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

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

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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