A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)

August 31, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia

Researchers designed a study medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C). In this study, researchers want to learn about giving enlicitide with another medicine called rosuvastatin. Rosuvastatin is a standard (usual) treatment to lower LDL-C.

The goal of this study is to learn if enlicitide given with rosuvastatin works better than placebo on lowering LDL-C in a person's blood. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

996

Phase

  • 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 Locations

  • Argentina
      • CABA, Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206)
      • Corrientes, Argentina, W3400AMZ
        • Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0205)
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1407GTL
        • CEMEDIC ( Site 0201)
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1061AAS
        • CIPREC-CIPREC Sede Arenales ( Site 0200)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000CVD
        • Fundacion Estudios Clinicos ( Site 0203)
      • Rosario, Santa Fe Province, Argentina, S2000CVD
        • Instituto de Investigaciones Clinicas Rosario ( Site 0204)
  • Australia
    • New South Wales
      • Maroubra, New South Wales, Australia, 2035
        • Australian Clinical Research Network ( Site 0900)
      • Sydney, New South Wales, Australia, 2010
        • Momentum Darlinghurst ( Site 0906)
    • Queensland
      • Taringa, Queensland, Australia, 4068
        • Momentum Clinical Research Taringa ( Site 0907)
    • South Australia
      • Norwood, South Australia, Australia, 5067
        • Fusion Clinical Research ( Site 0901)
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research ( Site 0904)
      • Hoppers Crossing, Victoria, Australia, 3029
        • Baker - HeartWest ( Site 0902)
  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-350
        • Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306)
    • Sergipe
      • Aracaju, Sergipe, Brazil, 49055-530
        • Centro de Pesquisa Clinica do Coracao ( Site 0303)
    • São Paulo
      • Bragança Paulista, São Paulo, Brazil, 12916-542
        • Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305)
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309)
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • G A Research Associates ( Site 0102)
    • Ontario
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research Inc. ( Site 0111)
      • North York, Ontario, Canada, M6B 3H7
        • North York Diagnostic and Cardiac Centre ( Site 0110)
      • Thunder Bay, Ontario, Canada, P7B 7C7
        • Care Access - Thunder Bay ( Site 0130)
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Centricity Research Mirabel Multispecialty ( Site 0107)
      • Québec, Quebec, Canada, G1G 5X1
        • Recherche Clinique Sigma Inc ( Site 0108)
  • Hungary
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102)
    • Bács-Kiskun county
      • Baja, Bács-Kiskun county, Hungary, 6500
        • Lausmed Egészségügyi Szolgáltató ( Site 1105)
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4405
        • Borbánya Praxis ( Site 1103)
    • Veszprém megye
      • Balatonfüred, Veszprém megye, Hungary, 8230
        • DRC Gyógyszervizsgáló Központ ( Site 1109)
  • Israel
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center ( Site 0504)
      • Haifa, Israel, 3100000
        • Linn Medical Center ( Site 0503)
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus ( Site 0500)
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center. ( Site 0501)
      • Sakhnin, Israel, 3081000
        • Clalit Health Services - Sakhnin Community Clinic ( Site 0502)
  • New Zealand
    • Bay of Plenty
      • Rotorua, Bay of Plenty, New Zealand, 3010
        • Pacific Clinical Research Network - Rotorua ( Site 1001)
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8013
        • Pacific Clinical Research Network - Forte ( Site 1004)
    • Tasman District
      • Nelson, Tasman District, New Zealand, 7011
        • Pacific Clinical Research Network - Tasman ( Site 1003)
    • Waikato Region
      • Nawton, Waikato Region, New Zealand, 3200
        • Lakeland Clinical Trials Waikato ( Site 1000)
    • Wellington Region
      • Upper Hutt, Wellington Region, New Zealand, 5018
        • Lakeland Clinical Trials Wellington ( Site 1002)
  • Spain
      • Barcelona, Spain, 08025
        • EAP Sardenya ( Site 0601)
      • Barcelona, Spain, 08540
        • EBA Centelles ( Site 0600)
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15701
        • Centro de Salud Concepcion Arenal ( Site 0603)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06520
        • Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)
      • Eskişehir, Turkey (Türkiye), 26480
        • Eskisehir Osmangazi University ( Site 0705)
      • Istanbul, Turkey (Türkiye), 34080
        • Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)
      • Kayseri, Turkey (Türkiye), 38030
        • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)
      • Malatya, Turkey (Türkiye), 44280
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)
    • Ankara
      • Sıhhiye, Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universite Hastaneleri ( Site 0700)
  • United Kingdom
    • Bristol, City of
      • Bristol, Bristol, City of, United Kingdom, BS8 2RA
        • Velocity Clinical Research Romford ( Site 0803)
    • Gloucestershire
      • Yate, Gloucestershire, United Kingdom, BS37 4AX
        • West Walk Surgery ( Site 0801)
    • Havering
      • London, Havering, United Kingdom, RM1 3PJ
        • Velocity Clinical Research Havering ( Site 0804)
    • London, City of
      • London, London, City of, United Kingdom, EC1M 6BQ
        • William Harvey Heart Centre ( Site 0800)
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN17 2UR
        • Lakeside Surgery ( Site 0802)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates ( Site 0009)
      • Foley, Alabama, United States, 36535
        • G&L Research ( Site 0024)
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
      • Tempe, Arizona, United States, 85281
        • Alliance for Multispecialty Research LLC ( Site 0049)
    • California
      • Lancaster, California, United States, 93534
        • Chemidox Clinical Trials ( Site 0008)
      • Sacramento, California, United States, 95821
        • Clinical Trials Research ( Site 0036)
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Legacy Clinical Trials ( Site 0044)
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Alliance for Multispecialty Research, LLC ( Site 0040)
      • Hollywood, Florida, United States, 33020
        • Soffer Health Institute ( Site 0046)
      • Lake City, Florida, United States, 32055
        • East Coast Institute for Research ( Site 0041)
      • Miami Lakes, Florida, United States, 33014
        • Inpatient Research Clinic ( Site 0017)
      • Tampa, Florida, United States, 33607
        • Clinical Research Trials of Florida ( Site 0001)
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Trialmed ( Site 0026)
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials - Ravenswood ( Site 0018)
    • Indiana
      • Indianapolis, Indiana, United States, 46260-5310
        • Midwest Institute For Clinical Research ( Site 0033)
    • Kansas
      • Newton, Kansas, United States, 67114
        • Alliance for Multispecialty Research, LLC ( Site 0048)
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center ( Site 0006)
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center ( Site 0004)
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Jubilee Clinical Research ( Site 0031)
    • New Jersey
      • Elmer, New Jersey, United States, 08318
        • Cardiovascular Associates of the Delaware Valley ( Site 0035)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-4725
        • New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Alliance for Multispecialty Research, LLC - Norman ( Site 0043)
    • Pennsylvania
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia Yardley ( Site 0016)
    • Texas
      • Houston, Texas, United States, 77027
        • Provecta Research Network LLC ( Site 0022)
      • Odessa, Texas, United States, 79761
        • Permian Research Foundation ( Site 0005)
      • Pearland, Texas, United States, 77584
        • LinQ Research ( Site 0025)
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc. ( Site 0010)
      • San Antonio, Texas, United States, 78258
        • Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)
      • Tomball, Texas, United States, 77375
        • LinQ Research - Tomball ( Site 0047)
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Conquest Research ( Site 0045)
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center ( Site 0002)
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc. ( Site 0013)
      • Richmond, Virginia, United States, 23294
        • National Clinical Research, Inc ( Site 0028)
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research ( Site 0023)

