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

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: Recruiting
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: Enlicitide; Drug: Placebo for Rosuvastatin; Drug: Rosuvastatin; Drug: Placebo for Enlicitide

• Study Type: Interventional
• Enrollment (Estimated): 975
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Toll Free Number; Phone Number: 1-888-577-8839; Email: Trialsites@msd.com

Study Locations

• Argentina
  • CABA, Argentina, C1425AGC
    • Active, not recruiting
    • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206)
  • Corrientes, Argentina, W3400AMZ
    • Active, not recruiting
    • Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0205)
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1407GTL
      • Active, not recruiting
      • CEMEDIC ( Site 0201)
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Active, not recruiting
      • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1061AAS
      • Active, not recruiting
      • CIPREC-CIPREC Sede Arenales ( Site 0200)
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000CVD
      • Active, not recruiting
      • Fundacion Estudios Clinicos ( Site 0203)
    • Rosario, Santa Fe Province, Argentina, S2000CVD
      • Active, not recruiting
      • Instituto de Investigaciones Clinicas Rosario ( Site 0204)
• Australia
  • New South Wales
    • Maroubra, New South Wales, Australia, 2035
      • Active, not recruiting
      • Australian Clinical Research Network ( Site 0900)
    • Sydney, New South Wales, Australia, 2010
      • Active, not recruiting
      • Momentum Darlinghurst ( Site 0906)
  • Queensland
    • Taringa, Queensland, Australia, 4068
      • Active, not recruiting
      • Momentum Clinical Research Taringa ( Site 0907)
  • South Australia
    • Norwood, South Australia, Australia, 5067
      • Active, not recruiting
      • Fusion Clinical Research ( Site 0901)
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Active, not recruiting
      • Emeritus Research ( Site 0904)
    • Hoppers Crossing, Victoria, Australia, 3029
      • Active, not recruiting
      • Baker - HeartWest ( Site 0902)
• Brazil
  • Rio de Janeiro, Brazil, 20241-180
    • Recruiting
    • IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)
    • Contact: Study Coordinator; Phone Number: +552125277979
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-350
      • Recruiting
      • Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306)
      • Contact: Study Coordinator; Phone Number: +55 85 996299242
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49055-530
      • Recruiting
      • Centro de Pesquisa Clinica do Coracao ( Site 0303)
      • Contact: Study Coordinator; Phone Number: +557930259700
  • São Paulo
    • Bragança Paulista, São Paulo, Brazil, 12916-542
      • Active, not recruiting
      • Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305)
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Recruiting
      • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309)
      • Contact: Study Coordinator; Phone Number: +55173201-5054
• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Active, not recruiting
      • G A Research Associates ( Site 0102)
  • Ontario
    • London, Ontario, Canada, N5W 6A2
      • Active, not recruiting
      • Milestone Research Inc. ( Site 0111)
    • North York, Ontario, Canada, M6B 3H7
      • Recruiting
      • North York Diagnostic and Cardiac Centre ( Site 0110)
      • Contact: Study Coordinator; Phone Number: 416-783-0000
    • Thunder Bay, Ontario, Canada, P7B 7C7
      • Recruiting
      • Care Access - Thunder Bay ( Site 0130)
      • Contact: Study Coordinator; Phone Number: 8076955220
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Active, not recruiting
      • Centricity Research Mirabel Multispecialty ( Site 0107)
    • Montreal, Quebec, Canada, H1T 1C8
      • Recruiting
      • Institut de Cardiologie de Montreal ( Site 0109)
      • Contact: Study Coordinator; Phone Number: 514-376-3330
    • Québec, Quebec, Canada, G1G 5X1
      • Active, not recruiting
      • Recherche Clinique Sigma Inc ( Site 0108)
• Hungary
  • Debrecen, Hungary, 4032
    • Active, not recruiting
    • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102)
  • Bács-Kiskun county
    • Baja, Bács-Kiskun county, Hungary, 6500
      • Active, not recruiting
      • Lausmed Egészségügyi Szolgáltató ( Site 1105)
  • Szabolcs-Szatmár-Bereg
    • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4405
      • Active, not recruiting
      • Borbánya Praxis ( Site 1103)
