Center. ( Site 1712)

    Tsrifin, 7033001

Other trials in Israel

Spain9 sites

  • Hospital Abente y Lago ( Site 2356)

    A Coruña, La Coruna, 15001

  • Hospital Universitario Fundacion ALcorcon-Endocrinologia y Nutrición ( Site 2316)

    Alcorcón, Madrid, Comunidad de, 28922

  • Vithas Hospital Sevilla-Unidad de Salud Metabólica. Diabetes y Obesidad ( Site 2349)

    Castilleja de la Cuesta, Sevilla, 41950

  • EBA CENTELLES ( Site 2311)

    Centelles, Catalonia, 08500

  • Hospital Universitario 12 de Octubre-Internal Medicine. Unidad de Ensayos Clínicos ( Site 2319)

    Madrid, 28041

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Endocrinologia y Nutrición ( Site 2344)

    Pozuelo de Alarcón, Madrid, 28223

  • CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 2320)

    Santiago de Compostela, La Coruna, 15706

  • Hospital Universitario Virgen Macarena ( Site 2352)

    Seville, Andalusia, 41009

  • HOSPITAL CLINICO DE VALENCIA-CARDIOLOGY ( Site 2321)

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

Taiwan7 sites

  • Changhua Christian Hospital ( Site 3101)

    Changhua, 50006

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 3102)

    Kaohsiung City, 83301

  • Chi Mei Medical Center-Cardiology ( Site 3104)

    Tainan, Tainan, 71004

  • National Cheng Kung University Hospital ( Site 3107)

    Tainan, 704

  • National Taiwan University Hospital ( Site 3100)

    Taipei, 10002

  • Taipei Medical University Hospital-Cardiology ( Site 3108)

    Taipei, 110

  • Taipei Veterans General Hospital ( Site 3106)

    Taipei, 112

Other trials in Taiwan

Argentina6 sites

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604)

    Buenos Aires, Buenos Aires F.D., C1425AGC

  • Fundación Respirar ( Site 0610)

    Buenos Aires, Buenos Aires F.D., C1426ABP

  • CEDIC ( Site 0612)

    CABA, Buenos Aires, C1060ABN

  • Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620)

    CABA, C1056ABI

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605)

    Mar del Plata, Buenos Aires, B7600FZO

  • Instituto de Investigaciones Clinicas Zarate ( Site 0600)

    Zárate, Buenos Aires, B2800DGH

Other trials in Argentina

Colombia6 sites

  • Ciensalud Ips S A S ( Site 0903)

    Barranquilla, Atlántico, 08001

  • Clinica de la Costa S.A.S. ( Site 0902)

    Barranquilla, Atlántico, 080020

  • Salud SURA Calle 100 ( Site 0918)

    Bogotá, Cundinamarca, 110231

  • Fundación Valle del Lili ( Site 0904)

    Cali, Valle del Cauca Department, 760032

  • Fundación Centro de Investigación Clínica CIC ( Site 0906)

    Medellín, Antioquia, 050021

  • Healthy Medical Center S.A.S ( Site 0913)

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Germany6 sites

  • Zentralklinik Bad Berka ( Site 1530)

    Bad Berka, Thuringia, 99437

  • Velocity Clinical Research GmbH Berlin ( Site 1502)

    Berlin, 10787

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1533)

    Berlin, 12203

  • Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1508)

    Dresden, Saxony, 01307

  • Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1542)

    Essen, North Rhine-Westphalia, 45359

  • Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels ( Site 1527)

    Hohenmölsen, Saxony-Anhalt, 06679

Other trials in Germany

Italy6 sites

  • Azienda Ospedaliera Garibaldi ( Site 1810)

    Catania, 95122

  • Centro Cardiologico Monzino ( Site 1804)

    Milan, Milano, 20138

  • ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 1811)

    Milan, Milano, 20162

  • Fondazione Policlinico Tor Vergata ( Site 1809)

    Rome, Lazio, 00133

  • Azienda Ospedaliera Sant'Andrea-Department of Clinical and Molecular Medicine ( Site 1807)

    Rome, Roma, 00189

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 1801)

    Turin, Piedmont, 10126

Other trials in Italy

South Africa6 sites

  • Tiervlei Trial Centre-Clinical ( Site 2246)

