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

Purpose

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.

Condition

  • Hyperlipidemia

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH. - Had a heart failure hospitalization within 3 months before Screening. - 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. - 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Enlicitide 		Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
  • Drug: Enlicitide
    Oral Tablet
    Other names:
    • MK-0616
    • Enlicitide decanoate
  • Drug: Placebo for Rosuvastatin
    Oral Capsule
Experimental
Enlicitide + Rosuvastatin 		Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
  • Drug: Enlicitide
    Oral Tablet
    Other names:
    • MK-0616
    • Enlicitide decanoate
  • Drug: Rosuvastatin
    Oral Capsule
Active Comparator
Rosuvastatin 		Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
  • Drug: Rosuvastatin
    Oral Capsule
  • Drug: Placebo for Enlicitide
    Oral Tablet
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.
  • Drug: Placebo for Enlicitide
    Oral Tablet
  • Drug: Placebo for Rosuvastatin
    Oral Capsule

Recruiting Locations

Central Research Associates ( Site 0009)
Birmingham 4049979, Alabama 4829764 35205
Contact:
Study Coordinator
205-327-1077

G&L Research ( Site 0024)
Foley 4062644, Alabama 4829764 36535
Contact:
Study Coordinator
251-943-2980

Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
Phoenix 5308655, Arizona 5551752 85020
Contact:
Study Coordinator
602-200-3814

Alliance for Multispecialty Research LLC ( Site 0049)
Tempe 5317058, Arizona 5551752 85281
Contact:
Study Coordinator
602-910-3343

Chemidox Clinical Trials ( Site 0008)
Lancaster 5364940, California 5332921 93534
Contact:
Study Coordinator
833-324-3643

Clinical Trials Research ( Site 0036)
Sacramento 5389489, California 5332921 95821
Contact:
Study Coordinator
916-487-8230

Legacy Clinical Trials ( Site 0044)
Colorado Springs 5417598, Colorado 5417618 80909
Contact:
Study Coordinator
719-387-7572

Alliance for Multispecialty Research, LLC ( Site 0040)
Fort Myers 4155995, Florida 4155751 33912
Contact:
Study Coordinator
239-936-4421

Soffer Health Institute ( Site 0046)
Hollywood 4158928, Florida 4155751 33020
Contact:
Study Coordinator
305-792-0555

East Coast Institute for Research ( Site 0041)
Lake City 4161187, Florida 4155751 32055
Contact:
Study Coordinator
386-463-5356

Inpatient Research Clinic ( Site 0017)
Miami Lakes 4164186, Florida 4155751 33014
Contact:
Study Coordinator
786-502-4303

Clinical Research Trials of Florida ( Site 0001)
Tampa 4174757, Florida 4155751 33607
Contact:
Study Coordinator
813-873-8102

Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)
Winter Park 4178560, Florida 4155751 32789
Contact:
Study Coordinator
407-740-8078

Trialmed ( Site 0026)
Chicago 4887398, Illinois 4896861 60602
Contact:
Study Coordinator
877-469-4154

Great Lakes Clinical Trials - Ravenswood ( Site 0018)
Chicago 4887398, Illinois 4896861 60640
Contact:
Study Coordinator
773-275-3500

Midwest Institute For Clinical Research ( Site 0033)
Indianapolis 4259418, Indiana 4921868 46260-5310
Contact:
Study Coordinator
317-705-7050

Alliance for Multispecialty Research, LLC ( Site 0048)
Newton 4276248, Kansas 4273857 67114
Contact:
Study Coordinator
316-804-7301

Cotton O'Neil Clinical Research Center ( Site 0006)
Topeka 4280539, Kansas 4273857 66606
Contact:
Study Coordinator
785-368-0744

L-MARC Research Center ( Site 0004)
Louisville 4299276, Kentucky 6254925 40213
Contact:
Study Coordinator
502-515-5672

Jubilee Clinical Research ( Site 0031)
Las Vegas 5506956, Nevada 5509151 89106
Contact:
Study Coordinator
702-631-5000

Cardiovascular Associates of the Delaware Valley ( Site 0035)
Elmer 4501678, New Jersey 5101760 08318
Contact:
Study Coordinator
856-358-8125

New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)
Albuquerque 5454711, New Mexico 5481136 87106-4725
Contact:
Study Coordinator
505-855-5505

Alliance for Multispecialty Research, LLC - Norman ( Site 0043)
Norman 4543762, Oklahoma 4544379 73069
Contact:
Study Coordinator
405-701-8999

Cardiology Consultants of Philadelphia Yardley ( Site 0016)
Yardley 5220281, Pennsylvania 6254927 19067
Contact:
Study Coordinator
215-321-7400

Provecta Research Network LLC ( Site 0022)
Houston 4699066, Texas 4736286 77027
Contact:
Study Coordinator
346-735-8990

Permian Research Foundation ( Site 0005)
Odessa 5527554, Texas 4736286 79761
Contact:
Study Coordinator
432-368-6950

LinQ Research ( Site 0025)
Pearland 4718097, Texas 4736286 77584
Contact:
Study Coordinator
281-916-4220

Clinical Trials of Texas, Inc. ( Site 0010)
San Antonio 4726206, Texas 4736286 78229
Contact:
Study Coordinator
210-949-0122

Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)
San Antonio 4726206, Texas 4736286 78258
Contact:
Study Coordinator
210-591-1154

LinQ Research - Tomball ( Site 0047)
Tomball 4737094, Texas 4736286 77375
Contact:
Study Coordinator
281-351-6250

Conquest Research ( Site 0045)
Arlington 4744709, Virginia 6254928 22205
Contact:
Study Coordinator
703-936-0761

Manassas Clinical Research Center ( Site 0002)
Manassas 4771401, Virginia 6254928 20110
Contact:
Study Coordinator
703-330-1112

Health Research of Hampton Roads, Inc. ( Site 0013)
Newport News 4776024, Virginia 6254928 23606
Contact:
Study Coordinator
757-591-8100

National Clinical Research, Inc ( Site 0028)
Richmond 4781708, Virginia 6254928 23294
Contact:
Study Coordinator
804-755-2300

Rainier Clinical Research ( Site 0023)
Renton 5808189, Washington 5815135 98057
Contact:
Study Coordinator
425-251-1720

More Details

NCT ID
NCT07216482
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center