Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT06267560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-13
First Post:
2024-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730804', 'term': 'pelacarsen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Eligible participants will be randomized after the screening period or Guideline recommended SOC implementation period (if needed) in a 2:1 ratio to subcutaneous injections of pelacarsen (TQJ230) 80 mg QM or placebo QM either to be self-administered or administered by caregiver or site personnel approximately every 30 days for up to 12 months.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 422}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT07000695', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in log-transformed Lp(a) concentration from baseline at week 52', 'timeFrame': 'Baseline, week 52', 'description': 'The primary aim of the study is to demonstrate the superiority of pelacarsen to placebo in lowering the Lp(a) level at 12 months of treatment in US Black/African American and US Hispanic participants with established ASCVD and a Lp(a) level of ≥ 125 nmo/L.'}], 'secondaryOutcomes': [{'measure': 'Incidence proportion of study discontinuations due to TEAEs', 'timeFrame': 'Up to 52 weeks', 'description': 'Incidence proportion of study discontinuations due to TEAEs will be provided'}, {'measure': 'Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest', 'timeFrame': 'Up to 52 weeks', 'description': 'Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest will be provided'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elevated Lp(a)', 'Cardiovascular disease', 'Pelacarsen (TQJ230)'], 'conditions': ['Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.', 'detailedDescription': 'CTQJ230A12303 is a randomized, double-blind, placebo-controlled, multi-center, Phase IIIb study to evaluate the efficacy ( measured by reduction of the Lp(a) levels) and safety of pelacarsen (TQJ230) 80mg s.c. QM compared to placebo in US Black/African American and US Hispanic participants, with established atherosclerotic cardiovascular disease (ASCVD) as evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic peripheral artery disease (PAD) and elevated levels of Lp(a).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female US Black/African American and US Hispanic participants 18 to ≤ 80 years of age\n* Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory\n* On Standard of Care (SoC) therapy for risk factors other than Lp(a), including LDL-C (LDL-C lowering therapy dose stable for at least 30 days), elevated blood pressure and diabetes, at the randomization visit according to local practice/guidelines.\n* Established ASCVD disease defined as documented:\n\n * Coronary heart disease (CHD) and/or\n * Cerebrovascular disease (CVD) and/or\n * Peripheral arterial disease (PAD):\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Heart failure New York Heart Association (NYHA) class IV\n* History of malignancy of any organ system\n* History of hemorrhagic stroke or other major bleeding\n* Platelet count \\<140,000 per mm3\n* Active liver disease or hepatic dysfunction\n* Significant kidney disease\n* Pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT06267560', 'briefTitle': 'Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen (TQJ230) in US Black/African American & Hispanic Patient Populations With Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease', 'orgStudyIdInfo': {'id': 'CTQJ230A12303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQJ230', 'description': 'TQJ230 80mg QM s.c.', 'interventionNames': ['Drug: TQJ230']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TQJ230', 'type': 'DRUG', 'otherNames': ['pelacarsen'], 'description': 'TQJ230 80mg QM s.c.', 'armGroupLabels': ['TQJ230']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Parkway Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus', 'geoPoint': {'lat': 33.53865, 'lon': 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researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}