    Bellville, Cape Town, Western Cape, 7530

  • IATROS INTERNATIONAL ( Site 2247)

    Bloemfontein, Free State, 9301

  • TREAD Research ( Site 2253)

    Cape Town, Western Cape, 7500

  • University of Cape Town (UCT)-Medicine, Division of Lipidology ( Site 2259)

    Cape Town, Western Cape, 7925

  • Soweto Clinical Trials Centre ( Site 2242)

    Johannesburg, Gauteng, 1818

  • Charlotte Maxeke Johannesburg Academic Hospital-WCR-LIPIDS ( Site 2241)

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Turkey (Türkiye)6 sites

  • Hacettepe Universite Hastaneleri ( Site 2500)

    Altindağ, Ankara, 06230

  • Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)

    Ankara, 06800

  • Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)

    Bornova, İzmir, 35100

  • Eskisehir Osmangazi University-Cardiology ( Site 2510)

    Eskişehir, 26480

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri-endocrine ( Site 2522)

    Kayseri, 380280

  • Kocaeli Üniversitesi-Cardiology ( Site 2516)

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Mexico2 sites

  • Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)

    Guadalajara, Jalisco, 44600

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1071)

    Mexico City, Mexico City, 14080

Other trials in Mexico

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

Being tested
Enlicitide Decanoate, 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.

  • Enlicitide DecanoateDrug

    Also called MK-0616

    Oral tablet

  • PlaceboDrug

    Oral tablet

Study groups in NCT05952856
Study groupRoleWhat they receive
Enlicitide DecanoateExperimentalParticipants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
Receives: Drug: Enlicitide Decanoate
PlaceboPlacebo comparatorParticipants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24

    Blood samples collected at baseline and Week 24 were used to assess mean percent change in LDL-C.

    Measured: Baseline and Week 24

  2. Number of Participants With One or More Adverse Events (AEs)

    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.

    Measured: Up to 60 weeks

  3. Number of Participants Who Discontinued Study Drug Due to an AE

    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.

    Measured: Up to 52 weeks

Secondary outcomes (6)

  1. Mean Percent Change From Baseline in LDL-C at Week 52

    Blood samples collected at baseline and Week 52 were used to assess mean percent change in LDL-C.

    Measured: Baseline and Week 52

  2. Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24

    Blood samples collected at baseline and Week 24 were used to assess mean percent change in non-HDL-C.

    Measured: Baseline and Week 24

  3. Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24

    Blood samples collected at baseline and Week 24 were used to assess mean percent change in ApoB.

    Measured: Baseline and Week 24

  4. Percent Change From Baseline in Lipoprotein(a) (Lp(a)) at Week 24

    Blood samples collected at baseline and Week 24 were used to assess percent change in Lp(a).

    Measured: Baseline and Week 24

  5. Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24

    Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal.

    Measured: Baseline and Week 24

  6. Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24

    Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal.

    Measured: Baseline and Week 24

Timeline

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

  1. First posted19 Jul 2023
  2. Study start10 Aug 2023
  3. Primary completion28 Jul 2025
  4. Study completion28 Jul 2025

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,912 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05952856
Sponsor's protocol ID
0616-013
Other IDs
MK-0616-013, 2022-502777-42-01, U1111-1285-4164, jRCT2031230320
Status last verified
Aug 2026
First submitted
10 Jul 2023
Last updated
24 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Navar AM, Mikhailova E, Catapano AL, Banka P, Blom DJ, Cadena A, Kourpanidis S, Lepor NE, Tsukamoto K, Mendizabal G, Nunez J, Zhang W, Zhu P, Zhuo M, Ballantyne CM; CORALreef Lipids Investigators. A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide. N Engl J Med. 2026 Feb 5;394(6):529-539. doi: 10.1056/NEJMoa2511002.

    PubMed 41879224

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enlicitide Decanoate in people with Hypercholesterolemia and Familial Hypercholesterolemia, run by Merck Sharp & Dohme LLC at 168 sites in 14 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 4 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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 168 sites in United States, Japan, China, South Korea, Israel and 9 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Aug 2026). 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?

Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 (time frame: Baseline and Week 24). 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 NCT05952856, 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 24 Sep 2026.

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