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.

Exclusion Criteria:

  • Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH.
  • Had a heart failure hospitalization within 3 months before Screening.
  • Is unwilling to take a statin, and/or has a history of statin-associated muscle symptoms or other statin-related AEs to any statin and dose, and/or is known to be intolerant to 1 or more statins.
  • Has a history of any of the following conditions: (1) Myopathy, myositis, rhabdomyolysis, or unexplained muscle pain; (2) Muscular or neuromuscular disease; (3) Neuropathy, fibromyalgia, or chronic pain; or (4) Has a personal or family history of hereditary muscular disorders.
  • Has active or chronic hepatobiliary or hepatic disease.
  • Has known human immunodeficiency virus (HIV) infection.
  • Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Screening or plans to initiate an LDL-C apheresis program.
  • Has received any medication that may interact with rosuvastatin within 5 half-lives prior to Screening or is planning to initiate such treatment.

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: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enlicitide
Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
Drug: Enlicitide
Oral Tablet
Other Names:
  • MK-0616
  • Enlicitide decanoate
Drug: Placebo for Rosuvastatin
Oral Capsule
Experimental: Enlicitide + Rosuvastatin
Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
Drug: Enlicitide
Oral Tablet
Other Names:
  • MK-0616
  • Enlicitide decanoate
Drug: Rosuvastatin
Oral Capsule
Active Comparator: Rosuvastatin
Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
Drug: Rosuvastatin
Oral Capsule
Drug: Placebo for Enlicitide
Oral Tablet
Placebo Comparator: Placebo
Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.
Drug: Placebo for Rosuvastatin
Oral Capsule
Drug: Placebo for Enlicitide
Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C between participants treated with enlicitide and rosuvastatin versus placebo.
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change from Baseline in LDL-C at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C.
Baseline and Week 8
Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in ApoB.
Baseline and Week 8
Number of Participants with One or More Adverse Events (AEs)
Time Frame: Up to approximately 20 weeks
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.
Up to approximately 20 weeks
Number of Participants who Discontinue Study Drug Due to One or More AEs
Time Frame: Up to approximately 12 weeks
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.
Up to approximately 12 weeks
Mean Percent Change from Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
Blood samples will be collected at baseline and at Week 12 to assess mean percent change in LDL-C.
Baseline and Week 12
Mean Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in non-HDL-C.
Baseline and Week 8
Percent Change from Baseline in Lipoprotein (a) (Lp[a]) at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess percent change in Lp(a).
Baseline and Week 8
Percentage of Participants with LDL-C <70 mg/dL and ≥50% Reduction from Baseline at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline.
Baseline and Week 8
Percentage of Participants with LDL-C <55 mg/dL and ≥50% Reduction from Baseline at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline.
Baseline and Week 8

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • 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.

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)

November 11, 2025

Primary Completion (Actual)

August 3, 2026

Study Completion (Estimated)

November 5, 2026

Study Registration Dates

First Submitted

October 10, 2025

First Submitted That Met QC Criteria

October 10, 2025

First Posted (Actual)

October 14, 2025

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0616-037
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • U1111-1319-9502 (Registry Identifier: UTN)
  • 2025-521495-54-00 (Registry Identifier: EU CT)
  • MK-0616-037 (Other Identifier: MSD)

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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