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HypercholesterolemiaPhase 3NCT05952869

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

A Phase 3 study testing Enlicitide Decanoate in people with Hypercholesterolemia and Familial Hypercholesterolemia, run by Merck Sharp & Dohme LLC at 59 sites in 17 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 heterozygous familial hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein… 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
303 participants
Where
59 sitesin 17 countries
Study dates
8 Aug 2023to 7 Apr 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 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

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

Trial locations and contacts

59 sites in 17 countries.

59 sites in 17 countries

United States13 sites

  • Excel Medical Clinical Trials ( Site 0008)

    Boca Raton, Florida, 33434

  • Advanced Pharma Research ( Site 0007)

    Cutler Bay, Florida, 33189

  • Alliance for Multispecialty Research, LLC ( Site 0023)

    Daphne, Alabama, 36526

  • Synexus Clinical Research US - Evansville ( Site 0031)

    Evansville, Indiana, 47714

  • Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)

    Indianapolis, Indiana, 46237

  • Jubilee Clinical Research ( Site 0030)

    Las Vegas, Nevada, 89106

  • Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)

    Lincoln, Nebraska, 68506

  • Health Research of Hampton Roads, Inc. ( Site 0020)

    Newport News, Virginia, 23606

  • Progressive Medical Research ( Site 0021)

    Port Orange, Florida, 32127

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)

    Troy, Michigan, 48098

  • Velocity Clinical Research, Salt Lake City ( Site 0004)

    West Jordan, Utah, 84088

  • Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041)

    Winston-Salem, North Carolina, 27157

  • Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)

    Winter Park, Florida, 32789

Other trials in United States

Chile4 sites

  • CDIEM ( Site 0814)

    Providencia, Region M. de Santiago, 7500859

  • Enroll SpA ( Site 0803)

    Santiago, Region M. de Santiago, 7500587

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 0812)

    Santiago, Region M. de Santiago, 8330034

  • Clinical Research Chile SpA ( Site 0804)

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

Colombia4 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 Centro de Investigación Clínica CIC ( Site 0906)

    Medellín, Antioquia, 050021

Other trials in Colombia

Israel4 sites

  • Shaare Zedek Medical Center ( Site 1710)

    Jerusalem, 9103102

  • Hadassah Medical Center ( Site 1709)

    Jerusalem, 9112001

  • Rabin Medical Center ( Site 1717)

    Petah Tikva, 4941492

  • Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1700)

    Sakhnin, 308100

Other trials in Israel

Netherlands4 sites

  • Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)

    Amsterdam, North Holland, 1105 AZ

  • Vasculair Onderzoek Centrum Hoorn ( Site 1953)

    Hoorn, North Holland, 1625 HV

  • Radboudumc-internal medicine ( Site 1952)

    Nijmegen, Gelderland, 6525 GA

  • Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)

    Utrecht, 3584 CX

Other trials in Netherlands

Taiwan4 sites

  • Mackay Memorial Hospital -Tamshui Branch ( Site 3109)

    New Taipei City, New Taipei, 251

  • National Cheng Kung University Hospital-Internal Medicine ( Site 3107)

    Tainan, 704

  • National Taiwan University Hospital ( Site 3100)

    Taipei, 10002

  • Shin Kong Wu Ho-Su Memorial Hospital ( Site 3106)

    Taipei City, Taipei, 111

Other trials in Taiwan

Brazil3 sites

  • Universidade Federal Do Ceara ( Site 0702)

    Fortaleza, Ceará, 60430-270

  • Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0701)

    São Paulo, São Paulo, 04012-909

  • Incor - Instituto do Coracao ( Site 0703)

    São Paulo, 05403-000

Other trials in Brazil

Canada3 sites

  • Ecogene-21 ( Site 0510)

    Chicoutimi, Quebec, G7H 7K9

  • Institut de Cardiologie de Montreal ( Site 0506)

    Montreal, Quebec, H1T 1C8

  • Diex Recherche Trois-Rivieres ( Site 0513)

    Trois-Rivières, Quebec, G9A 4P3

Other trials in Canada

Czechia3 sites

  • Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)

    Brno, Brno-mesto, 625 00

  • Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)

    Brno, South Moravian, 60200

  • Institut Klinicke a Experimentalni Mediciny ( Site 3601)

    Prague, Praha 4, 140 21

Other trials in Czechia

Hungary3 sites

  • Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)

    Debrecen, 4032

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Spain3 sites

  • SALUT SANT JOAN DE REUS-BAIX CAMP (EDP)-Vascular and Metabolism Unit ( Site 2329)

    Reus, Tarragona, 43204

  • Hospital de Sant Joan Despí Moisès Broggi ( Site 2335)

    Sant Joan Despí, Catalonia, 08970

  • HOSPITAL CLINICO DE VALENCIA ( Site 2321)

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

Australia2 sites

  • Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)

    Camperdown, New South Wales, 2050

  • Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)

    Clayton, Victoria, 3168

Other trials in Australia

Hong Kong2 sites

  • Queen Mary Hospital-Medical ( Site 3300)

    Pok Fu Lam

  • Prince of Wales Hospital ( Site 3304)

    Shatin, NT

Other trials in Hong Kong

New Zealand2 sites

  • New Zealand Clinical Research (Christchurch) ( Site 2901)

    Christchurch, Canterbury, 8011

  • Pacific Clinical Research Network - Rotorua ( Site 2902)

    Rotorua, Bay of Plenty, 3010

Other trials in New Zealand

Norway2 sites

  • Nordlandssykehuset ( Site 2001)

    Bodø, Nordland, 8005

  • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2000)

    Oslo, 0316

Other trials in Norway

Singapore2 sites

  • National University Hospital-Department of Medicine ( Site 3212)

    Singapore, Central Singapore, 119074

  • Changi General Hospital ( Site 3211)

    Singapore, Central Singapore, 529889

Other trials in Singapore

Finland1 site

  • Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)

    Helsinki, Uusimaa, 00290

Other trials in Finland

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 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.

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 (placebo).

Study groups in NCT05952869
Study groupRoleWhat they receive
Enlicitide DecanoateExperimentalParticipants received 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.
Receives: Drug: Enlicitide Decanoate
PlaceboPlacebo comparatorParticipants received 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 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.

    Measured: Baseline and Week 24

  2. Number of Participants With Adverse Events (AEs)

    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.

    Measured: Up to 64 weeks (8 weeks postdose)

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

    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.

    Measured: Up to 56 weeks

Secondary outcomes (6)

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

    Measured: Baseline and Week 52

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

    Measured: Baseline and Week 24

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

    Measured: Baseline and Week 24

  4. Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at 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.

    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 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.

    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 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.

    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 start8 Aug 2023
  3. Primary completion7 Apr 2025
  4. Study completion7 Apr 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
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05952869
Sponsor's protocol ID
0616-017
Other IDs
MK-0616-017, 2022-502782-14-00, U1111-1285-4257
Status last verified
Feb 2026
First submitted
10 Jul 2023
Last updated
24 Feb 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

  • Ballantyne CM, Gellis L, Tardif JC, Banka P, Navar AM, Asprusten EA, Scott R, Stroes ESG, Froman S, Mendizabal G, Wang F, Catapano AL. Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial. JAMA. 2026 Jan 13;335(2):129-139. doi: 10.1001/jama.2025.20620.

    PubMed 41206969

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 59 sites in 17 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 4 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 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Chile, Colombia, Israel, Netherlands and 12 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 24 Feb 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 NCT05952869, 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 Feb 2026.

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