Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-03 @ 9:12 AM
Study NCT ID:
NCT07037459
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2025-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5056}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2025-06-16', 'studyFirstSubmitQcDate': '2025-06-16', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events', 'timeFrame': 'Up to approximately 35 months', 'description': 'Heart Failure events include: hospitalization for HF or urgent HF visits.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) for Participants with Baseline KCCQ-CSS Score ≤ 80', 'timeFrame': 'Baseline and Week 48', 'description': "The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life."}, {'measure': 'Change from Baseline in the KCCQ Total Symptom Score (TSS) for Participants with Baseline KCCQ-CSS Score ≤ 80', 'timeFrame': 'Baseline and Week 48', 'description': "The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life."}, {'measure': 'Total Number of HF Events Including First and Recurrent HF Events', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Occurrence of a Composite Endpoint Consisting of: Myocardial Infarction (MI), Ischemic Stroke, CV Death (Major Adverse Cardiac Events), or HF Events', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Event of a Composite Nephropathy Endpoint', 'timeFrame': 'Up to approximately 35 months', 'description': 'The composite nephropathy endpoint consists of: persistent macroalbuminuria, persistent ≥ 40% reduction in estimated glomerular filtration rate (eGFR), onset of persistent eGFR \\< 15 mL/min/1.73 m\\^2, initiation of chronic renal replacement therapy (dialysis or transplantation), CV or renal death.'}, {'measure': 'Change in eGFR Slope (Total)', 'timeFrame': 'Baseline up to approximately 35 months'}, {'measure': 'Change in eGFR Slope (Chronic)', 'timeFrame': 'From 4 months up to approximately 35 months'}, {'measure': 'Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to the First HF Event', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Change from Baseline in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in the Waist Circumference (cm)', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in the Urine Albumin-to-creatinine Ratio (uACR)', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in the Hemoglobin A1c (HbA1c [%, mmol/mol]) in Participants with T2DM', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in the High-sensitivity C Reactive Protein (hs-CRP)', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in the Body Weight (kg)', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in Total Cholesterol', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in Non-high-density Lipoprotein Cholesterol (non-HDL-C)', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C), HDL-C, Triglycerides (TG), Very Low-density Lipoprotein Cholesterol (VLDL-C)', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Total All-cause Hospitalizations (First and Recurrent Time to Event)', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Number of Participants Achieving ≥ 5-point Change in KCCQ-CSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80', 'timeFrame': 'Baseline and Week 48', 'description': "The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life."}, {'measure': 'Number of Participants Achieving ≥ 10-point Change in KCCQ-CSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80', 'timeFrame': 'Baseline and Week 48', 'description': "The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life."}, {'measure': 'Number of Participants Achieving an Anchor-based Change in KCCQ-CSS Score From Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80', 'timeFrame': 'Baseline and Week 48', 'description': "The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Change (PGI-C) can be used as anchors to estimate within-patient change in the KCCQ-CSS score."}, {'measure': 'Number of Participants Achieving ≥ 5-point Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80', 'timeFrame': 'Baseline and Week 48', 'description': "The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life."}, {'measure': 'Number of Participants Achieving ≥ 10-point Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80', 'timeFrame': 'Baseline and Week 48', 'description': "The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life."}, {'measure': 'Number of Participants Achieving an Anchor-based Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80', 'timeFrame': 'Baseline and Week 48', 'description': "The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The PGI-S and PGI-C can be used as anchors to estimate within-patient change in the KCCQ-CSS score."}, {'measure': 'Time to All-cause Death', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to CV Death', 'timeFrame': 'Up to Approximately 35 Months'}, {'measure': 'Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Plasma Concentration of Maridebart Cafraglutide', 'timeFrame': 'Week 72'}, {'measure': 'Change from Baseline in N-terminal Pro B Type Natriuretic Peptide (NT-proBNP)', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Time to New Onset of Atrial Fibrillation (AF) or Atrial Flutter (AFL) in Participants Without a History of AF or AFL at Baseline', 'timeFrame': 'Baseline and up to approximately 35 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Obesity', 'Maridebart Cafraglutide', 'AMG 133', 'MariTide'], 'conditions': ['Heart Failure With Preserved Ejection Fraction', 'Heart Failure With Mildly Reduced Ejection Fraction', 'Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part study with a double-blind period and an open-label extension (OLE). The study is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* BMI ≥ 30 kg/m\\^2.\n* HF diagnosed for at least 30 days before screening with New York Heart Association (NYHA) Class II-IV.\n* Managed with HF standard of care therapies.\n* Left ventricular ejection fraction (LVEF) of \\> 40%.\n* Elevated NT-proBNP.