A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Public ClinicalTrials.gov record NCT07058077. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT07058077
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Merck Sharp & Dohme LLC
- Industry
- Enrollment
- 153 participants
Conditions and interventions
Interventions
- Enlicitide Decanoate Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 20, 2025
- Primary completion
- Dec 3, 2033
- Completion
- Jan 22, 2037
- Last update posted
- May 10, 2026
2025 – 2037
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nemours/Alfred I. duPont Hospital for Children ( Site 0001) | Wilmington | Delaware | 19803 | Recruiting |
| Children's National Medical Center ( Site 0015) | Washington D.C. | District of Columbia | 20010 | Recruiting |
| Excel Medical Clinical Trials ( Site 0008) | Boca Raton | Florida | 33434 | Recruiting |
| Children's Healthcare of Atlanta Cardiology ( Site 0026) | Atlanta | Georgia | 30329 | Recruiting |
| Cincinnati Children's Hospital Medical Center ( Site 0016) | Cincinnati | Ohio | 45229 | Recruiting |
| West Virginia University ( Site 0013) | Morgantown | West Virginia | 26506 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07058077, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 10, 2026 · Synced May 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07058077 live on ClinicalTrials.gov.