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A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT05952869•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (59)

Alliance for Multispecialty Research, LLC ( Site 0023)

Daphne, Alabama, United States

Excel Medical Clinical Trials ( Site 0008)

Boca Raton, Florida, United States

Advanced Pharma Research ( Site 0007)

Cutler Bay, Florida, United States

Progressive Medical Research ( Site 0021)

Port Orange, Florida, United States

Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)

Winter Park, Florida, United States

Synexus Clinical Research US - Evansville ( Site 0031)

Evansville, Indiana, United States

Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)

Indianapolis, Indiana, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)

Troy, Michigan, United States

Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)

Lincoln, Nebraska, United States

Jubilee Clinical Research ( Site 0030)

Las Vegas, Nevada, United States

Key Dates

Start Date

August 8, 2023

Primary Completion Date

April 7, 2025

Completion Date

April 7, 2025

Last Updated

February 24, 2026

Enrollment

303

ACTUAL participants

Conditions

HypercholesterolemiaFamilial Hypercholesterolemia

Interventions

Enlicitide Decanoate

DRUG

Placebo

DRUG

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

NCT07058077

Heterozygous Familial Hypercholesterolemia (HeFH)

View study

RECRUITINGNA

Screening for Familial Hypercholesterolemia in Children

NCT06555120

Hypercholesterolemia, Familial

View study

RECRUITING

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Screening for Familial Hypercholesterolemia in Children

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy

Causes and Natural History of Dyslipidemias

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