Recruiting
Phase 2
Phase 3

Enlicitide

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07058077

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Enlicitide Decanoate

Placebo

Study Details

Brief 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.

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Study ID

NCT07058077

Start date

Aug 21, 2025

Status verified date

Aug, 2026

Completion date

Jan 23, 2037

Anticipated

Primary completion date

Dec 4, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

Inclusion criteria include, but are not limited to:

  • 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)
  • A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus 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:

Exclusion criteria include, but are not limited to:

  • 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 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

Study Design

Enrollment

153 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Enlicitide Decanoate

Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks.

experimental: Part B: Enlicitide Decanoate

Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks.

placebo comparator: Part B: Placebo

Participants receive placebo orally QD for up to 24 weeks.

experimental: Open-Label Extension: Enlicitide Decanoate

Participants who complete either Part A or Part B may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate QD at a dosage determined by age for up to 3 years.

Interventions

Enlicitide Decanoate

Enlicitide decanoate taken by mouth

Placebo

Placebo tablet matched to enlicitide decanoate taken by mouth

Primary outcome measure

  • Part A: Maximum Plasma Concentration (Cmax) of Enlicitide [ Time Frame: At designated timepoints (up to 24 hours postdose on day 14) ]
  • Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide [ Time Frame: At designated timepoints (up to 24 hours postdose on day 14) ]
  • Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline and Week 24 ]
  • Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 188 weeks ]
  • Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 180 weeks ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

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

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Study Coordinator

302-651-6600

Children's National Medical Center ( Site 0015)

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Study Coordinator

202-476-5000

Excel Medical Clinical Trials ( Site 0008)

Recruiting

Boca Raton, Florida, United States, 33434

Contacts

Study Coordinator

561-529-4356

Children's Healthcare of Atlanta Cardiology ( Site 0026)

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Study Coordinator

404-256-2593

Boston Children's Hospital ( Site 0018)

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Study Coordinator

616-354-3372

Cincinnati Children's Hospital Medical Center ( Site 0016)

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Study Coordinator

513-636-3200

West Virginia University ( Site 0013)

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Study Coordinator

304-598-4000

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-21.