Print

Purpose

Researchers designed a trial medicine called MK-7262 to lower levels of Lp(a) in the blood. Researchers want to learn about giving MK-7262 with another trial medicine called enlicitide (also known as MK-0616 or enlicitide decanoate). Enlicitide is in a group of medicines that lower the amount of low-density lipoprotein cholesterol (LDL-C). The goals of this trial are to evaluate: - if MK-7262 and enlicitide taken together work better than placebo at lowering Lp(a) and LDL-C levels in the blood - if MK-7262 alone works better than placebo at lowering Lp(a) levels in the blood - the safety and tolerability of taking MK-7262 and enlicitide alone and together

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

The main inclusion criteria include but are not limited to the following: - Has Lp(a) ≥ 150 nmol/L - Is receiving an optimized and stable dose of statin for ≥ 30 days with no planned additions, dose changes, or discontinuations through the duration of the study

Exclusion Criteria

The main exclusion criteria include but are not limited to the following: - Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH - Has a history of class IV heart failure, severe ventricular systolic dysfunction, uncontrolled ventricular arrhythmia, markedly prolonged corrected QT interval, untreated hypertension, or a recent coronary, cerebrovascular, or peripheral ischemic event or arterial revascularization - Has human immunodeficiency virus infection, unless the infection is controlled (i.e. undetectable viral load) - Has an active hepatitis C virus infection or active or chronic hepatitis B virus infection - Has a history of nephrotic syndrome - Has severe renal insufficiency - Has received certain therapies in the prohibited timeframe as specified in the protocol - Has active or chronic hepatobiliary or hepatic disease - Has poorly controlled Type 1 or Type 2 diabetes

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
  • Drug: Placebo for MK-7262
    Oral Coated Tablet
  • Drug: Placebo for enlicitide
    Oral Coated Tablet
Active Comparator
enlicitide monotherapy 		Participants will receive enlicitide + MK-7262 placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
  • Drug: Enlicitide
    Oral Coated Tablet
    Other names:
    • MK-0616
    • enlicitide decanoate
  • Drug: Placebo for MK-7262
    Oral Coated Tablet
Experimental
MK-7262 monotherapy 		Participants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
  • Drug: MK-7262
    Oral Coated Tablet
    Other names:
    • HRS-5346
  • Drug: Placebo for enlicitide
    Oral Coated Tablet
Experimental
MK-7262 + enlicitide 		Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment.
  • Drug: MK-7262
    Oral Coated Tablet
    Other names:
    • HRS-5346
  • Drug: Enlicitide
    Oral Coated Tablet
    Other names:
    • MK-0616
    • enlicitide decanoate

Recruiting Locations

Advanced Cardiovascular - Alexander City ( Site 0158)
Alexander City, Alabama 35010
Contact:
Study Coordinator
256-215-5323

AMR Clinical Mobile ( Site 0149)
Mobile, Alabama 36608
Contact:
Study Coordinator
251-414-1984

National Heart Institute ( Site 0113)
Beverly Hills, California 90211-2285
Contact:
Study Coordinator
310-289-5221

Headlands Research CTR Lincoln ( Site 0127)
Lincoln, California 95648
Contact:
Study Coordinator
916-434-8230

Chase Medical Research, LLC ( Site 0163)
Waterbury, Connecticut 06708
Contact:
Study Coordinator
203-419-4420

Soffer Health Institute ( Site 0123)
Hollywood, Florida 33020
Contact:
Study Coordinator
305-250-2106

Westside Center for Clinical Research ( Site 0161)
Jacksonville, Florida 32205
Contact:
Study Coordinator
904-693-1490

Inpatient Research Clinic ( Site 0110)
Miami Lakes, Florida 33014
Contact:
Study Coordinator
786-502-4303

Clinical Research Trials of Florida ( Site 0101)
Tampa, Florida 33607
Contact:
Study Coordinator
813-873-8102

Conquest Research LLC ( Site 0140)
Winter Park, Florida 32789
Contact:
Study Coordinator
407-916-0060

Flourish Research - Bowie ( Site 0106)
Bowie, Maryland 20715
Contact:
Study Coordinator
410-824-1341

Velocity Clinical Research Rockville ( Site 0146)
Rockville, Maryland 20854
Contact:
Study Coordinator
240-698-2800

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0132)
Troy, Michigan 48098
Contact:
Study Coordinator
248-312-0025

Minneapolis Heart Institute - Minneapolis ( Site 0130)
Minneapolis, Minnesota 55407
Contact:
Study Coordinator
612-863-3833

Montana Medical Research, Inc. ( Site 0156)
Missoula, Montana 59808
Contact:
Study Coordinator
406-549-1124

New Mexico Clinical Research & Osteoporosis Center ( Site 0119)
Albuquerque, New Mexico 87106
Contact:
Study Coordinator
505-855-5505

Laurelton Heart Specialist PC ( Site 0155)
Rosedale, New York 11422
Contact:
Study Coordinator
718-949-9400

Velocity Clinical Research, Durham ( Site 0145)
Durham, North Carolina 27701
Contact:
Study Coordinator
919-503-4711

Remington-Davis, Inc. ( Site 0107)
Columbus, Ohio 43215
Contact:
Study Coordinator
614-487-2560

Holston Medical Group ( Site 0117)
Kingsport, Tennessee 37660
Contact:
Study Coordinator
423-857-2789

Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0154)
Houston, Texas 77030
Contact:
Study Coordinator
713-798-5800

DM Clinical Research ( Site 0115)
Tomball, Texas 77375
Contact:
Study Coordinator
346-550-9559

Carient Heart & Vascular - Manassas ( Site 0165)
Manassas, Virginia 20109
Contact:
Study Coordinator
571-581-1771

Rainier Clinical Research Center ( Site 0116)
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@merck.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.