Merck launches Phase 3 CORALreef program for PCSK9 inhibitor MK-0616


Pharmaceutical giant Merck has announced the initiation of its groundbreaking Phase 3 clinical program, CORALreef, focusing on MK-0616—a novel, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. MK-0616 is being evaluated for the treatment of adults suffering from hypercholesterolemia. The CORALreef program marks a historic milestone as the first Phase 3 clinical program for an oral PCSK9 inhibitor.

MK-0616 Shows Robust Efficacy in Phase 2b Results

MK-0616 Successfully Reduces LDL Cholesterol Levels in Diverse Risk Groups

The CORALreef Phase 3 program follows stellar Phase 2b results, where MK-0616 significantly reduced LDL cholesterol levels compared to a placebo across participants with a wide spectrum of atherosclerotic cardiovascular disease (ASCVD) risks. This includes individuals who are on high-intensity statin therapy. Dr. Joerg Koglin, Senior Vice President of Global Clinical Development at Merck Research Laboratories, noted that the initiation of this comprehensive Phase 3 program aims to provide an effective oral medication for a broad population, addressing the significant racial, ethnic, and gender disparities in cardiovascular care.

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CORALreef Lipids and CORALreef HeFH Studies Open for Enrollment

Studies to Evaluate Efficacy of MK-0616 in Lowering LDL Cholesterol Levels

Two major registrational Phase 3 studies, CORALreef Lipids and CORALreef HeFH, are currently enrolling participants. Both studies aim to assess the effectiveness of MK-0616 in lowering LDL cholesterol levels and will continue until September 2025. CORALreef Lipids will involve a broad group of participants, including those with at least one major ASCVD event, while CORALreef HeFH focuses on adult participants with heterozygous familial hypercholesterolemia.

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CORALreef Outcomes Study to Commence by End of 2023

Study to Evaluate MK-0616 Efficacy on High Cardiovascular Risk Patients

In addition, Merck plans to initiate the Phase 3 CORALreef Outcomes study by the end of 2023, which is expected to complete by November 2029. The study aims to evaluate the efficacy of MK-0616 in increasing the time to the first occurrence of significant cardiovascular events, in collaboration with the TIMI Study Group—a leading academic research organization in cardiovascular clinical trials.

About MK-0616: The First Oral PCSK9 Inhibitor

MK-0616 Designed to Lower LDL Cholesterol with Daily Pill Regimen

MK-0616 is an investigational, oral PCSK9 inhibitor poised to revolutionize hypercholesterolemia treatment. It is designed to lower LDL cholesterol through the same biological mechanisms as currently approved injectable PCSK9 inhibitors but in a more convenient daily pill form. The CORALreef Phase 3 program plans to enroll around 17,000 participants across its various studies, making it one of the most ambitious programs in hypercholesterolemia treatment to date.

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By spearheading the CORALreef Phase 3 program for MK-0616, Merck solidifies its role as a leading innovator in the treatment of hypercholesterolemia, aiming to improve patient outcomes through cutting-edge oral medication.

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