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Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT05202509

Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease (PREVAIL)

Placebo Controlled, Double Blind, Randomized Cardiovascular Outcome Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With ASCVD Not Adequately Controlled Despite Maximally Tolerated Lipid Modifying Therapies

Sponsor: Monash University

Updated 12 times since 2022 Last updated: Jun 3, 2024 Started: Feb 7, 2022 Primary completion: Nov 30, 2026 Completion: Nov 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05202509, this PHASE3 trial focuses on Atherosclerotic Cardiovascular Disease and remains ongoing. Sponsored by Monash University, it has been updated 12 times since 2022, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Study Description(click to expand)

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to evaluate the effect of 10mg Obicetrapib in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy to reduce the risk of cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization. The PREVAIL Study

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to evaluate the effect of 10mg Obicetrapib in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy to reduce the risk of cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization. The PREVAIL Study

Status Flow

~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshotNot Yet Recruiting~Apr 2022 – ~Sep 2022 · 5 months · monthly snapshotRecruiting~Sep 2022 – ~Oct 2022 · 30 days · monthly snapshotRecruiting~Oct 2022 – ~Dec 2022 · 2 months · monthly snapshotRecruiting~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshotRecruiting~Feb 2023 – ~Feb 2024 · 12 months · monthly snapshotRecruiting~Feb 2024 – ~Apr 2024 · 2 months · monthly snapshotRecruiting~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotActive Not Recruiting~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotActive Not Recruiting~Sep 2025 – present · 7 months · monthly snapshotActive Not Recruiting~Jan 2026 – present · 3 months · monthly snapshotActive Not Recruiting

Change History

12 versions recorded
  1. Jan 2026 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Sep 2025 — Present [monthly]

    Active Not Recruiting PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  5. Apr 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

Show 7 earlier versions
  1. Feb 2024 — Apr 2024 [monthly]

    Recruiting PHASE3

  2. Feb 2023 — Feb 2024 [monthly]

    Recruiting PHASE3

  3. Dec 2022 — Feb 2023 [monthly]

    Recruiting PHASE3

  4. Oct 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  5. Sep 2022 — Oct 2022 [monthly]

    Recruiting PHASE3

  6. Apr 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  7. Feb 2022 — Apr 2022 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Monash University
  • NewAmsterdam Pharma
Data source: NewAmsterdam Pharma

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