A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH

Launched by MERCK SHARP & DOHME LLC · Jul 10, 2023

Keywords

ClinConnect Summary

This clinical trial, called the CORALreef study, is testing a new medication called enlicitide decanoate in adults with a specific type of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH). The main goal of the study is to see if this new medication can lower bad cholesterol levels (LDL-C) more effectively than a placebo (a pill with no active medication) after 24 weeks of treatment. Participants in the trial must be between the ages of 65 and 74, have been diagnosed with HeFH, and currently be taking a statin medication to help manage their cholesterol.

To be eligible for this study, participants should have certain cholesterol levels and be on a stable dose of their current cholesterol-lowering treatments. However, individuals with a more severe type of cholesterol condition called homozygous familial hypercholesterolemia, recent heart failure issues, or those undergoing specific cholesterol removal treatments will not be able to participate. Those who join the study can expect to take the study medication or a placebo for 24 weeks while their cholesterol levels are closely monitored to determine the medication's effectiveness and safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
• • Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
• • Is treated with a moderate- or high-intensity statin medication
• • Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change
• Exclusion Criteria:
• • Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
• • Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
• • 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