Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07058077 · ClinicalTrials.gov registry record · Phase 2
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
A Phase 2 study of Heterozygous Familial Hypercholesterolemia (HeFH), sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
- 20
- Study locations
NCT07058077: Recruiting Phase 2 study of Heterozygous Familial Hypercholesterolemia (HeFH), sponsored by Merck Sharp & Dohme.
NCT07058077 is a Phase 2 study of Heterozygous Familial Hypercholesterolemia (HeFH) that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 153 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 20 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07058077, a Phase 2 study of Heterozygous Familial Hypercholesterolemia (HeFH), is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
- 20
- Study locations
Study 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 works to lower cholesterol levels in children more than a placebo.
Primary Outcome
Blood samples will be collected to determine the Cmax of enlicitide.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Enlicitide Decanoate
Study Locations (20)
Delaware
- Nemours/Alfred I. duPont Hospital for Children ( Site 0001) - Wilmington
District of Columbia
- Children's National Medical Center ( Site 0015) - Washington D.C.
Florida
- Excel Medical Clinical Trials ( Site 0008) - Boca Raton
Georgia
- Children's Healthcare of Atlanta Cardiology ( Site 0026) - Atlanta
Victoria
- Monash Children s Hospital ( Site 1603) - Clayton
Antwerpen
- UZ Antwerpen ( Site 0601) - Edegem
Ceará
- Universidade Federal Do Ceara ( Site 0201) - Fortaleza
Other
- Incor - Instituto do Coracao ( Site 0200) - São Paulo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2025-08-21 |
| Est. Completion | 2037-01-23 |
| Phase | Phase 2 |
What NCT07058077 shows while recruiting
NCT07058077 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher).
The record links to 1 condition, with Heterozygous Familial Hypercholesterolemia (HeFH) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07058077 names 20 study sites across 20 states, led by Delaware, District of Columbia, Florida.
Frequently Asked Questions
What is clinical trial NCT07058077 about?
NCT07058077 is a clinical study titled "A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)". 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 ...
What is the current status of trial NCT07058077?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2025-08-21. Estimated completion is 2037-01-23.
What conditions does trial NCT07058077 study?
This clinical trial studies the following conditions: Heterozygous Familial Hypercholesterolemia (HeFH).
What interventions are being tested in trial NCT07058077?
The interventions under investigation include: Placebo (DRUG), Enlicitide Decanoate (DRUG).
Who is sponsoring clinical trial NCT07058077?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07058077 being conducted?
This trial has 20 study locations across Delaware, District of Columbia, Florida, Georgia, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heterozygous Familial Hypercholesterolemia (HeFH)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07058077's enrollment target sits among peer trials
153 449th of 2000 higher than 1,549 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05283265 · 153 participants · NA
Neurophysiological Mechanisms of Language Comprehension
- NCT05554393 · 153 participants · Phase 2
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
- NCT05584501 · 153 participants · NA
ETE Interventions in the Dental Setting
- NCT05714839 · 153 participants · Phase 1
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI