{
  "topic": {
    "stem": "SOTATERCEPT_PAH_AUTO_2",
    "name": "Sotatercept in PAH (broader)",
    "ncts": [
      "NCT06664801",
      "NCT07266519",
      "NCT06925750",
      "NCT04896008",
      "NCT05587712",
      "NCT07218029",
      "NCT03496207",
      "NCT06409026"
    ],
    "drug_patterns": [
      "sotatercept"
    ],
    "condition_patterns": [
      "pulmonary arterial"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT06664801",
        "aact_title": "A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024)",
        "aact_acronym": "LIGHTRAY",
        "start_date": "2024-11-14",
        "primary_completion_date": "2025-11-20",
        "aact_intvs": [
          "sotatercept",
          "background pah therapy"
        ],
        "aact_conditions": [
          "pulmonary arterial hypertension"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Steady-State Average Serum Concentrations of Sotatercept (Cavg)",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT07266519",
        "aact_title": "SIRIUS - Initial Combination Therapy With an Endothelin Receptor Antagonist, a Phosphodiesterase-5 Inhibitor and Sotatercept in Patients With Newly Diagnosed Pulmonary Arterial Hypertension",
        "aact_acronym": "SIRIUS",
        "start_date": "2026-07-01",
        "primary_completion_date": "2028-10-31",
        "aact_intvs": [
          "sotatercept 0.3 mg/kg escalating to 0.7 mg/kg",
          "sotatercept"
        ],
        "aact_conditions": [
          "pulmonary arterial hypertension (pah)"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Assessment of the effect on pulmonary vascular resistance (PVR)",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT06925750",
        "aact_title": "A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)",
        "aact_acronym": "LIGHTRAY EXT",
        "start_date": "2025-05-12",
        "primary_completion_date": "2028-06-16",
        "aact_intvs": [
          "sotatercept",
          "background pah therapy"
        ],
        "aact_conditions": [
          "pulmonary arterial hypertension"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Number of Participants Who Experience One or More Adverse Events (AEs)",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04896008",
        "aact_title": "A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)",
        "aact_acronym": "ZENITH",
        "start_date": "2021-12-01",
        "primary_completion_date": "2024-07-26",
        "aact_intvs": [
          "sotatercept",
          "placebo"
        ],
        "aact_conditions": [
          "pulmonary arterial hypertension"
        ],
        "pmid": "40167274",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1056/NEJMoa2415160",
        "aact_per_arm_counts": {
          "BG000": 86,
          "BG001": 86
        },
        "aact_primary_outcome_measure": "Time to First Confirmed Morbidity or Mortality Event",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "12.8"
          ],
          [
            "OG001",
            "16.3"
          ],
          [
            "OG000",
            "48.7"
          ],
          [
            "OG001",
            "14.3"
          ],
          [
            "OG000",
            "54.7"
          ],
          [
            "OG001",
            "30.2"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT05587712",
        "aact_title": "Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)",
        "aact_acronym": "MOONBEAM",
        "start_date": "2023-01-19",
        "primary_completion_date": "2028-09-21",
        "aact_intvs": [
          "sotatercept"
        ],
        "aact_conditions": [
          "pulmonary arterial hypertension"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Serum Trough Concentration (Ctrough) of Sotatercept",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT07218029",
        "aact_title": "A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)",
        "aact_acronym": "SOTERIA",
        "start_date": "2021-05-12",
        "primary_completion_date": "2028-12-07",
        "aact_intvs": [
          "sotatercept"
        ],
        "aact_conditions": [
          "pulmonary arterial hypertension"
        ],
        "pmid": "39978862",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1183/13993003.01435-2024",
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Number of Participants Who Experience an Adverse Event (AE)",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03496207",
        "aact_title": "A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)",
        "aact_acronym": "PULSAR",
        "start_date": "2018-06-13",
        "primary_completion_date": "2022-03-09",
        "aact_intvs": [
          "placebo",
          "sotatercept",
          "soc"
        ],
        "aact_conditions": [
          "pulmonary arterial hypertension"
        ],
        "pmid": "36041750",
        "pubmed_year": 2023,
        "pubmed_doi": "10.1183/13993003.01347-2022",
        "aact_per_arm_counts": {
          "BG000": 32,
          "BG001": 32,
          "BG002": 42
        },
        "aact_primary_outcome_measure": "Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "14.0"
          ],
          [
            "OG001",
            "15.0"
          ],
          [
            "OG002",
            "31.0"
          ],
          [
            "OG003",
            "36.0"
          ],
          [
            "OG000",
            "1.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG002",
            "1.0"
          ],
          [
            "OG003",
            "3.0"
          ],
          [
            "OG000",
            "2.0"
          ],
          [
            "OG001",
            "0.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT06409026",
        "aact_title": "Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension",
        "aact_acronym": "",
        "start_date": "2024-07-05",
        "primary_completion_date": "2026-03-31",
        "aact_intvs": [
          "sotatercept"
        ],
        "aact_conditions": [
          "pulmonary arterial hypertension"
        ],
        "pmid": "41885673",
        "pubmed_year": 2026,
        "pubmed_doi": "10.1016/j.jacc.2026.02.5103",
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise",
        "aact_outcome_count_rows": []
      }
    }
  ],
  "n_total": 8,
  "n_pass_all": 2,
  "verdict": "VIABLE",
  "pass_rate": 0.25
}