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
Status: Recruiting
Location: See all (89) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:
• Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.
Locations
United States
Alabama
Central Research Associates ( Site 0009)
ACTIVE_NOT_RECRUITING
Birmingham
G&L Research ( Site 0024)
ACTIVE_NOT_RECRUITING
Foley
Arizona
Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
ACTIVE_NOT_RECRUITING
Phoenix
Alliance for Multispecialty Research LLC ( Site 0049)
ACTIVE_NOT_RECRUITING
Tempe
California
Chemidox Clinical Trials ( Site 0008)
ACTIVE_NOT_RECRUITING
Lancaster
Clinical Trials Research ( Site 0036)
ACTIVE_NOT_RECRUITING
Sacramento
Colorado
Legacy Clinical Trials ( Site 0044)
ACTIVE_NOT_RECRUITING
Colorado Springs
Florida
Alliance for Multispecialty Research, LLC ( Site 0040)
ACTIVE_NOT_RECRUITING
Fort Myers
Soffer Health Institute ( Site 0046)
ACTIVE_NOT_RECRUITING
Hollywood
East Coast Institute for Research ( Site 0041)
ACTIVE_NOT_RECRUITING
Lake City
Inpatient Research Clinic ( Site 0017)
ACTIVE_NOT_RECRUITING
Miami Lakes
Clinical Research Trials of Florida ( Site 0001)
ACTIVE_NOT_RECRUITING
Tampa
Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)
ACTIVE_NOT_RECRUITING
Winter Park
Illinois
Great Lakes Clinical Trials - Ravenswood ( Site 0018)
ACTIVE_NOT_RECRUITING
Chicago
Trialmed ( Site 0026)
ACTIVE_NOT_RECRUITING
Chicago
Indiana
Midwest Institute For Clinical Research ( Site 0033)
ACTIVE_NOT_RECRUITING
Indianapolis
Kansas
Alliance for Multispecialty Research, LLC ( Site 0048)
ACTIVE_NOT_RECRUITING
Newton
Cotton O'Neil Clinical Research Center ( Site 0006)
ACTIVE_NOT_RECRUITING
Topeka
Kentucky
Monroe Biomedical Research ( Site 0004)
ACTIVE_NOT_RECRUITING
Louisville
New Jersey
Cardiovascular Associates of the Delaware Valley ( Site 0035)
ACTIVE_NOT_RECRUITING
Elmer
New Mexico
New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)
ACTIVE_NOT_RECRUITING
Albuquerque
Nevada
Jubilee Clinical Research ( Site 0031)
ACTIVE_NOT_RECRUITING
Las Vegas
Oklahoma
Alliance for Multispecialty Research, LLC - Norman ( Site 0043)
ACTIVE_NOT_RECRUITING
Norman
Pennsylvania
Cardiology Consultants of Philadelphia Yardley ( Site 0016)
ACTIVE_NOT_RECRUITING
Yardley
Texas
Provecta Research Network LLC ( Site 0022)
RECRUITING
Houston
Permian Research Foundation ( Site 0005)
ACTIVE_NOT_RECRUITING
Odessa
LinQ Research ( Site 0025)
ACTIVE_NOT_RECRUITING
Pearland
Clinical Trials of Texas, Inc. ( Site 0010)
RECRUITING
San Antonio
Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)
ACTIVE_NOT_RECRUITING
San Antonio
LinQ Research - Tomball ( Site 0047)
ACTIVE_NOT_RECRUITING
Tomball
Virginia
Manassas Clinical Research Center ( Site 0002)
ACTIVE_NOT_RECRUITING
Manassas
Health Research of Hampton Roads, Inc. ( Site 0013)
ACTIVE_NOT_RECRUITING
Newport News
National Clinical Research, Inc ( Site 0028)
ACTIVE_NOT_RECRUITING
Richmond
Conquest Research ( Site 0045)
ACTIVE_NOT_RECRUITING
Vienna
Washington
Rainier Clinical Research ( Site 0023)
ACTIVE_NOT_RECRUITING
Renton
Other Locations
Argentina
CIPREC-CIPREC Sede Arenales ( Site 0200)
ACTIVE_NOT_RECRUITING
Buenos Aires
CEMEDIC ( Site 0201)
ACTIVE_NOT_RECRUITING
Caba
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206)
ACTIVE_NOT_RECRUITING
Caba
Instituto de Cardiología Juana F. Cabral-Cardiología ( Site 0205)
ACTIVE_NOT_RECRUITING
Corrientes
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)
ACTIVE_NOT_RECRUITING
Mar Del Plata
Fundacion Estudios Clinicos ( Site 0203)
ACTIVE_NOT_RECRUITING
Rosario
Instituto de Investigaciones Clinicas Rosario ( Site 0204)
ACTIVE_NOT_RECRUITING
Rosario
Australia
Emeritus Research ( Site 0904)
ACTIVE_NOT_RECRUITING
Camberwell
Baker - HeartWest ( Site 0902)
ACTIVE_NOT_RECRUITING
Hoppers Crossing
Australian Clinical Research Network ( Site 0900)
ACTIVE_NOT_RECRUITING
