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

NCT07614984

RecruitingPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Lipoprotein(a)

Interventions: MK-7262, Enlicitide, Placebo for MK-7262, Placebo for enlicitide

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (12)
  • Alexander City, Alabama, United States
  • Mobile, Alabama, United States
  • Beverly Hills, California, United States
  • Lincoln, California, United States
  • Waterbury, Connecticut, United States
  • Miami Lakes, Florida, United States
  • Tampa, Florida, United States
  • Winter Park, Florida, United States
  • Albuquerque, New Mexico, United States
  • Columbus, Ohio, United States
  • Kingsport, Tennessee, United States
  • Manassas, Virginia, United States