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

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Hypercholesterolemia; Familial Hypercholesterolemia

Treatments: Drug: MK-0616; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05952856

2022-502777-42 (Registry Identifier)

jRCT2031230320 (Registry Identifier)

0616-013

MK-0616-013 (Other Identifier)

U1111-1285-4164 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,760 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,760 participants in 2 patient groups, including a placebo group

MK-0616

Experimental group

Description:

Participants will receive 20 mg of MK-0616 orally once daily (QD) for up to 52 weeks.

Treatment:

Drug: MK-0616

Placebo

Placebo Comparator group

Description:

Participants will receive MK-0616-matching placebo orally QD for up to 52 weeks.

Treatment:

Drug: Placebo