A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

• Status: Active, not recruiting
• Trial end date: 2025-09-24
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with hypercholesterolemia. The primary hypothesis is that MK-0616 is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC

Criteria

Inclusion Criteria:

• Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.

• 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:

• 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 without adequate washout