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NCT07614984
A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)
Conditions: Lipoprotein(a)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 750
Sponsor: Merck Sharp & Dohme LLC
Location: Advanced Cardiovascular - Alexander City ( Site 0158) Alexander City Alabama
Summary
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 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
Source: ClinicalTrials.gov (NCT07614984). StuddyBuddy aggregates publicly available trial information.