Maroubra
Fusion Clinical Research ( Site 0901)
ACTIVE_NOT_RECRUITING
Norwood
Momentum Darlinghurst ( Site 0906)
ACTIVE_NOT_RECRUITING
Sydney
Momentum Clinical Research Taringa ( Site 0907)
ACTIVE_NOT_RECRUITING
Taringa
Brazil
Centro de Pesquisa Clinica do Coracao ( Site 0303)
RECRUITING
Aracaju
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305)
ACTIVE_NOT_RECRUITING
Bragança Paulista
Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306)
RECRUITING
Fortaleza
IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)
RECRUITING
Rio De Janeiro
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309)
RECRUITING
São José Do Rio Preto
Canada
Milestone Research Inc. ( Site 0111)
ACTIVE_NOT_RECRUITING
London
Centricity Research Mirabel Multispecialty ( Site 0107)
ACTIVE_NOT_RECRUITING
Mirabel
G A Research Associates ( Site 0102)
ACTIVE_NOT_RECRUITING
Moncton
Institut de Cardiologie de Montreal ( Site 0109)
RECRUITING
Montreal
North York Diagnostic and Cardiac Centre ( Site 0110)
RECRUITING
North York
Recherche Clinique Sigma Inc ( Site 0108)
ACTIVE_NOT_RECRUITING
Québec
Care Access - Thunder Bay ( Site 0130)
RECRUITING
Thunder Bay
Hungary
Lausmed Egészségügyi Szolgáltató ( Site 1105)
ACTIVE_NOT_RECRUITING
Baja
DRC Gyógyszervizsgáló Központ ( Site 1109)
ACTIVE_NOT_RECRUITING
Balatonfüred
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102)
ACTIVE_NOT_RECRUITING
Debrecen
Borbánya Praxis ( Site 1103)
ACTIVE_NOT_RECRUITING
Nyíregyháza
Israel
Barzilai Medical Center ( Site 0504)
ACTIVE_NOT_RECRUITING
Ashkelon
Linn Medical Center ( Site 0503)
ACTIVE_NOT_RECRUITING
Haifa
Rambam Health Care Campus ( Site 0500)
ACTIVE_NOT_RECRUITING
Haifa
Meir Medical Center. ( Site 0501)
ACTIVE_NOT_RECRUITING
Kfar Saba
Clalit Health Services - Sakhnin Community Clinic ( Site 0502)
ACTIVE_NOT_RECRUITING
Sakhnin
New Zealand
Pacific Clinical Research Network - Forte ( Site 1004)
ACTIVE_NOT_RECRUITING
Christchurch
Lakeland Clinical Trials Waikato ( Site 1000)
ACTIVE_NOT_RECRUITING
Nawton
Pacific Clinical Research Network - Tasman ( Site 1003)
ACTIVE_NOT_RECRUITING
Nelson
Pacific Clinical Research Network - Rotorua ( Site 1001)
ACTIVE_NOT_RECRUITING
Rotorua
Lakeland Clinical Trials Wellington ( Site 1002)
ACTIVE_NOT_RECRUITING
Upper Hutt
Spain
EAP Sardenya ( Site 0601)
ACTIVE_NOT_RECRUITING
Barcelona
EBA Centelles ( Site 0600)
ACTIVE_NOT_RECRUITING
Barcelona
Centro de Salud Concepcion Arenal ( Site 0603)
ACTIVE_NOT_RECRUITING
Santiago De Compostela
Turkey
Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)
ACTIVE_NOT_RECRUITING
Ankara
Eskisehir Osmangazi University ( Site 0705)
ACTIVE_NOT_RECRUITING
Eskişehir
Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)
ACTIVE_NOT_RECRUITING
Istanbul
Ege Universitesi Hastanesi ( Site 0708)
ACTIVE_NOT_RECRUITING
Izmir
Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)
ACTIVE_NOT_RECRUITING
Kayseri
İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)
ACTIVE_NOT_RECRUITING
Malatya
Hacettepe Universite Hastaneleri ( Site 0700)
ACTIVE_NOT_RECRUITING
Sıhhiye
United Kingdom
Velocity Clinical Research, Bristol ( Site 0803)
ACTIVE_NOT_RECRUITING
Bristol
Lakeside Surgery ( Site 0802)
ACTIVE_NOT_RECRUITING
Corby
Velocity Clinical Research Havering ( Site 0804)
ACTIVE_NOT_RECRUITING
London
William Harvey Heart Centre ( Site 0800)
ACTIVE_NOT_RECRUITING
London
West Walk Surgery ( Site 0801)
ACTIVE_NOT_RECRUITING
Yate
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 975
Treatments
Experimental: Enlicitide
Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
Experimental: Enlicitide + Rosuvastatin
Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
Active_comparator: Rosuvastatin
Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
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.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC