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Trial · Interventional

RecruitingPhase 2/3Registry data

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

NCTNCT07058077 (opens ClinicalTrials.gov in a new tab)Other id0616-029Other idU1111-1314-5796Other id2024-519068-42-00Other idjRCT2040260089
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 2/3
Enrollment
153 participants (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Design
Randomized · Quadruple masking
Countries
19 countries

United States, Australia, Belgium, Brazil, Chile, China, Colombia, Czechia, Finland, France, Germany, Mexico, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, United Kingdom

Start
21 Aug 2025
Primary completion
4 Dec 2033 (estimated)
Completion
23 Jan 2037 (estimated)
First posted
10 Jul 2025
Last update posted
7 Oct 2026
Conditions
Heterozygous Familial Hypercholesterolemia (HeFH)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520302035
  1. Ph 2/3

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

    NCT07058077

    21 Aug 2025 to est. 23 Jan 2037

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Enlicitide DecanoateDrug
  • PlaceboDrug

Arms4

  • 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.

Primary outcomes5

Outcomes the sponsor listed as primary.

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

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

    Registry description

    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)

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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(7)

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

    Time frame · Baseline and week 24

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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