# ORION-4 (inclisiran outcome trial)

Study · id `cardio:orion-4` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

> General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here.

The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations.

Also called: ORION-4; HPS-4/TIMI 65/ORION-4

Browse, condition area: Coronary and vascular disease  

## In plain language

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.

## 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.

## Key facts

- Design: Allocation: randomized. Intervention model: parallel. Masking: quadruple. Primary purpose: prevention. (Registry values, in lower case.)
- Phase: Phase 3
- Enrolled: 16124 participants (enrolled count; A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease, snapshot `cardio:ctgov-nct03705234-2026-10-14`, retrieved 2026-10-14)
- Started: 2018-10-30 (actual) (A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease, snapshot `cardio:ctgov-nct03705234-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2026-10 (anticipated) (A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease, snapshot `cardio:ctgov-nct03705234-2026-10-14`, retrieved 2026-10-14)
- Completion: 2049-12 (anticipated) (A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease, snapshot `cardio:ctgov-nct03705234-2026-10-14`, retrieved 2026-10-14)
- Countries: United States; United Kingdom (A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease, snapshot `cardio:ctgov-nct03705234-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "ACTIVE\_NOT\_RECRUITING" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct03705234-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Tests inclisiran: Inclisiran (`cardio:inclisiran`)
- Registry collaborator, named as Novartis Pharmaceuticals: Novartis (`cardio:novartis`)

## Provenance

Content hash: 39e73f5b41c22443b262278d92f65c02d8f2b324d11beb8eb0b8b32ff2677f74
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14