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Looking for participantsPhase2/Phase3

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT07058077

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Enlicitide Decanoate (drug), Placebo (drug)
How long the study runs
Study runs about 137 months (dates as stated)
About the drug or intervention
Enlicitide Decanoate — drug: Enlicitide decanoate taken by mouth · Placebo — drug: Placebo tablet matched to enlicitide decanoate taken by mouth
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
6 Years to 17 Years
Who
All
Number of participants
153
Started
2025-08-21
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for heterozygous familial hypercholesterolemia (hefh)
  • • Phase2/Phase3 - 153 participants
  • • 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

Who can take part?

  • • Ages 6 Years to 17 Years
  • • Diagnosed with heterozygous familial hypercholesterolemia (hefh)

Where?

  • • Birmingham - Birmingham Childrens Hospital ( Site 1501)
  • • Sheffield - Sheffield Childrens Hospital ( Site 1503)
  • • Southampton - Southampton General Hospital ( Site 1502)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Heterozygous Familial Hypercholesterolemia (HeFH)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 6 Years - 17 Years
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓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)

Who cannot take part

  • ✗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,...
  • ✗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...
See the full criteria
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

Where Is This Study? (3 UK sites)

Birmingham Childrens Hospital ( Site 1501)

Birmingham B4 6NH, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441213338504

Sheffield Childrens Hospital ( Site 1503)

Sheffield S10 2TH, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441142717000

Southampton General Hospital ( Site 1502)

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442381204989

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10