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NCT07216482Active, not recruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
996 (actual)
First submitted
10 Oct 2025
Start date
11 Nov 2025
Primary completion date
3 Aug 2026
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT07216482
EU CT number
2025-521495-54-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 996
  • From 11 Nov 2025 to the primary completion date, 3 Aug 2026
  • 87 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Had a heart failure hospitalization within 3 months before Screening.
  • 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.

Other illness

  • Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH.
  • 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.

Who the study is looking for

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

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (87)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CIPREC-CIPREC Sede Arenales ( Site 0200)
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Buenos AiresArgentinaUnknown status
CEMEDIC ( Site 0201)
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CABAArgentinaUnknown status
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206)
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CABAArgentinaUnknown status
Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0205)
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CorrientesArgentinaUnknown status
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)
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Mar del PlataArgentinaUnknown status
Instituto de Investigaciones Clinicas Rosario ( Site 0204)
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RosarioArgentinaUnknown status
Fundacion Estudios Clinicos ( Site 0203)
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RosarioArgentinaUnknown status
Emeritus Research ( Site 0904)
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CamberwellAustraliaUnknown status
Baker - HeartWest ( Site 0902)
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Hoppers CrossingAustraliaUnknown status
Australian Clinical Research Network ( Site 0900)
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MaroubraAustraliaUnknown status
Fusion Clinical Research ( Site 0901)
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NorwoodAustraliaUnknown status
Momentum Darlinghurst ( Site 0906)
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SydneyAustraliaUnknown status
Momentum Clinical Research Taringa ( Site 0907)
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TaringaAustraliaUnknown status
Centro de Pesquisa Clinica do Coracao ( Site 0303)
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AracajuBrazilUnknown status
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305)
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Bragança PaulistaBrazilUnknown status
Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306)
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FortalezaBrazilUnknown status
IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)
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Rio de JaneiroBrazilUnknown status
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309)
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São José do Rio PretoBrazilUnknown status
Milestone Research Inc. ( Site 0111)
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LondonCanadaUnknown status
Centricity Research Mirabel Multispecialty ( Site 0107)
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MirabelCanadaUnknown status
G A Research Associates ( Site 0102)
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MonctonCanadaUnknown status
North York Diagnostic and Cardiac Centre ( Site 0110)
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North YorkCanadaUnknown status
Recherche Clinique Sigma Inc ( Site 0108)
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QuébecCanadaUnknown status
Care Access - Thunder Bay ( Site 0130)
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Thunder BayCanadaUnknown status
EBA Centelles ( Site 0600)
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BarcelonaSpainUnknown status
EAP Sardenya ( Site 0601)
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BarcelonaSpainUnknown status
Centro de Salud Concepcion Arenal ( Site 0603)
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Santiago de CompostelaSpainUnknown status
Velocity Clinical Research Romford ( Site 0803)
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BristolUnited KingdomUnknown status
Lakeside Surgery ( Site 0802)
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CorbyUnited KingdomUnknown status
William Harvey Heart Centre ( Site 0800)
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LondonUnited KingdomUnknown status
Velocity Clinical Research Havering ( Site 0804)
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LondonUnited KingdomUnknown status
West Walk Surgery ( Site 0801)
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YateUnited KingdomUnknown status
Lausmed Egészségügyi Szolgáltató ( Site 1105)
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BajaHungaryUnknown status
DRC Gyógyszervizsgáló Központ ( Site 1109)
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BalatonfüredHungaryUnknown status
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102)
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DebrecenHungaryUnknown status
Borbánya Praxis ( Site 1103)
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NyíregyházaHungaryUnknown status
Barzilai Medical Center ( Site 0504)
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AshkelonIsraelUnknown status
Linn Medical Center ( Site 0503)
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HaifaIsraelUnknown status
Rambam Health Care Campus ( Site 0500)
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HaifaIsraelUnknown status
Meir Medical Center. ( Site 0501)
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Kfar SabaIsraelUnknown status
Clalit Health Services - Sakhnin Community Clinic ( Site 0502)
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SakhninIsraelUnknown status
Pacific Clinical Research Network - Forte ( Site 1004)