\n* Participants must have at least one of the following:\n\n 1. Structural heart disease OR\n 2. Documented hospitalization with a primary diagnosis of decompensated HF within 12 months before randomization OR\n 3. Evidence of elevated filling pressures within 12 months before randomization.\n\nExclusion Criteria:\n\n* History of any of the following within 60 days before screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.\n* HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular heart disease, or clinically significant congenital heart disease.\n* Any lifetime history of LVEF ≤ 40%.\n* Currently hospitalized with acute decompensated HF or hospitalization with a primary diagnosis of decompensated HF within 30 days before screening.\n* Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.\n* For participants with a prior diagnosis of T2DM at screening:\n\n 1. HbA1c \\> 10.0%\n 2. Uncontrolled diabetes requiring immediate therapy\n 3. History of diabetic ketoacidosis or hyperosmolar state/coma\n 4. One or more episodes of severe hypoglycemia within 6 months before screening and/or history of hypoglycemia unawareness\n 5. History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.\n* SBP ≥ 180 mmHg , or on three or more blood pressure-lowering drugs with a SBP \\> 160 mmHg.\n* History of chronic pancreatitis or acute pancreatitis in the 180 days before screening.\n* Family (or personal) history of medullary thyroid carcinoma or MEN-2.\n* eGFR \\< 20 mL/min/1.73 m\\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.\n* Calcitonin ≥ 50 ng/L (pg/mL) at screening.\n* Acute or chronic hepatitis.\n* Any of the following psychiatric history:\n\n 1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years before screening\n 2. Lifetime history of suicide attempt\n 3. History of non-suicidal self-injury within 5 years before screening.\n* History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the study.\n* Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the study.'}, 'identificationModule': {'nctId': 'NCT07037459', 'acronym': 'MARITIME-HF', 'briefTitle': 'Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)', 'orgStudyIdInfo': {'id': '20230227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maridebart Cafraglutide', 'description': 'Participants will receive maridebart cafraglutide subcutaneously (SC)', 'interventionNames': ['Drug: Maridebart cafraglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo SC', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Maridebart cafraglutide', 'type': 'DRUG', 'otherNames': ['AMG 133', 'MariTide'], 'description': 'Maridebart cafraglutide will be administered SC.', 'armGroupLabels': ['Maridebart Cafraglutide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered SC.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SEC Clinical Research', 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'facility': 'Yuma Clinical Trials', 'geoPoint': {'lat': 32.72532, 'lon': -114.6244}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Arkansas Cardiology', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'National Heart Institute', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91726', 'city': 'Covina', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Valley Clinical Trials, LLC dba Flourish Research', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'National Institute of Clinical Research', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': '310 Clinical Research', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Radin Cardiovascular Medical Group', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Valley Clinical Trials', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Empire Clinical Research', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'San Diego Cardiac Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NorthBay Clinical Research LLC', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '95204', 'city': 'Stockton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Manshadi Heart Institute', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cardiology Associates of Fairfield County PC', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '32714', 'city': 'Altamonte Springs', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orlando Heart and Vascular Institute', 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'facility': 'Encore Medical Research LLC', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Nature Coast Clinical Research', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'East Coast Institute for Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'First Coast Cardiovascular Institute PA', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33777', 'city': 'Largo', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clearwater Cardiovascular Consultants', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ocala Cardiovascular Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orlando Health Heart Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ormond Beach Clinical Research', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Broward Research Center', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cardiovascular Center of Sarasota', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33449', 'city': 'Wellington', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cardiology Partners Clinical Research Institute', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '32792', 'city': 'Winter Park', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Guardian Research Organization LLC', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30269', 'city': 'Peachtree City', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Privia Medical Group Georgia LLC', 'geoPoint': {'lat': 33.39678, 'lon': -84.59576}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'High Desert Heart and Vascular', 'geoPoint': 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There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}