deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03399370

Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10)

A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)

Sponsor: The Medicines Company

Updated 12 times since 2018 Last updated: Sep 8, 2020 Started: Dec 21, 2017 Primary completion: Sep 10, 2019 Completion: Sep 17, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on ASCVD and Elevated Cholesterol, this trial is completed. The trial is conducted by The Medicines Company and has accumulated 12 data snapshots since 2017. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Feb 2018 – ~May 2018 · 3 months · monthly snapshotRecruiting~May 2018 – ~Jun 2018 · 31 days · monthly snapshotActive Not Recruiting~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotActive Not Recruiting~Mar 2019 – ~May 2019 · 2 months · monthly snapshotActive Not Recruiting~May 2019 – ~Oct 2020 · 17 months · monthly snapshotActive Not Recruiting~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

Show 7 earlier versions
  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE3

  2. Oct 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  3. May 2019 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  4. Mar 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  5. Jun 2018 — Mar 2019 [monthly]

    Active Not Recruiting PHASE3

  6. May 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  7. Feb 2018 — May 2018 [monthly]

    Recruiting PHASE3

    First recorded

Dec 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • The Medicines Company
Data source: The Medicines Company

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