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

RECRUITINGPHASE2/PHASE3

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

An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia

NCT07058077•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood. The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results
•Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL
•Is receiving either an optimized daily dose of statin (± nonstatin LLT); or a nonstatin LLT with documented intolerance to at least 2 different statins or refusal of statin therapy by the participant or legally acceptable representative
•Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B

Exclusion Criteria

•Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH
•Has a history of nephrotic syndrome
•Has any clinically significant malabsorption condition based on principal investigator assessment
•Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Locations (21)

Nemours/Alfred I. duPont Hospital for Children ( Site 0001)

Wilmington, Delaware, United States

Children's National Medical Center ( Site 0015)

Washington D.C., District of Columbia, United States

Excel Medical Clinical Trials ( Site 0008)

Boca Raton, Florida, United States

Children's Healthcare of Atlanta Cardiology ( Site 0026)

Atlanta, Georgia, United States

Monash Children s Hospital ( Site 1603)

Clayton, Victoria, Australia

UZ Antwerpen ( Site 0601)

Edegem, Antwerpen, Belgium

Universidade Federal Do Ceara ( Site 0201)

Fortaleza, Ceará, Brazil

Incor - Instituto do Coracao ( Site 0200)

São Paulo, Brazil

Beijing Anzhen Hospital. Capital Medical University ( Site 1917)

Beijing, Beijing Municipality, China

The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)

Hangzhou, Zhejiang, China

Key Dates

Start Date

August 21, 2025

Primary Completion Date

December 4, 2033

Completion Date

January 23, 2037

Last Updated

March 13, 2026

Enrollment

153

ESTIMATED participants

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions

Enlicitide Decanoate

DRUG

Placebo

DRUG

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)

NCT01824238

Heterozygous Familial Hypercholesterolemia (HeFH)

View study

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: March 13, 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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