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A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)

RecruitingPhase 3Ages 18 Years - anyAllMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

Researchers are looking for new ways to treat high cholesterol. Cholesterol is a type of fat in the blood. Enlicitide (also known as enlicitide decanoate or MK-0616), the study medicine, is in a class of medicines designed to lower low-density lipoprotein cholesterol (LDL-C). LDL-C is sometimes called "bad cholesterol." The goal of this study is to learn if enlicitide works better than placebo to lower the amount of LDL-C in a person's blood. Researchers also want to learn about the safety of enlicitide and if people tolerate it.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * History of a major atherosclerotic cardiovascular disease (ASCVD) event or if no history of a major ASCVD event, has one or more of the following: possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH), diabetes mellitus, stable angina pectoris, transient ischemic attack or symptomatic peripheral arterial disease * Has a low-density lipoprotein cholesterol (LDL-C) ≥55 mg/dL or ≥70 mg/dL depending on medical history * Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance * If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Had a heart failure hospitalization within 3 months before Screening * Has unstable angina, a myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening * Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program * Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors * Has a history of nephrotic syndrome * Has poorly controlled diabetes mellitus * Has hyperthyroidism or inadequately controlled hypothyroidism * Is actively receiving chemotherapy for malignancy or has a history of malignancy ≤3 years before Screening
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What it tests

  • Enlicitide Decanoate
  • Placebo
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Where

1 site
KLES Prabhakar Kore Hospital & Medical Research Centre [M] ( Site 1004)
Belagavi, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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