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Clinical Trial NCT07058077 for Heterozygous Familial Hypercholesterolemia (HeFH) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Merck Sharp & Dohme LLCA Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029) Phase 2, Phase 3 153 Adolescent
Clinical Trial NCT07058077 is designed to study Treatment for Heterozygous Familial Hypercholesterolemia (HeFH). It is a Phase 2 Phase 3 interventional study that is recruiting, having started on August 21, 2025, with plans to enroll 153 participants. Led by Merck Sharp & Dohme LLC, it is expected to complete by January 23, 2037. The latest data from ClinicalTrials.gov was last updated on March 13, 2026.
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 wor...
Show MoreOfficial 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
Conditions
Heterozygous Familial Hypercholesterolemia (HeFH)Other Study IDs
- 0616-029
- U1111-1314-5796 (Registry Identifier) (UTN)
- 2024-519068-42-00 (Registry Identifier) (EU CT)
NCT ID Number
Start Date (Actual)
2025-08-21
Last Update Posted
2026-03-13
Completion Date (Estimated)
2037-01-23
Enrollment (Estimated)
153
Study Type
Interventional
PHASE
Phase 2
Phase 3
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPart A: Enlicitide Decanoate Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks. | Enlicitide Decanoate Enlicitide decanoate taken by mouth |
ExperimentalPart B: Enlicitide Decanoate Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks. | Enlicitide Decanoate Enlicitide decanoate taken by mouth |
Placebo ComparatorPart B: Placebo Participants receive placebo orally QD for up to 24 weeks. | Placebo Placebo tablet matched to enlicitide decanoate taken by mouth |
ExperimentalOpen-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. | Enlicitide Decanoate Enlicitide decanoate taken by mouth |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Part A: Maximum Plasma Concentration (Cmax) of Enlicitide | Blood samples will be collected to determine the Cmax of enlicitide. | 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 | Blood samples will be collected to determine the AUC0-24 of enlicitide. | At designated timepoints (up to 24 hours postdose on day 14) |
Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) | Blood samples will be collected to determine the percent change from baseline in LDL-C. | Baseline and Week 24 |
Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 188 weeks |
Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 180 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Part B: Percent Change from Baseline in Apolipoprotein B (ApoB) | Blood samples will be collected to determine the percent change from baseline in apolipoprotein B. | Baseline and week 24 |
Part B: Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) | Blood samples will be collected to determine the percent change from baseline in non-HDL-C. | Baseline and week 24 |
Part B: Percent Change from Baseline in Lipoprotein (a) (Lp(a)) | Blood samples will be collected to determine the percent change from baseline in Lp(a). | Baseline and week 24 |
Part B: Percentage of Participants With LDL-C <130 mg/dL at Week 24 | The percentage of participants with LDL-C \<130 mg/dL at week 24 will be reported. | Week 24 |
Part B: Percentage of Participants With ≥50% LDL-C LDL-C Reduction from Baseline at Week 24 | The percentage of participants with ≥50% LDL-C reduction from baseline at week 24 will be reported. | Baseline and week 24 |
Part B: Percentage of Participants With LDL-C <100 mg/dL at Week 24 | The percentage of participants with LDL-C \<100 mg/dL at week 24 will be reported. | Week 24 |
Change in Carotid Intima-media Thickness (cIMT) | Ultrasound measurements will be performed to determine the change from baseline in cIMT. | Baseline and week 24 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
6 Years
Eligible Sexes
All
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); or a nonstatin LLT with documented intolerance to at least 2 different statins or 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 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 principal 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
Merck Sharp & Dohme LLC707 active studies to exploreStudy Central Contact
Contact: Toll Free Number, 1-888-577-8839, [email protected]
21 Study Locations in 12 Countries
Sheffield Childrens Hospital ( Site 1503), Sheffield, S10 2TH, United Kingdom
Study Coordinator, Contact, +441142717000
Recruiting
Uusimaa
New Childrens Hospital ( Site 0800), Helsinki, Uusimaa, 00029, Finland
Study Coordinator, Contact, +358 9 4711
Recruiting
North Holland
Amsterdam UMC, locatie AMC ( Site 1000), Amsterdam, North Holland, 1105 AZ, Netherlands
Study Coordinator, Contact, +31205666360
Recruiting
Antwerpen
UZ Antwerpen ( Site 0601), Edegem, Antwerpen, 2650, Belgium
Study Coordinator, Contact, +323 821 32 51
Recruiting
Delaware
Nemours/Alfred I. duPont Hospital for Children ( Site 0001), Wilmington, Delaware, 19803, United States
Study Coordinator, Contact, 302-651-6600
Recruiting
District of Columbia
Children's National Medical Center ( Site 0015), Washington D.C., District of Columbia, 20010, United States
Study Coordinator, Contact, 202-476-5000
Recruiting
Florida
Excel Medical Clinical Trials ( Site 0008), Boca Raton, Florida, 33434, United States
Study Coordinator, Contact, 561-529-4356
Recruiting
Georgia
Children's Healthcare of Atlanta Cardiology ( Site 0026), Atlanta, Georgia, 30329, United States
Study Coordinator, Contact, 404-256-2593
Recruiting
Victoria
Monash Children s Hospital ( Site 1603), Clayton, Victoria, 3168, Australia
Study Coordinator, Contact, +61385723000
Recruiting
Ceará
Universidade Federal Do Ceara ( Site 0201), Fortaleza, Ceará, 60430270, Brazil
Study Coordinator, Contact, +558533668590
Recruiting
Incor - Instituto do Coracao ( Site 0200), São Paulo, 05403900, Brazil
Study Coordinator, Contact, +551126615450
Recruiting
Beijing Municipality
Beijing Anzhen Hospital. Capital Medical University ( Site 1917), Beijing, Beijing Municipality, 100029, China
Study Coordinator, Contact, 010-64412431
Recruiting
Zhejiang
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905), Hangzhou, Zhejiang, 310057, China
Study Coordinator, Contact, 0571-86036545
Recruiting
Atlántico
Clinica de la Costa S.A.S. ( Site 0400), Barranquilla, Atlántico, 080020, Colombia
Study Coordinator, Contact, +57 3133894240
Recruiting
Departamento de Córdoba
Oncomédica S.A.S ( Site 0401), Montería, Departamento de Córdoba, 230002, Colombia
Study Coordinator, Contact, +57 3135342052
Recruiting
Santander Department
Fundación Cardiovascular de Colombia ( Site 0402), Piedecuesta, Santander Department, 681017, Colombia
Study Coordinator, Contact, +573203400438
Recruiting
Valle del Cauca Department
Fundacion Valle del Lili ( Site 0403), Cali, Valle del Cauca Department, 760032, Colombia
Study Coordinator, Contact, +573166237452
Recruiting
Canterbury
New Zealand Clinical Research (Christchurch) ( Site 1700), Christchurch, Canterbury, 8011, New Zealand
Study Coordinator, Contact, NZCR +6433729477
Recruiting
Central Singapore
National University Hospital-Paediatrics ( Site 1800), Singapore, Central Singapore, 117599, Singapore
Study Coordinator, Contact, +6567795555
Recruiting
Asturias, Principado de
Hospital Universitario Central de Asturias ( Site 1303), Oviedo, Asturias, Principado de, 33011, Spain
Study Coordinator, Contact, +34985108000
Recruiting
Navarre
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302), Pamplona, Navarre, 31009, Spain
Study Coordinator, Contact, +34660021505
Recruiting