Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000686', 'term': 'Amyloidosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite outcome of all-cause mortality and recurrent cardiovascular [CV] events (CV hospitalizations and urgent heart failure [HF] visits)', 'timeFrame': 'Baseline to end of double-blind period (estimated 32 months, maximum 5 years)', 'description': 'All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) will be compared between treatment groups using an Andersen-Gill model.'}], 'secondaryOutcomes': [{'measure': 'Time to first CV event (CV hospitalizations and urgent HF visits) or all-cause mortality', 'timeFrame': 'Baseline to end of double-blind period (estimated 32 months, maximum 5 years)'}, {'measure': 'All-cause mortality', 'timeFrame': 'Baseline to end of double-blind period (estimated 32 months, maximum 5 years)'}, {'measure': 'Recurrent CV events (CV hospitalizations and urgent HF visits)', 'timeFrame': 'Baseline to end of double-blind period (estimated 32 months, maximum 5 years)'}, {'measure': 'Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)', 'timeFrame': 'Baseline to Month 30', 'description': 'The KCCQ is a 23-item self-administered questionnaire quantifying 6 domains (symptoms, physical function, quality of life, social limitation, self-efficacy, and symptom stability) and 2 summary scores (clinical and overall summary \\[OS\\]). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ATTR-CM', 'ATTR amyloidosis with cardiomyopathy', 'ATTR', 'Heriditary ATTR', 'hATTR', 'Wild-type ATTR', 'wATTR', 'Cardiomyopathy', 'Amyloidosis', 'TTR', 'Transthyretin', 'TTR-mediated amyloidosis', 'RNAi', 'RNAi therapeutic', 'TTR cardiomyopathy', 'V122i', 'TTR amyloidosis'], 'conditions': ['Transthyretin Amyloidosis With Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\n* Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events\n* Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death\n* Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Has documented diagnosis of ATTR amyloidosis with cardiomyopathy including those with hereditary ATTR (hATTR) or wild-type ATTR (wATTR) amyloidosis.\n* Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF or signs and symptoms that require treatment with a diuretic.\n* Has screening N-terminal prohormone B-type natriuretic peptide (NT-proBNP) \\>300 ng/L and \\<8500 ng/L; In patients with permanent or persistent atrial fibrillation, screening NT-proBNP \\>600 ng/L and \\<8500 ng/L.\n* Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis) and may be receiving background therapy for HF at the discretion of the Investigator.\n\nExclusion Criteria\n\n* Has New York Heart Association (NYHA) Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3.\n* Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV.\n* Has an estimated glomerular filtration rate eGFR of \\<30 mL/min/1.73m\\^2 at screening.\n* Has received prior or currently receiving TTR-lowering therapy'}, 'identificationModule': {'nctId': 'NCT07052903', 'briefTitle': 'TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alnylam Pharmaceuticals'}, 'officialTitle': 'TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Transthyretin-Mediated Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)', 'orgStudyIdInfo': {'id': 'ALN-TTRSC04-003'}, 'secondaryIdInfos': [{'id': '2024-519917-72-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo administered subcutaneously (SC) once every 6 months (q6M) during the double-blind (DB) period, followed by nucresiran 300 mg administered SC q6M during the open-label extension (OLE) period.', 'interventionNames': ['Drug: Nucresiran', 'Drug: Sterile Normal Saline (0.9% NaCl)']}, {'type': 'EXPERIMENTAL', 'label': 'Nucresiran 300 mg', 'description': 'Participants will receive nucresiran 300 mg administered SC Q6M during the DB period, followed by nucresiran 300 mg administered SC q6M during the OLE period.', 'interventionNames': ['Drug: Nucresiran']}], 'interventions': [{'name': 'Nucresiran', 'type': 'DRUG', 'otherNames': ['ALN-TTRSC04'], 'description': 'Nucresiran 300 mg administered SC q6M', 'armGroupLabels': ['Nucresiran 300 mg', 'Placebo']}, {'name': 'Sterile Normal Saline (0.9% NaCl)', 'type': 'DRUG', 'description': 'Sterile Normal Saline (0.9% NaCl) administered SC once q6M', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '30084', 'city': 'Tucker', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.85455, 'lon': -84.21714}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 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119.30611}}, {'zip': '510080', 'city': 'Guangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '310014', 'city': 'Hangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '200025', 'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '518053', 'city': 'Shenzhen', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '76031', 'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67091', 'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'facility': 'Clinical Trial 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'state': 'V', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'state': 'V', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '31008', 'city': 'Pamplona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '4051', 'city': 'Basel', 'state': 'Canton of Basel-City', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '1205', 'city': 'Geneva', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '6000', 'city': 'Lucerne', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'zip': '40705', 'city': 'Taichung', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': 'B15 2SQ', 'city': 'Birmingham', 'state': 'BIR', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CF15 9SS', 'city': 'Cardiff', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'M15 6SE', 'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Clinical Trial Information Line', 'role': 'CONTACT', 'email': 'clinicaltrials@alnylam.com', 'phone': '1-877-ALNYLAM'}, {'name': 'Clinical Trial Information Line', 'role': 'CONTACT', 'email': 'clinicaltrials@alnylam.com', 'phone': '1-877-256-9526'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alnylam Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU.\n\nAccess to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, a planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more.\n\nRequests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alnylam Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}