  • Veszprém megye
    • Balatonfüred, Veszprém megye, Hungary, 8230
      • Active, not recruiting
      • DRC Gyógyszervizsgáló Központ ( Site 1109)
• Israel
  • Ashkelon, Israel, 7830604
    • Active, not recruiting
    • Barzilai Medical Center ( Site 0504)
  • Haifa, Israel, 3100000
    • Active, not recruiting
    • Linn Medical Center ( Site 0503)
  • Haifa, Israel, 3109601
    • Active, not recruiting
    • Rambam Health Care Campus ( Site 0500)
  • Kfar Saba, Israel, 4428164
    • Active, not recruiting
    • Meir Medical Center. ( Site 0501)
  • Sakhnin, Israel, 3081000
    • Active, not recruiting
    • Clalit Health Services - Sakhnin Community Clinic ( Site 0502)
• New Zealand
  • Bay of Plenty
    • Rotorua, Bay of Plenty, New Zealand, 3010
      • Active, not recruiting
      • Pacific Clinical Research Network - Rotorua ( Site 1001)
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8013
      • Active, not recruiting
      • Pacific Clinical Research Network - Forte ( Site 1004)
  • Tasman District
    • Nelson, Tasman District, New Zealand, 7011
      • Active, not recruiting
      • Pacific Clinical Research Network - Tasman ( Site 1003)
  • Waikato Region
    • Nawton, Waikato Region, New Zealand, 3200
      • Active, not recruiting
      • Lakeland Clinical Trials Waikato ( Site 1000)
  • Wellington Region
    • Upper Hutt, Wellington Region, New Zealand, 5018
      • Active, not recruiting
      • Lakeland Clinical Trials Wellington ( Site 1002)
• Spain
  • Barcelona, Spain, 08540
    • Active, not recruiting
    • EBA Centelles ( Site 0600)
  • Barcelona, Spain, 08025
    • Active, not recruiting
    • EAP Sardenya ( Site 0601)
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15701
      • Active, not recruiting
      • Centro de Salud Concepcion Arenal ( Site 0603)
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06520
    • Active, not recruiting
    • Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)
  • Eskişehir, Turkey (Türkiye), 26480
    • Active, not recruiting
    • Eskisehir Osmangazi University ( Site 0705)
  • Istanbul, Turkey (Türkiye), 34080
    • Active, not recruiting
    • Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)
  • Izmir, Turkey (Türkiye), 35080
    • Active, not recruiting
    • Ege Universitesi Hastanesi ( Site 0708)
  • Kayseri, Turkey (Türkiye), 38030
    • Active, not recruiting
    • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)
  • Malatya, Turkey (Türkiye), 44280
    • Active, not recruiting
    • İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)
  • Ankara
    • Sıhhiye, Ankara, Turkey (Türkiye), 06230
      • Active, not recruiting
      • Hacettepe Universite Hastaneleri ( Site 0700)
• United Kingdom
  • Bristol, City of
    • Bristol, Bristol, City of, United Kingdom, BS8 2RA
      • Active, not recruiting
      • Velocity Clinical Research, Bristol ( Site 0803)
  • Gloucestershire
    • Yate, Gloucestershire, United Kingdom, BS37 4AX
      • Active, not recruiting
      • West Walk Surgery ( Site 0801)
  • Havering
    • London, Havering, United Kingdom, RM1 3PJ
      • Active, not recruiting
      • Velocity Clinical Research Havering ( Site 0804)
  • London, City of
    • London, London, City of, United Kingdom, EC1M 6BQ
      • Active, not recruiting
      • William Harvey Heart Centre ( Site 0800)
  • Northamptonshire
    • Corby, Northamptonshire, United Kingdom, NN17 2UR
      • Active, not recruiting
      • Lakeside Surgery ( Site 0802)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Active, not recruiting
      • Central Research Associates ( Site 0009)
    • Foley, Alabama, United States, 36535
      • Active, not recruiting
      • G&L Research ( Site 0024)
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Active, not recruiting
      • Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
    • Tempe, Arizona, United States, 85281
      • Active, not recruiting
      • Alliance for Multispecialty Research LLC ( Site 0049)
  • California
    • Lancaster, California, United States, 93534
      • Active, not recruiting
      • Chemidox Clinical Trials ( Site 0008)
    • Sacramento, California, United States, 95821
      • Active, not recruiting
      • Clinical Trials Research ( Site 0036)
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Active, not recruiting
      • Legacy Clinical Trials ( Site 0044)
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Active, not recruiting
      • Alliance for Multispecialty Research, LLC ( Site 0040)
    • Hollywood, Florida, United States, 33020
      • Active, not recruiting
