Purpose:
To determine the ability of MK-0616, an oral PCSK9 blocking drug that lowers LDL-cholesterol in patients with known or at high risk of coronary vascular disease, to prevent major cardiovascular events on top of the use of approved cholesterol-lowering agents.
Description:
Cardiovascular disease, principally atherosclerotic coronary vascular disease, ASCVD, including heart attack, stroke and peripheral artery disease, is the leading cause of global mortality and a major contributor to disability. Epidemiologic, genetic, and clinical intervention studies have shown that LDL-cholesterol is causally associated with ASCVD, and that lifestyle modifications such as diet and exercise and medications that lower LDL-C lowers the risk of heart attack, stroke, and death from cardiovascular disease. Despite currently available therapies, including statins, 50% of patients do not reach LDL-C treatment goals for a variety of reasons, including non-compliance due to side effects such as muscle achiness. A new class of medications that inhibit the effect of a protein, PCSK9, can lower LDL-cholesterol by 50% or more but require it to be given by injection. Unlike these injectable therapies, MK-0616 is an orally administered PCSK9 inhibitor that can achieve equivalent LDL-C-lowering as the injectable PCSK9 inhibitors and offers potential advantages in the simplicity of dosing, patient preference, and access. The principal objectives of this Phase 3 study are to evaluate the LDL-C-lowering efficacy and safety of MK-0616 in participants with hypercholesterolemia as well as what is hoped to be a reduction in heart attack, stroke and cardiovascular mortality.
Key Eligibility Requirements:
(Please note: Additional eligibility requirements may be assessed at the time of study screening evaluation.)
- Be over 18 years of age and less than 80 years of age
- Has a history of acute coronary syndrome, heart attack, angina pectoris, coronary, carotid, or peripheral artery revascularization with stents or surgical bypass, ischemic stroke, transient ischemic attack, or symptomatic peripheral artery disease (pain in calves with activity) with an LDL-C between 70-160 mg/dl on maximally tolerated statin dose
OR - One of the following conditions with an LDL-C of 70-200 mg/dl on maximally tolerated statin therapy
o Heterozygote for familial hyperlipidemia
o Diabetes
o Age ≥ 40 years with ASCVD risk score ≥ 7.5% based on the Pooled Cohort Equation or equivalent
o Lipoprotein a ≥ 50 mg/dL
o A coronary artery calcium score ≥ 100 Agatston units - Cannot have severe chronic kidney disease (eGFR < 30ml/min/1.73 m2
- Cannot have been on treatment with a PCSK9 inhibitor antibody such as Praluent or Repatha within six months or a PCSK9 siRNA (Lequivo) within one year
PARTICIPATION IN THIS TRIAL CAN BE UP TO THREE YEARS
The information we are providing includes important background on a variety of important cardiovascular conditions and ongoing clinical trials. We encourage you to use this information in discussions with your health care professional. Since enrollment in clinical trials are limited in time, we can’t guarantee their availability at any given time. However, we have continued access to new clinical trial opportunities and will share them as soon as they are available.