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ChristchurchNew ZealandUnknown status
Lakeland Clinical Trials Waikato ( Site 1000)
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NawtonNew ZealandUnknown status
Pacific Clinical Research Network - Tasman ( Site 1003)
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NelsonNew ZealandUnknown status
Pacific Clinical Research Network - Rotorua ( Site 1001)
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RotoruaNew ZealandUnknown status
Lakeland Clinical Trials Wellington ( Site 1002)
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Upper HuttNew ZealandUnknown status
New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)
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AlbuquerqueUnited StatesUnknown status
Conquest Research ( Site 0045)
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ArlingtonUnited StatesUnknown status
Central Research Associates ( Site 0009)
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BirminghamUnited StatesUnknown status
Trialmed ( Site 0026)
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ChicagoUnited StatesUnknown status
Great Lakes Clinical Trials - Ravenswood ( Site 0018)
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ChicagoUnited StatesUnknown status
Legacy Clinical Trials ( Site 0044)
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Colorado SpringsUnited StatesUnknown status
Cardiovascular Associates of the Delaware Valley ( Site 0035)
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ElmerUnited StatesUnknown status
G&L Research ( Site 0024)
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FoleyUnited StatesUnknown status
Alliance for Multispecialty Research, LLC ( Site 0040)
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Fort MyersUnited StatesUnknown status
Soffer Health Institute ( Site 0046)
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HollywoodUnited StatesUnknown status
Provecta Research Network LLC ( Site 0022)
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HoustonUnited StatesUnknown status
Midwest Institute For Clinical Research ( Site 0033)
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IndianapolisUnited StatesUnknown status
East Coast Institute for Research ( Site 0041)
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Lake CityUnited StatesUnknown status
Chemidox Clinical Trials ( Site 0008)
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LancasterUnited StatesUnknown status
Jubilee Clinical Research ( Site 0031)
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Las VegasUnited StatesUnknown status
L-MARC Research Center ( Site 0004)
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LouisvilleUnited StatesUnknown status
Manassas Clinical Research Center ( Site 0002)
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ManassasUnited StatesUnknown status
Inpatient Research Clinic ( Site 0017)
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Miami LakesUnited StatesUnknown status
Health Research of Hampton Roads, Inc. ( Site 0013)
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Newport NewsUnited StatesUnknown status
Alliance for Multispecialty Research, LLC ( Site 0048)
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NewtonUnited StatesUnknown status
Alliance for Multispecialty Research, LLC - Norman ( Site 0043)
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NormanUnited StatesUnknown status
Permian Research Foundation ( Site 0005)
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OdessaUnited StatesUnknown status
LinQ Research ( Site 0025)
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PearlandUnited StatesUnknown status
Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
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PhoenixUnited StatesUnknown status
Rainier Clinical Research ( Site 0023)
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RentonUnited StatesUnknown status
National Clinical Research, Inc ( Site 0028)
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RichmondUnited StatesUnknown status
Clinical Trials Research ( Site 0036)
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SacramentoUnited StatesUnknown status
Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)
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San AntonioUnited StatesUnknown status
Clinical Trials of Texas, Inc. ( Site 0010)
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San AntonioUnited StatesUnknown status
Clinical Research Trials of Florida ( Site 0001)
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TampaUnited StatesUnknown status
Alliance for Multispecialty Research LLC ( Site 0049)
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TempeUnited StatesUnknown status
LinQ Research - Tomball ( Site 0047)
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TomballUnited StatesUnknown status
Cotton O'Neil Clinical Research Center ( Site 0006)
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TopekaUnited StatesUnknown status
Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)
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Winter ParkUnited StatesUnknown status
Cardiology Consultants of Philadelphia Yardley ( Site 0016)
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YardleyUnited StatesUnknown status
Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)
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AnkaraTurkey (Türkiye)Unknown status
Eskisehir Osmangazi University ( Site 0705)
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EskişehirTurkey (Türkiye)Unknown status
Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)
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IstanbulTurkey (Türkiye)Unknown status
Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)
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KayseriTurkey (Türkiye)Unknown status
İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)
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MalatyaTurkey (Türkiye)Unknown status
Hacettepe Universite Hastaneleri ( Site 0700)
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SıhhiyeTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.