The MK-0616 information Center

Everything about the Novel PCSK9 inhibitor, MK-0616

Merck has launched Phase III clinical trial for MK-0616

About MK-0616

MK-0616 is an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in adults with hypercholesterolemia. Chemically speaking, MK-0616 is a macrocyclic peptide that binds to PCSK9 and inhibits its interaction with LDL receptors.

9

total Clinical Trials

9

Publications on Pubmed

60.9

reductions in LDL-C (%)

3

Lastest Clinic trial Phase

Important Illustrations of MK-0616

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MK-0616 Structure
MK-0616 Phase 2b trial
PCSK9 inhibitors work differently than statins
PCSK9 inhibitors work differently than statins

Major Research Progress

Merck Initiates Phase 3 Clinical Program for Oral PCSK9 Inhibitor Candidate MK-0616

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Merck’s MK-0616, significantly Reduced LDL-C in Patients with Hypercholesterolemia in Phase 2b Study

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Phase 2b Clinical Trial Publication

MK-0616 demonstrated statistically significant and robust dose-dependent, placebo-adjusted reductions in LDL-C of up to 60.9% from baseline at Week 8. It was well tolerated throughout 8 weeks of treatment and an additional 8 weeks of follow-up.

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Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk

The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.

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A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

The main purpose of this study is to assess whether MK-0616 is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing LDL-C in participants with hypercholesterolemia, and to evaluate its safety and tolerability.

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PCSK9 inhibitors 101

Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a protein primarily expressed in human liver. PCSK9 regulates how many LDL receptors you have. Studies have shown that if you have naturally high PCSK9, you are more likely to have high cholesterol.

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What is PCSK9 and how PCSK9 inhibitors work

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