Tests enlicitide decanoate to lower cholesterol in children with familial high cholesterol
Tests enlicitide decanoate against a placebo in children with inherited high cholesterol.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Singapore, SingaporeSee the siteAlso in 20 other countries, 55 sites
- Trial code
- NCT07058077
- EU 2024-519068-42-00
- JRCT2040260089
- U1111-1314-5796
- Registry title
- A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 153 people, planned
- Started
- 21 Aug 2025
- Expected to end
- 23 Jan 2037
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Enlicitide Decanoate
- Placebo
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers aged 6 to 17 with possible or definite heterozygous familial hypercholesterolemia (HeFH) and high LDL cholesterol, who are already on cholesterol-lowering treatment.
- Age
- 6 Years to 17 Years
- Sex
- All sexes can join.
- Disease stage
- Possible or definite HeFH, diagnosed by a locally accepted method or by genetic testing. Fasted LDL-C of 130 mg/dL (3.4 mmol/L) or higher.
- Earlier treatment
- Must be taking an optimized daily dose of statin (with or without other cholesterol-lowering treatment), or other cholesterol-lowering treatment if intolerant to at least 2 different statins, or to 1 statin plus refusal of statin therapy. Doses must be stable for at least 30 days before screening. Cannot have used certain other cholesterol-lowering medicines, including PCSK9 inhibitors, without enough washout time.
- Biomarker or test result
- Fasted LDL-C of 130 mg/dL (3.4 mmol/L) or higher, measured by the central laboratory.
Main reasons for not taking part
- History of homozygous, compound heterozygous or double heterozygous familial hypercholesterolemia
- History of nephrotic syndrome
- Any clinically significant malabsorption condition
- Current or past use of certain other cholesterol-lowering medicines, including PCSK9 inhibitors, without enough washout
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Where in Singapore
Also in 20 other countries, 55 sites
- National University Hospital-Paediatrics (Site 1800)Singapore, SingaporeContact: Study CoordinatorTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 4 groups in the trial
- Part A: Enlicitide DecanoateTreatment being tested
Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks.
Treatment: Enlicitide Decanoate
- Part B: Enlicitide DecanoateTreatment being tested
Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks.
Treatment: Enlicitide Decanoate
- Part B: PlaceboPlacebo, for comparison
Participants receive placebo orally QD for up to 24 weeks.
Treatment: Placebo
- Open-Label Extension: Enlicitide DecanoateTreatment being tested
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.
Treatment: Enlicitide Decanoate
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official 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
- Plain-language title
- Tests enlicitide decanoate to lower cholesterol in children with familial high cholesterolGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07058077, who can take part
- Record updated
- 12 November 2026