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 (44) 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)
RECRUITING
Birmingham
G&L Research ( Site 0024)
RECRUITING
Foley
Arizona
Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
RECRUITING
Phoenix
Alliance for Multispecialty Research LLC ( Site 0049)
RECRUITING
Tempe
California
Chemidox Clinical Trials ( Site 0008)
RECRUITING
Lancaster
Clinical Trials Research ( Site 0036)
RECRUITING
Sacramento
Colorado
Legacy Clinical Trials ( Site 0044)
RECRUITING
Colorado Springs
Florida
Alliance for Multispecialty Research, LLC ( Site 0040)
RECRUITING
Fort Myers
Soffer Health Institute ( Site 0046)
RECRUITING
Hollywood
East Coast Institute for Research ( Site 0041)
RECRUITING
Lake City
Inpatient Research Clinic ( Site 0017)
RECRUITING
Miami Lakes
Clinical Research Trials of Florida ( Site 0001)
RECRUITING
Tampa
Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)
RECRUITING
Winter Park
Illinois
Great Lakes Clinical Trials - Ravenswood ( Site 0018)
RECRUITING
Chicago
Trialmed ( Site 0026)
RECRUITING
Chicago
Indiana
Midwest Institute For Clinical Research ( Site 0033)
RECRUITING
Indianapolis
Kansas
Alliance for Multispecialty Research, LLC ( Site 0048)
RECRUITING
Newton
Cotton O'Neil Clinical Research Center ( Site 0006)
RECRUITING
Topeka
Kentucky
L-MARC Research Center ( Site 0004)
RECRUITING
Louisville
New Jersey
Cardiovascular Associates of the Delaware Valley ( Site 0035)
RECRUITING
Elmer
New Mexico
New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)
RECRUITING
Albuquerque
Nevada
Jubilee Clinical Research ( Site 0031)
RECRUITING
Las Vegas
Oklahoma
Alliance for Multispecialty Research, LLC - Norman ( Site 0043)
RECRUITING
Norman
Pennsylvania
Cardiology Consultants of Philadelphia Yardley ( Site 0016)
RECRUITING
Yardley
Texas
Provecta Research Network LLC ( Site 0022)
RECRUITING
Houston
Permian Research Foundation ( Site 0005)
RECRUITING
Odessa
LinQ Research ( Site 0025)
RECRUITING
Pearland
Clinical Trials of Texas, Inc. ( Site 0010)
RECRUITING
San Antonio
Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)
RECRUITING
San Antonio
LinQ Research - Tomball ( Site 0047)
RECRUITING
Tomball
Virginia
Conquest Research ( Site 0045)
RECRUITING
Arlington
Manassas Clinical Research Center ( Site 0002)
RECRUITING
Manassas
Health Research of Hampton Roads, Inc. ( Site 0013)
RECRUITING
Newport News
National Clinical Research, Inc ( Site 0028)
RECRUITING
Richmond
Washington
Rainier Clinical Research ( Site 0023)
RECRUITING
Renton
Other Locations
Australia
Emeritus Research ( Site 0904)
RECRUITING
Camberwell
Australian Clinical Research Network ( Site 0900)
RECRUITING
Maroubra
Fusion Clinical Research ( Site 0901)
RECRUITING
Norwood
Momentum Darlinghurst ( Site 0906)
RECRUITING
Sydney
Momentum Wellers Hill ( Site 0907)
RECRUITING
Tarragindi
Israel
Rambam Health Care Campus ( Site 0500)
RECRUITING
Haifa
United Kingdom
Velocity Clinical Research Romford ( Site 0803)
RECRUITING
Bristol
Lakeside Surgery ( Site 0802)
RECRUITING
Corby
Velocity Clinical Research Havering ( Site 0804)
RECRUITING
London
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