A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)

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

  • Lipoprotein(a)

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

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

Clinical Trials Research ( 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

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

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

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

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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