Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-02 @ 3:19 AM
Study NCT ID:
NCT06925750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542017', 'term': 'ACE-011'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience One or More Adverse Events (AEs)', 'timeFrame': 'Up to approximately 28 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.'}, {'measure': 'Number of Participants who Discontinue Study Intervention Due to an AE', 'timeFrame': 'Up to approximately 24 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH). Sotatercept is a study medicine that is designed to treat PAH.\n\nA past study, MK-7962-024 (LIGHTRAY) (NCT06664801), learned about the safety and effects of sotatercept in people with PAH. One of the goals of that study was to learn about sotatercept when given at a dose (amount) based on the weight range a person is in (weight-banded doses) compared to when given based on a person's exact weight.\n\nThis is an extension study, which means people who took part in MK-7962-024 (LIGHTRAY) may be able to join this study. In this extension study, people will get weight-banded doses of sotatercept. The main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has completed the treatment period of study MK-7962-024 (LIGHTRAY) (including Visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into MK-7962-031 (LIGHTRAY EXTENSION)\n* Has not started treatment with commercially available sotatercept\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n\\- Has current exposure or is planning to begin treatment with an activin signaling inhibitor (other than sotatercept)'}, 'identificationModule': {'nctId': 'NCT06925750', 'acronym': 'LIGHTRAY EXT', 'briefTitle': 'A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-label Extension Study to Evaluate Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care', 'orgStudyIdInfo': {'id': '7962-031'}, 'secondaryIdInfos': [{'id': 'MK-7962-031', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2024-518687-12-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1314-0614', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': 'jRCT2061250021', 'type': 'REGISTRY', 'domain': 'jRCT (Japan Registry of Clinical Trials)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weight-banded sotatercept dosing', 'description': 'Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method and will continue treatment for up to 24 months. All eligible participants will receive weight-banded dosing at the dosing level (initial or maintenance) at which they finished MK-7962-024 (LIGHTRAY). Participants will continue to take their background PAH therapy during the study.', 'interventionNames': ['Biological: Sotatercept', 'Drug: Background PAH Therapy']}], 'interventions': [{'name': 'Sotatercept', 'type': 'BIOLOGICAL', 'otherNames': ['MK-7962', 'ACE-011'], 'description': 'SC injection administered every 3 weeks', 'armGroupLabels': ['Weight-banded sotatercept dosing']}, {'name': 'Background PAH Therapy', 'type': 'DRUG', 'description': 'Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists', 'armGroupLabels': ['Weight-banded sotatercept dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center ( Site 1928)', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': 'B1904AAW', 'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro Medico Capital ( Site 0002)', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'B7600FZO', 'city': 'Mar del Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': 'X5800AEV', 'city': 'Río Cuarto', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Instituto Medico Rio Cuarto ( Site 0010)', 'geoPoint': {'lat': -33.13044, 'lon': -64.35272}}, {'zip': 'W3400AMZ', 'city': 'Corrientes', 'country': 'Argentina', 'facility': 'Instituto de Cardiologia Juana F. 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