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RECRUITING Phase 2

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

NCT07058077 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 153 participants
Start Date 2025-08-21
Est. Completion 2037-01-23
Phase Phase 2

Sponsor

Merck Sharp & Dohme

741 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07058077 reports 20 study locations spanning 20 distinct geographic areas — top geographies include Delaware, District of Columbia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07058077?

The interventions under investigation include: Placebo (DRUG), Enlicitide Decanoate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07058077?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial