A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)

February 5, 2026 updated by: Merck Sharp & Dohme LLC

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

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
303

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)
  • Brazil
      • São Paulo, Brazil, 05403-000
        • Incor - Instituto do Coracao ( Site 0703)
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-270
        • Universidade Federal Do Ceara ( Site 0702)
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04012-909
        • Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0701)
  • Canada
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21 ( Site 0510)
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal ( Site 0506)
      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Diex Recherche Trois-Rivieres ( Site 0513)
  • Chile
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5110683
        • Clinical Research Chile SpA ( Site 0804)
    • Region M. de Santiago
      • Providencia, Region M. de Santiago, Chile, 7500859
        • CDIEM ( Site 0814)
      • Santiago, Region M. de Santiago, Chile, 7500587
        • Enroll SpA ( Site 0803)
      • Santiago, Region M. de Santiago, Chile, 8330034
        • Pontificia Universidad Catolica de Chile-CICUC ( Site 0812)
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Fundación Centro de Investigación Clínica CIC ( Site 0906)
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 08001
        • Ciensalud Ips S A S ( Site 0903)
      • Barranquilla, Atlántico, Colombia, 080020
        • Clinica de la Costa S.A.S. ( Site 0902)
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 110231
        • Salud SURA Calle 100 ( Site 0918)
  • Czechia
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 625 00
        • Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)
    • Praha 4
      • Prague, Praha 4, Czechia, 140 21
        • Institut Klinicke a Experimentalni Mediciny ( Site 3601)
    • South Moravian
      • Brno, South Moravian, Czechia, 60200
        • Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)
  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)
  • Hong Kong
      • Pok Fu Lam, Hong Kong
        • Queen Mary Hospital-Medical ( Site 3300)
      • Shatin, Hong Kong, NT
        • Prince of Wales Hospital ( Site 3304)
  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6725
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)
  • Israel
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center ( Site 1710)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center ( Site 1709)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 1717)
      • Sakhnin, Israel, 308100
        • Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1700)
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboudumc-internal medicine ( Site 1952)
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)
      • Hoorn, North Holland, Netherlands, 1625 HV
        • Vasculair Onderzoek Centrum Hoorn ( Site 1953)
  • New Zealand
    • Bay of Plenty
      • Rotorua, Bay of Plenty, New Zealand, 3010
        • Pacific Clinical Research Network - Rotorua ( Site 2902)
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • New Zealand Clinical Research (Christchurch) ( Site 2901)
  • Norway
      • Oslo, Norway, 0316
        • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2000)
    • Nordland
      • Bodø, Nordland, Norway, 8005
        • Nordlandssykehuset ( Site 2001)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 119074
        • National University Hospital-Department of Medicine ( Site 3212)
      • Singapore, Central Singapore, Singapore, 529889
        • Changi General Hospital ( Site 3211)
  • Spain
    • Catalonia
      • Sant Joan Despí, Catalonia, Spain, 08970
        • Hospital de Sant Joan Despí Moisès Broggi ( Site 2335)
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • SALUT SANT JOAN DE REUS-BAIX CAMP (EDP)-Vascular and Metabolism Unit ( Site 2329)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • HOSPITAL CLINICO DE VALENCIA ( Site 2321)
  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital-Internal Medicine ( Site 3107)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 3100)
    • New Taipei
      • New Taipei City, New Taipei, Taiwan, 251
        • Mackay Memorial Hospital -Tamshui Branch ( Site 3109)
    • Taipei
      • Taipei City, Taipei, Taiwan, 111
        • Shin Kong Wu Ho-Su Memorial Hospital ( Site 3106)
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Alliance for Multispecialty Research, LLC ( Site 0023)
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials ( Site 0008)
      • Cutler Bay, Florida, United States, 33189
        • Advanced Pharma Research ( Site 0007)
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research ( Site 0021)
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Synexus Clinical Research US - Evansville ( Site 0031)
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Jubilee Clinical Research ( Site 0030)
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041)
    • Utah
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research, Salt Lake City ( Site 0004)
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc. ( Site 0020)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
  • Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
  • Is treated with a moderate- or high-intensity statin medication
  • Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change

Exclusion Criteria:

  • 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

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enlicitide Decanoate
Participants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
Drug: Enlicitide Decanoate
Oral tablet
Other Names:
  • MK-0616
Placebo Comparator: Placebo
Participants received enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
Drug: Placebo
Oral tablet (placebo).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
Time Frame: Baseline and Week 24
Blood samples were collected at baseline and at Week 24 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.
Baseline and Week 24
Number of Participants With Adverse Events (AEs)
Time Frame: Up to 64 weeks (8 weeks postdose)
An AE was defined as 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.
Up to 64 weeks (8 weeks postdose)
Number of Participants Who Discontinued Study Drug Due to an AE
Time Frame: Up to 56 weeks
An AE was defined as 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.
Up to 56 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline in LDL-C at Week 52
Time Frame: Baseline and Week 52
Blood samples were collected at baseline and at Week 52 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.
Baseline and Week 52
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
Time Frame: Baseline and Week 24
Blood samples were collected at baseline and at Week 24 to determine mean percent change in non-HDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline non-HDL-C as a covariate.
Baseline and Week 24
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
Time Frame: Baseline and Week 24
Blood samples were collected at baseline and at Week 24 to determine mean percent change in ApoB. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline ApoB as a covariate.
Baseline and Week 24
Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24
Time Frame: Baseline and Week 24
Blood samples were collected at baseline and at Week 24 to determine percent change in Lp(a). For percent change in Lp(a) at Week 24, the two treatment groups were analyzed using the Wilcoxon signed rank test with Hodges-Lehmann estimation.
Baseline and Week 24
Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24
Time Frame: Baseline and Week 24
Blood samples were collected at baseline and at Week 24 to determine the percentage of participants who had LDL-C <70 mg/dL and ≥50% reduction from baseline. The two treatment groups were analyzed based on the Miettinen and Nurminen method for the difference in percentage.
Baseline and Week 24
Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24
Time Frame: Baseline and Week 24
Blood samples were collected at baseline and at Week 24 to determine the percentage of participants who had LDL-C <55 mg/dL and ≥50% reduction from baseline. The two treatment groups were analyzed based on the Miettinen and Nurminen method for the difference in percentage.
Baseline and Week 24

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0616-017
  • MK-0616-017 (Other Identifier: MSD)
  • U1111-1285-4257 (Registry Identifier: UTN)
  • 2022-502782-14-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/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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