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NCT Number: NCT07058077

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

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.

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Key information

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Monash Children s Hospital ( Site 1603), Clayton, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enlicitide Decanoate

Drug

Enlicitide decanoate taken by mouth

Other names: MK-0616, Enlicitide

Placebo

Drug

Placebo tablet matched to enlicitide decanoate taken by mouth

Primary outcomes

  1. Part A: Maximum Plasma Concentration (Cmax) of Enlicitide

    Time frame: At designated timepoints (up to 24 hours postdose on day 14)

    Blood samples will be collected to determine the Cmax of enlicitide.

  2. 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)

    Blood samples will be collected to determine the AUC0-24 of enlicitide.

  3. Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline and Week 24

    Blood samples will be collected to determine the percent change from baseline in LDL-C.

  4. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 188 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  5. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 180 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Secondary outcomes

  1. Part B: Percent Change from Baseline in Apolipoprotein B (ApoB)

    Time frame: Baseline and week 24

    Blood samples will be collected to determine the percent change from baseline in apolipoprotein B.

  2. Part B: Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)

    Time frame: Baseline and week 24

    Blood samples will be collected to determine the percent change from baseline in non-HDL-C.

  3. Part B: Percent Change from Baseline in Lipoprotein (a) (Lp(a))

    Time frame: Baseline and week 24

    Blood samples will be collected to determine the percent change from baseline in Lp(a).

  4. Part B: Percentage of Participants With LDL-C <130 mg/dL at Week 24

    Time frame: Week 24

    The percentage of participants with LDL-C <130 mg/dL at week 24 will be reported.

  5. Part B: Percentage of Participants With ≥50% LDL-C Reduction from Baseline at Week 24

    Time frame: Baseline and week 24

    The percentage of participants with ≥50% LDL-C reduction from baseline at week 24 will be reported.

  6. Part B: Percentage of Participants With LDL-C <100 mg/dL at Week 24

    Time frame: Week 24

    The percentage of participants with LDL-C <100 mg/dL at week 24 will be reported.

  7. Change in Carotid Intima-media Thickness (cIMT)

    Time frame: Baseline and week 24

    Ultrasound measurements will be performed to determine the change from baseline in cIMT.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2033
Study completion
2037
First posted
Jul 10, 2025
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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