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: Active_not_recruiting
Location: See all (87) 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)
Birmingham
G&L Research ( Site 0024)
Foley
Arizona
Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
Phoenix
Alliance for Multispecialty Research LLC ( Site 0049)
Tempe
California
Chemidox Clinical Trials ( Site 0008)
Lancaster
Clinical Trials Research ( Site 0036)
Sacramento
Colorado
Legacy Clinical Trials ( Site 0044)
Colorado Springs
Florida
Alliance for Multispecialty Research, LLC ( Site 0040)
Fort Myers
Soffer Health Institute ( Site 0046)
Hollywood
East Coast Institute for Research ( Site 0041)
Lake City
Inpatient Research Clinic ( Site 0017)
Miami Lakes
Clinical Research Trials of Florida ( Site 0001)
Tampa
Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)
Winter Park
Illinois
Great Lakes Clinical Trials - Ravenswood ( Site 0018)
Chicago
Trialmed ( Site 0026)
Chicago
Indiana
Midwest Institute For Clinical Research ( Site 0033)
Indianapolis
Kansas
Alliance for Multispecialty Research, LLC ( Site 0048)
Newton
Cotton O'Neil Clinical Research Center ( Site 0006)
Topeka
Kentucky
L-MARC Research Center ( Site 0004)
Louisville
New Jersey
Cardiovascular Associates of the Delaware Valley ( Site 0035)
Elmer
New Mexico
New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)
Albuquerque
Nevada
Jubilee Clinical Research ( Site 0031)
Las Vegas
Oklahoma
Alliance for Multispecialty Research, LLC - Norman ( Site 0043)
Norman
Pennsylvania
Cardiology Consultants of Philadelphia Yardley ( Site 0016)
Yardley
Texas
Provecta Research Network LLC ( Site 0022)
Houston
Permian Research Foundation ( Site 0005)
Odessa
LinQ Research ( Site 0025)
Pearland
Clinical Trials of Texas, Inc. ( Site 0010)
San Antonio
Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)
San Antonio
LinQ Research - Tomball ( Site 0047)
Tomball
Virginia
Conquest Research ( Site 0045)
Arlington
Manassas Clinical Research Center ( Site 0002)
Manassas
Health Research of Hampton Roads, Inc. ( Site 0013)
Newport News
National Clinical Research, Inc ( Site 0028)
Richmond
Washington
Rainier Clinical Research ( Site 0023)
Renton
Other Locations
Argentina
CIPREC-CIPREC Sede Arenales ( Site 0200)
Buenos Aires
CEMEDIC ( Site 0201)
Caba
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206)
Caba
Instituto de Cardiología Juana F. Cabral-Cardiología ( Site 0205)
Corrientes
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)
Mar Del Plata
Fundacion Estudios Clinicos ( Site 0203)
Rosario
Instituto de Investigaciones Clinicas Rosario ( Site 0204)
Rosario
Australia
Emeritus Research ( Site 0904)
Camberwell
Baker - HeartWest ( Site 0902)
Hoppers Crossing
Australian Clinical Research Network ( Site 0900)
Maroubra
Fusion Clinical Research ( Site 0901)
Norwood
Momentum Darlinghurst ( Site 0906)
Sydney
Momentum Clinical Research Taringa ( Site 0907)
Taringa
Brazil
Centro de Pesquisa Clinica do Coracao ( Site 0303)
Aracaju
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305)
Bragança Paulista
Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306)
Fortaleza
IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)
Rio De Janeiro
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309)
São José Do Rio Preto
Canada
Milestone Research Inc. ( Site 0111)
London
Centricity Research Mirabel Multispecialty ( Site 0107)
Mirabel
G A Research Associates ( Site 0102)
Moncton
North York Diagnostic and Cardiac Centre ( Site 0110)
North York
Recherche Clinique Sigma Inc ( Site 0108)
Québec
Care Access - Thunder Bay ( Site 0130)
Thunder Bay
Hungary
Lausmed Egészségügyi Szolgáltató ( Site 1105)
Baja
DRC Gyógyszervizsgáló Központ ( Site 1109)
Balatonfüred
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102)
Debrecen
Borbánya Praxis ( Site 1103)
Nyíregyháza
Israel
Barzilai Medical Center ( Site 0504)
Ashkelon
Linn Medical Center ( Site 0503)
Haifa
Rambam Health Care Campus ( Site 0500)
Haifa
Meir Medical Center. ( Site 0501)
Kfar Saba
Clalit Health Services - Sakhnin Community Clinic ( Site 0502)
Sakhnin
New Zealand
Pacific Clinical Research Network - Forte ( Site 1004)
Christchurch
Lakeland Clinical Trials Waikato ( Site 1000)
Nawton
Pacific Clinical Research Network - Tasman ( Site 1003)
Nelson
Pacific Clinical Research Network - Rotorua ( Site 1001)
Rotorua
Lakeland Clinical Trials Wellington ( Site 1002)
Upper Hutt
Spain
EAP Sardenya ( Site 0601)
Barcelona
EBA Centelles ( Site 0600)
Barcelona
Centro de Salud Concepcion Arenal ( Site 0603)
Santiago De Compostela
Turkey
Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)
Ankara
Eskisehir Osmangazi University ( Site 0705)
Eskişehir
Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)
Istanbul
Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)
Kayseri
İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)
Malatya
Hacettepe Universite Hastaneleri ( Site 0700)
Sıhhiye
United Kingdom
Velocity Clinical Research Romford ( Site 0803)
Bristol
Lakeside Surgery ( Site 0802)
Corby
Velocity Clinical Research Havering ( Site 0804)
London
William Harvey Heart Centre ( Site 0800)
London
West Walk Surgery ( Site 0801)
Yate
Time Frame
Start Date: 2025-11-11
Completion Date: 2026-11-05
Participants
Target number of participants: 996
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