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RECRUITING
NCT07216482
PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

975

Start Date

2025-11-11

Completion Date

2027-03-01

Last Updated

2026-04-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Enlicitide

Oral Tablet

DRUG

Rosuvastatin

Oral Capsule

DRUG

Placebo for Enlicitide

Oral Tablet

DRUG

Placebo for Rosuvastatin

Oral Capsule

Locations (88)

Central Research Associates ( Site 0009)

Birmingham, Alabama, United States

G&L Research ( Site 0024)

Foley, Alabama, United States

Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)

Phoenix, Arizona, United States

Alliance for Multispecialty Research LLC ( Site 0049)

Tempe, Arizona, United States

Chemidox Clinical Trials ( Site 0008)

Lancaster, California, United States

Clinical Trials Research ( Site 0036)

Sacramento, California, United States

Legacy Clinical Trials ( Site 0044)

Colorado Springs, Colorado, United States

Alliance for Multispecialty Research, LLC ( Site 0040)

Fort Myers, Florida, United States

Soffer Health Institute ( Site 0046)

Hollywood, Florida, United States

East Coast Institute for Research ( Site 0041)

Lake City, Florida, United States

Inpatient Research Clinic ( Site 0017)

Miami Lakes, Florida, United States

Clinical Research Trials of Florida ( Site 0001)

Tampa, Florida, United States

Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)

Winter Park, Florida, United States

Trialmed ( Site 0026)

Chicago, Illinois, United States

Great Lakes Clinical Trials - Ravenswood ( Site 0018)

Chicago, Illinois, United States

Midwest Institute For Clinical Research ( Site 0033)

Indianapolis, Indiana, United States

Alliance for Multispecialty Research, LLC ( Site 0048)

Newton, Kansas, United States

Cotton O'Neil Clinical Research Center ( Site 0006)

Topeka, Kansas, United States

L-MARC Research Center ( Site 0004)

Louisville, Kentucky, United States

Jubilee Clinical Research ( Site 0031)

Las Vegas, Nevada, United States

Cardiovascular Associates of the Delaware Valley ( Site 0035)

Elmer, New Jersey, United States

New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)

Albuquerque, New Mexico, United States

Alliance for Multispecialty Research, LLC - Norman ( Site 0043)

Norman, Oklahoma, United States

Cardiology Consultants of Philadelphia Yardley ( Site 0016)

Yardley, Pennsylvania, United States

Provecta Research Network LLC ( Site 0022)

Houston, Texas, United States

Permian Research Foundation ( Site 0005)

Odessa, Texas, United States

LinQ Research ( Site 0025)

Pearland, Texas, United States

Clinical Trials of Texas, Inc. ( Site 0010)

San Antonio, Texas, United States

Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)

San Antonio, Texas, United States

LinQ Research - Tomball ( Site 0047)

Tomball, Texas, United States

Conquest Research ( Site 0045)

Arlington, Virginia, United States

Manassas Clinical Research Center ( Site 0002)

Manassas, Virginia, United States

Health Research of Hampton Roads, Inc. ( Site 0013)

Newport News, Virginia, United States

National Clinical Research, Inc ( Site 0028)

Richmond, Virginia, United States

Rainier Clinical Research ( Site 0023)

Renton, Washington, United States

CEMEDIC ( Site 0201)

CABA, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)

Mar del Plata, Buenos Aires, Argentina

CIPREC-CIPREC Sede Arenales ( Site 0200)

Buenos Aires, Buenos Aires F.D., Argentina

Fundacion Estudios Clinicos ( Site 0203)

Rosario, Santa Fe Province, Argentina

Instituto de Investigaciones Clinicas Rosario ( Site 0204)

Rosario, Santa Fe Province, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206)

CABA, Argentina

Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0205)

Corrientes, Argentina

Australian Clinical Research Network ( Site 0900)

Maroubra, New South Wales, Australia

Momentum Darlinghurst ( Site 0906)

Sydney, New South Wales, Australia

Momentum Clinical Research Taringa ( Site 0907)

Taringa, Queensland, Australia

Fusion Clinical Research ( Site 0901)

Norwood, South Australia, Australia

Emeritus Research ( Site 0904)

Camberwell, Victoria, Australia

Baker - HeartWest ( Site 0902)

Hoppers Crossing, Victoria, Australia

Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306)

Fortaleza, Ceará, Brazil

Centro de Pesquisa Clinica do Coracao ( Site 0303)

Aracaju, Sergipe, Brazil

Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305)

Bragança Paulista, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309)

São José do Rio Preto, São Paulo, Brazil

IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)

Rio de Janeiro, Brazil

G A Research Associates ( Site 0102)

Moncton, New Brunswick, Canada

Milestone Research Inc. ( Site 0111)

London, Ontario, Canada

North York Diagnostic and Cardiac Centre ( Site 0110)

North York, Ontario, Canada

Care Access - Thunder Bay ( Site 0130)

Thunder Bay, Ontario, Canada

Centricity Research Mirabel Multispecialty ( Site 0107)

Mirabel, Quebec, Canada

Recherche Clinique Sigma Inc ( Site 0108)

Québec, Quebec, Canada

Lausmed Egészségügyi Szolgáltató ( Site 1105)

Baja, Bács-Kiskun county, Hungary

Borbánya Praxis ( Site 1103)

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

DRC Gyógyszervizsgáló Központ ( Site 1109)

Balatonfüred, Veszprém megye, Hungary

Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102)

Debrecen, Hungary

Barzilai Medical Center ( Site 0504)

Ashkelon, Israel

Linn Medical Center ( Site 0503)

Haifa, Israel

Rambam Health Care Campus ( Site 0500)

Haifa, Israel

Meir Medical Center. ( Site 0501)

Kfar Saba, Israel

Clalit Health Services - Sakhnin Community Clinic ( Site 0502)

Sakhnin, Israel

Pacific Clinical Research Network - Rotorua ( Site 1001)

Rotorua, Bay of Plenty, New Zealand

Pacific Clinical Research Network - Forte ( Site 1004)

Christchurch, Canterbury, New Zealand

Pacific Clinical Research Network - Tasman ( Site 1003)

Nelson, Tasman District, New Zealand

Lakeland Clinical Trials Waikato ( Site 1000)

Nawton, Waikato Region, New Zealand

Lakeland Clinical Trials Wellington ( Site 1002)

Upper Hutt, Wellington Region, New Zealand

Centro de Salud Concepcion Arenal ( Site 0603)

Santiago de Compostela, Galicia, Spain

EAP Sardenya ( Site 0601)

Barcelona, Spain

EBA Centelles ( Site 0600)

Barcelona, Spain

Hacettepe Universite Hastaneleri ( Site 0700)

Sıhhiye, Ankara, Turkey (Türkiye)

Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)

Ankara, Turkey (Türkiye)

Eskisehir Osmangazi University ( Site 0705)

Eskişehir, Turkey (Türkiye)

Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)

Istanbul, Turkey (Türkiye)

Ege Universitesi Hastanesi ( Site 0708)

Izmir, Turkey (Türkiye)

Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)

Kayseri, Turkey (Türkiye)

İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)

Malatya, Turkey (Türkiye)

Velocity Clinical Research, Bristol ( Site 0803)

Bristol, Bristol, City of, United Kingdom

West Walk Surgery ( Site 0801)

Yate, Gloucestershire, United Kingdom

Velocity Clinical Research Havering ( Site 0804)

London, Havering, United Kingdom

William Harvey Heart Centre ( Site 0800)

London, London, City of, United Kingdom

Lakeside Surgery ( Site 0802)

Corby, Northamptonshire, United Kingdom