Cardiovascular Atlas
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ORION-4 (inclisiran outcome trial)

A large trial led by the University of Oxford that tests whether inclisiran, an injection that lowers LDL cholesterol, reduces heart attacks, strokes and other events in people with atherosclerotic cardiovascular disease. It has not reported results. The registry gives primary completion as estimated for October 2026.

Also called ORION-4 · HPS-4/TIMI 65/ORION-4

  • Study
  • In this atlas

Overview

Design
Allocation: randomized. Intervention model: parallel. Masking: quadruple. Primary purpose: prevention. (Registry values, in lower case.)
Phase
Phase 3
Enrolled
  • 16,124 participants (enrolled count) (A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease, retrieved )
Sponsor
  • Novartis Registry collaborator, named as Novartis Pharmaceuticals
Funder
Not recorded
Registry
  • NCT NCT03705234
Started
(actual) (A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease, retrieved )
Primary completion
(anticipated) (A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease, retrieved )
Completion
(anticipated) (A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease, retrieved )
Countries
United States, United Kingdom (A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease, retrieved )
Care setting
Not reported
Registry status
  • “ACTIVE_NOT_RECRUITING” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Phase 3, randomized, double-blind, placebo-controlled trial (NCT03705234), 16,124 participants enrolled, started 2018-10-30; the registry gives primary completion as estimated 2026-10 and completion as estimated 2049-12, and shows no results posted. Lead sponsor University of Oxford; collaborators the TIMI Study Group and Novartis Pharmaceuticals. A PubMed title search on 2026-10-14 found a design paper (Am Heart J, 2026) and no results paper. These expected dates are registry dates and stay on this record; no sponsor statement of an expected readout date was found.

Arms

  • Inclisiran

    Intervention None named

    Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection at randomization, 3 months and then every 6 months.

  • Placebo

    Intervention None named

    Placebo will be administered as SC injections of saline solution at randomization, 3 months and then every 6 months.

Findings

No findings are published for this study.

Record details

Record id
cardio:orion-4
Content hash
39e73f5b41c22443b262278d92f65c02d8f2b324d11beb8eb0b8b32ff2677f74