deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT05952869

A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia.

Sponsor: Merck Sharp & Dohme LLC

Updated 16 times since 2023 Last updated: Feb 5, 2026 Started: Aug 8, 2023 Primary completion: Apr 7, 2025 Completion: Apr 7, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05952869, this PHASE3 trial focuses on Familial Hypercholesterolemia and Hypercholesterolemia and remains completed. Sponsored by Merck Sharp & Dohme LLC, it has been updated 16 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Apr 2024 · 2 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Jun 2025 · 6 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshot~Feb 2026 – present · 5 months · monthly snapshot

Change History

16 versions recorded
  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Dec 2025 — Feb 2026 [monthly]

    Completed PHASE3

  3. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE3

  4. Jun 2025 — Sep 2025 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  5. Dec 2024 — Jun 2025 [monthly]

    Active Not Recruiting PHASE3

Show 11 earlier versions
  1. Sep 2024 — Dec 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Feb 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  6. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE3

  7. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  8. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

  9. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  10. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  11. Aug 2023 — Sep 2023 [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 .