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ACTIVE NOT RECRUITING Phase 3

Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

NCT06492291 · View on ClinicalTrials.gov ↗

Study Summary

This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).

Conditions Studied

Interventions

  • DRUG Enlicitide Decanoate

Study Locations (20)

Florida

  • Excel Medical Clinical Trials ( Site 0010) — Boca Raton
  • Alliance for Multispecialty Research, LLC ( Site 0037) — Doral
  • Alliance for Multispecialty Research, LLC ( Site 0056) — Fort Myers
  • Velocity Clinical Research, Hallandale Beach ( Site 0053) — Hallandale
  • Jacksonville Center for Clinical Research ( Site 0025) — Jacksonville
  • South Broward Research ( Site 0012) — Miramar
  • Progressive Medical Research ( Site 0033) — Port Orange
  • Clinical Research Trials of Florida ( Site 0006) — Tampa
  • Clinical Site Partners, LLC dba Flourish Research ( Site 0004) — Winter Park

California

  • National Heart Institute-Research ( Site 0029) — Beverly Hills
  • Clinical Trials Research ( Site 0054) — Sacramento
  • Velocity Clinical Research, Banning ( Site 0023) — San Bernardino

Alabama

  • Alliance for Multispecialty Research, LLC ( Site 0027) — Daphne
  • G&L Research ( Site 0035) — Foley

Indiana

  • Synexus Clinical Research US - Evansville ( Site 0005) — Evansville
  • Midwest Institute For Clinical Research ( Site 0052) — Indianapolis

Arizona

  • Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048) — Phoenix

District of Columbia

  • Emerson Clinical Research Institute ( Site 0017) — Washington D.C.

Georgia

  • East Coast Institute for Research, LLC ( Site 0020) — Macon

Illinois

  • Healthcare Research Network - Chicago ( Site 0051) — Flossmoor

Trial Details

FieldValue
Enrollment Target 3,000 participants
Start Date 2024-08-05
Est. Completion 2028-10-13
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06492291

The ClinicalTrials.gov registry entry for NCT06492291 describes a study currently listed as active not recruiting. 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 3,000 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 Hypercholesterolemia appearing as the primary indexed condition, and to 1 intervention — of which Enlicitide Decanoate 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: NCT06492291 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Alabama. 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 NCT06492291 about?

NCT06492291 is a clinical study titled "Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension". This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).

What is the current status of trial NCT06492291?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 3,000 participants. The study started on 2024-08-05. Estimated completion is 2028-10-13.

What conditions does trial NCT06492291 study?

This clinical trial studies the following conditions: 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 NCT06492291?

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

Who is sponsoring clinical trial NCT06492291?

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 NCT06492291 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. 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