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A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
NCT05952869 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Enlicitide Decanoate
Study Locations (20)
Florida
- Excel Medical Clinical Trials ( Site 0008) — Boca Raton
- Advanced Pharma Research ( Site 0007) — Cutler Bay
- Progressive Medical Research ( Site 0021) — Port Orange
- Clinical Site Partners LLC, dba CSP Orlando ( Site 0028) — Winter Park
Indiana
- Synexus Clinical Research US - Evansville ( Site 0031) — Evansville
- Franciscan Physician Network - Indiana Heart Physicians ( Site 0040) — Indianapolis
Quebec
- Ecogene-21 ( Site 0510) — Chicoutimi
- Institut de Cardiologie de Montreal ( Site 0506) — Montreal
Alabama
- Alliance for Multispecialty Research, LLC ( Site 0023) — Daphne
Michigan
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001) — Troy
Nebraska
- Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026) — Lincoln
Nevada
- Jubilee Clinical Research ( Site 0030) — Las Vegas
North Carolina
- Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041) — Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2023-08-08 |
| Est. Completion | 2025-04-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05952869
The ClinicalTrials.gov registry entry for NCT05952869 describes a study currently listed as completed. It is categorized as Phase 3, 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 303 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 2 conditions, with Hypercholesterolemia 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: NCT05952869 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Indiana, Quebec. 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 NCT05952869 about?
NCT05952869 is a clinical study titled "A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)". The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density l...
What is the current status of trial NCT05952869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 303 participants. The study started on 2023-08-08. Estimated completion is 2025-04-07.
What conditions does trial NCT05952869 study?
This clinical trial studies the following conditions: Hypercholesterolemia, Familial Hypercholesterolemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05952869?
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 NCT05952869?
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 NCT05952869 being conducted?
This trial has 20 study locations across Alabama, Florida, Indiana, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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