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, Alabama 35205
Contact:
Study Coordinator
205-327-1077

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Rainier Clinical Research ( Site 0023)
Renton, Washington 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