The trial is taking place at:
H

Hillel Yaffe Medical Center | Neurology Department

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

Merck Sharp & Dohme (MSD) logo

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

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

Trial contacts and locations

168

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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