deltatrials
Completed PHASE3 INTERVENTIONAL 4-arm NCT06450366

A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

Sponsor: Merck Sharp & Dohme LLC

Updated 11 times since 2024 Last updated: May 22, 2025 Started: Jul 8, 2024 Primary completion: Feb 14, 2025 Completion: Mar 28, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Hypercholesterolemia and is currently completed. Merck Sharp & Dohme LLC leads this study, which shows 11 recorded versions since 2024 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Mar 2025 · 59 days · monthly snapshotActive Not Recruiting~Mar 2025 – ~Jun 2025 · 3 months · monthly snapshotActive Not Recruiting~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshotCompleted~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshotCompleted~Dec 2025 – present · 7 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Dec 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE3

  3. Jun 2025 — Sep 2025 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Mar 2025 — Jun 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2025 — Mar 2025 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

Show 6 earlier versions
  1. Dec 2024 — Jan 2025 [monthly]

    Recruiting PHASE3

  2. Nov 2024 — Dec 2024 [monthly]

    Recruiting PHASE3

  3. Oct 2024 — Nov 2024 [monthly]

    Recruiting PHASE3

  4. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  5. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  6. Jul 2024 — Aug 2024 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck Sharp & Dohme LLC
Data source: Merck Sharp & Dohme LLC

For direct contact, visit the study record on ClinicalTrials.gov .