      • Soffer Health Institute ( Site 0046)
    • Lake City, Florida, United States, 32055
      • Active, not recruiting
      • East Coast Institute for Research ( Site 0041)
    • Miami Lakes, Florida, United States, 33014
      • Active, not recruiting
      • Inpatient Research Clinic ( Site 0017)
    • Tampa, Florida, United States, 33607
      • Active, not recruiting
      • Clinical Research Trials of Florida ( Site 0001)
    • Winter Park, Florida, United States, 32789
      • Active, not recruiting
      • Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Active, not recruiting
      • Trialmed ( Site 0026)
    • Chicago, Illinois, United States, 60640
      • Active, not recruiting
      • Great Lakes Clinical Trials - Ravenswood ( Site 0018)
  • Indiana
    • Indianapolis, Indiana, United States, 46260-5310
      • Active, not recruiting
      • Midwest Institute For Clinical Research ( Site 0033)
  • Kansas
    • Newton, Kansas, United States, 67114
      • Active, not recruiting
      • Alliance for Multispecialty Research, LLC ( Site 0048)
    • Topeka, Kansas, United States, 66606
      • Active, not recruiting
      • Cotton O'Neil Clinical Research Center ( Site 0006)
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Active, not recruiting
      • Monroe Biomedical Research ( Site 0004)
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Active, not recruiting
      • Jubilee Clinical Research ( Site 0031)
  • New Jersey
    • Elmer, New Jersey, United States, 08318
      • Active, not recruiting
      • Cardiovascular Associates of the Delaware Valley ( Site 0035)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106-4725
      • Active, not recruiting
      • New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Active, not recruiting
      • Alliance for Multispecialty Research, LLC - Norman ( Site 0043)
  • Pennsylvania
    • Yardley, Pennsylvania, United States, 19067
      • Active, not recruiting
      • Cardiology Consultants of Philadelphia Yardley ( Site 0016)
  • Texas
    • Houston, Texas, United States, 77027
      • Recruiting
      • Provecta Research Network LLC ( Site 0022)
      • Contact: Study Coordinator; Phone Number: 346-735-8990
    • Odessa, Texas, United States, 79761
      • Active, not recruiting
      • Permian Research Foundation ( Site 0005)
    • Pearland, Texas, United States, 77584
      • Active, not recruiting
      • LinQ Research ( Site 0025)
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Clinical Trials of Texas, Inc. ( Site 0010)
      • Contact: Study Coordinator; Phone Number: 210-949-0122
    • San Antonio, Texas, United States, 78258
      • Active, not recruiting
      • Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)
    • Tomball, Texas, United States, 77375
      • Active, not recruiting
      • LinQ Research - Tomball ( Site 0047)
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Active, not recruiting
      • Manassas Clinical Research Center ( Site 0002)
    • Newport News, Virginia, United States, 23606
      • Active, not recruiting
      • Health Research of Hampton Roads, Inc. ( Site 0013)
    • Richmond, Virginia, United States, 23294
      • Active, not recruiting
      • National Clinical Research, Inc ( Site 0028)
    • Vienna, Virginia, United States, 22182
      • Active, not recruiting
      • Conquest Research ( Site 0045)
  • Washington
    • Renton, Washington, United States, 98057
      • Active, not recruiting
      • Rainier Clinical Research ( Site 0023)

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

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)	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	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	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)	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	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	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	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	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	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	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

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2025
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): March 1, 2027

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): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hyperlipidemias; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Rosuvastatin Calcium; MK-0616
• Other Study ID Numbers: 0616-037; 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