{
  "release_id": "5dcd9b263fe17744",
  "id": "cardio:orion-4",
  "owner": "cardio",
  "kind": "study",
  "slug": "orion-4",
  "name": "ORION-4 (inclisiran outcome trial)",
  "aliases": [
    "ORION-4",
    "HPS-4/TIMI 65/ORION-4"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "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.",
  "summary_technical": "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.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT03705234",
      "normalized_value": "NCT03705234",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "condition-area": [
        "coronary-and-vascular-disease"
      ]
    }
  },
  "payload": {
    "design": "Allocation: randomized. Intervention model: parallel. Masking: quadruple. Primary purpose: prevention. (Registry values, in lower case.)",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "ACTIVE_NOT_RECRUITING",
        "snapshot": "cardio:ctgov-nct03705234-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2018-10-30",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03705234-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2026-10",
      "type": "anticipated",
      "snapshot": "cardio:ctgov-nct03705234-2026-10-14"
    },
    "completion_date": {
      "date": "2049-12",
      "type": "anticipated",
      "snapshot": "cardio:ctgov-nct03705234-2026-10-14"
    },
    "results_first_posted": null,
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct03705234-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "cardio:ctgov-nct03705234-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 16124,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct03705234-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:orion-4-arm-1",
        "label": "Inclisiran",
        "intervention": null,
        "description": "Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection at randomization, 3 months and then every 6 months."
      },
      {
        "id": "cardio:orion-4-arm-2",
        "label": "Placebo",
        "intervention": null,
        "description": "Placebo will be administered as SC injections of saline solution at randomization, 3 months and then every 6 months."
      }
    ],
    "findings": []
  },
  "content_digest": "39e73f5b41c22443b262278d92f65c02d8f2b324d11beb8eb0b8b32ff2677f74",
  "review": {
    "content_digest": "39e73f5b41c22443b262278d92f65c02d8f2b324d11beb8eb0b8b32ff2677f74",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests inclisiran",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:inclisiran",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03705234-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "sponsored_by",
        "label": "Registry collaborator, named as Novartis Pharmaceuticals",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:novartis",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03705234-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.collaborators[1].name"
        },
        "primary": false,
        "role": "collaborator",
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/orion-4/",
  "context_path": "api/v1/context/cardio--orion-4.md"
}