{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:surpass-cvot",
  "owner": "cardio",
  "kind": "study",
  "slug": "surpass-cvot",
  "name": "SURPASS-CVOT: tirzepatide against dulaglutide on major cardiovascular events",
  "aliases": [
    "SURPASS-CVOT"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial of people with type 2 diabetes and heart or blood-vessel disease that compared tirzepatide with dulaglutide, another weekly diabetes injection that has been shown to lower the chance of heart events. Tirzepatide was found to be no worse than dulaglutide for heart attack, stroke and heart-related death. It was not shown to be better.",
  "summary_technical": "Active-comparator, double-blind, noninferiority trial sponsored by Eli Lilly (NCT04255433). 13,299 patients were randomized; the modified intention-to-treat population was 6586 on tirzepatide (up to 15 mg weekly) and 6579 on dulaglutide (1.5 mg weekly). The primary composite (cardiovascular death, myocardial infarction or stroke) occurred in 801 (12.2%) and 862 (13.1%): hazard ratio 0.92 (95.3% CI 0.83 to 1.01; P=0.003 for noninferiority; P=0.09 for superiority).",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": null,
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT04255433",
      "normalized_value": "NCT04255433",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "metabolism",
        "heart"
      ],
      "condition-area": [
        "diabetes-and-metabolic-disease"
      ]
    }
  },
  "payload": {
    "design": "Multicenter, randomized (1:1), double-blind, active-comparator-controlled noninferiority trial with parallel groups. The registry records phase 3 and double masking.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2020-05-29",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2025-06-12",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
    },
    "completion_date": {
      "date": "2025-06-12",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
    },
    "results_first_posted": {
      "date": "2026-07-08",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "AR",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "AU",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "AT",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "BE",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "BR",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "CN",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "CZ",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "FR",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "GR",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "HU",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "IN",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "IL",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "JP",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "MX",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "NL",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "PL",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "PR",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "RO",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "RU",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "SK",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "KR",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "ES",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "SE",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "TW",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "UA",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      },
      {
        "code": "TR",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 13299,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct04255433-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:surpass-cvot-arm-tirzepatide",
        "label": "Tirzepatide",
        "intervention": "cardio:tirzepatide",
        "description": "Weekly subcutaneous tirzepatide, up to 15 mg (registry arm: maximum tolerated dose)."
      },
      {
        "id": "cardio:surpass-cvot-arm-dulaglutide",
        "label": "Dulaglutide 1.5 mg",
        "intervention": null,
        "description": "Weekly subcutaneous dulaglutide 1.5 mg, described in the abstract as an agent shown to reduce the incidence of cardiovascular events."
      }
    ],
    "findings": []
  },
  "content_digest": "b8e0d0811027ab1d547da3026e74448816069da8669a8cdc766c88e36e5466ba",
  "review": {
    "content_digest": "b8e0d0811027ab1d547da3026e74448816069da8669a8cdc766c88e36e5466ba",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests tirzepatide",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:tirzepatide",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct04255433-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Lists type 2 diabetes as its condition",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:type-2-diabetes",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct04255433-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:eli-lilly",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct04255433-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name"
        },
        "primary": false,
        "role": "lead",
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Lists the HbA1c change as a secondary outcome",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:hba1c",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct04255433-2026-10-14",
          "locator": "protocolSection.outcomesModule.secondaryOutcomes[9].measure"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "The Mounjaro label reports this trial in section 14.6",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:mounjaro",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:openfda-label-d2d7da5d-ad07-4228-955f-cf7e355c8cc0-2026-10-14",
          "locator": "results[0].clinical_studies[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/surpass-cvot/",
  "context_path": "api/v1/context/cardio--surpass-cvot.md"
}