Study

Overview

Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

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.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

2760

Study Start Date:

August 2023

Estimated Study Completion Date:

September 2025

Estimated Primary Completion Date:

September 2025

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

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

Locations

United States Toll Free Number 1-800-770-4674

Daphne, Alabama, 36526
Foley, Alabama, 36535
Phoenix, Arizona, 85020
Banning, California, 92220
Beverly Hills, California, 90211
Sacramento, California, 95821
Washington, District of Columbia, 20009
Boca Raton, Florida, 33434
Coral Gables, Florida, 33134
Fort Myers, Florida, 33912
Hallandale Beach, Florida, 33009
Jacksonville, Florida, 32216
Miramar, Florida, 33027
Tampa, Florida, 33607
Macon, Georgia, 31210
Flossmoor, Illinois, 60422
Evansville, Indiana, 47714
Indianapolis, Indiana, 46260
Lexington, Kentucky, 40509
Louisville, Kentucky, 40213
Slidell, Louisiana, 70458
Rockville, Maryland, 20854
Gulfport, Mississippi, 39503
Hazelwood, Missouri, 63042
Las Vegas, Nevada, 89106
Las Vegas, Nevada, 89119
Albuquerque, New Mexico, 87106
East Syracuse, New York, 13057
New York, New York, 10029
FARGO, North Dakota, 58104
Duncansville, Pennsylvania, 16635
Yardley, Pennsylvania, 19067
Fort Mill, South Carolina, 29707
Greenville, South Carolina, 29615
North Charleston, South Carolina, 29405
Rapid City, South Dakota, 57701
Kingsport, Tennessee, 37660
Knoxville, Tennessee, 37920
Dallas, Texas, 75230
Houston, Texas, 77030
San Antonio, Texas, 78229
Salt Lake City, Utah, 84106
West Jordan, Utah, 84088
Manassas, Virginia, 20110
Newport News, Virginia, 23606
Norfolk, Virginia, 23502
Richmond, Virginia, 23294
Suffolk, Virginia, 23435
Renton, Washington, 98057

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary – MK-0616-013

Study Detail

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