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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 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. The trial reports 20 study locations across 20 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07058077
The ClinicalTrials.gov registry entry for NCT07058077 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 20 distinct geographic areas - top geographies include 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.
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