Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-30 @ 4:33 PM
Study NCT ID:
NCT07037433
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2025-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-25', '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, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE])', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, MI, Ischemic Stroke, Coronary Revascularization, or Heart Failure (HF) Event (5-point MACE)', 'timeFrame': 'Up to approximately 35 months'}], 'secondaryOutcomes': [{'measure': 'Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or HF Event', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke or Coronary Revascularization', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First MI', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Ischemic Stroke', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to CV Death', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to All-cause Death', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Coronary Revascularization', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First HF Event', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First HF Event or CV Death', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Unstable Angina Requiring Hospitalization', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Occurrence of MI or CV Death', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Occurrence of MI, Ischemic Stroke or All-cause Death', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Total Major Ischemic Events (Time to First and Recurrent MI or Ischemic Stroke)', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Total All-cause Hospitalizations (Time to First and Recurrent Event)', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes at Baseline', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to Onset of T2DM in Participants without T2DM at Baseline', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Change from Baseline in Systolic Blood Pressure (SBP) at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in Diastolic Blood Pressure (DBP) at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in Body Mass Index (BMI) at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in Waist Circumference at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in Fasting Plasma Glucose at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in High-sensitivity C-reactive protein (hs-CRP) at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in Body Weight at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in Total Cholesterol at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percent Change from Baseline in Triglycerides (TG) at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants with T2DM at Baseline', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants with T2DM at Baseline', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with T2DM at Baseline', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants Without T2DM at Baseline', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants Without T2DM at Baseline', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants Without T2DM at Baseline', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with HbA1c ≥ 5.7% and < 6.5% at Baseline', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in Short Form 36 Health Survey Acute Version 2 (SF-36 v2) Physical Function Domain Score at Week 48', 'timeFrame': 'Baseline and Week 48'}, {'measure': 'Time to First Event of a Composite Nephropathy Endpoint', 'timeFrame': 'Up to approximately 35 months', 'description': 'Composite endpoint consists of onset of persistent macroalbuminuria, persistent ≥ 40% reduction in estimated glomerular filtration rate (eGFR), onset of persistent eGFR \\< 15 mL/min/1.73 m2, initiation of chronic renal replacement therapy (dialysis or transplantation), CV or renal death.'}, {'measure': 'Change in eGFR (total slope) for the period from baseline to the final follow up visit', 'timeFrame': 'Baseline up to approximately 35 months'}, {'measure': 'Change in eGFR (chronic slope) for the period from 4 months to the final follow-up visit', 'timeFrame': 'From 4 months up to approximately 35 months'}, {'measure': 'Time to First Occurrence of a Major Adverse Limb Event (MALE) Defined as Acute Limb Ischemia, Urgent Peripheral Revascularization, Major Amputation Due to a Vascular Etiology or Chronic Limb-threatening Ischemia Requiring Revascularization', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Total Arterial (Coronary, Cerebrovascular, and Peripheral) Revascularization Procedures (Time to First and Recurrent Event)', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, MALE, or Arterial Revascularization', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or Acute Limb Ischemia', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Time to First Occurrence of a Composite Endpoint Consisting of CV Death, MI, Ischemic Stroke, Acute Limb Ischemia, or Urgent Arterial Revascularization Procedure (Coronary, Cerebrovascular or Peripheral)', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Number of Participants with Treatment-emergent Adverse Events', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Number of Participants with Serious Adverse Events', 'timeFrame': 'Up to approximately 35 months'}, {'measure': 'Plasma Concentration of Maridebart Cafraglutide at Week 72', 'timeFrame': 'Week 72'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atherosclerotic Cardiovascular Disease', 'Overweight', 'Obesity', 'Maridebart cafraglutide', 'AMG 133', 'MariTide'], 'conditions': ['Atherosclerotic Cardiovascular Disease', 'Overweight', 'Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age ≥ 45 years at screening.\n* BMI of ≥ 27 kg/m2 at screening.\n* History of Atherosclerotic Cardiovascular Disease (ASCVD) as evidenced by at least one of the following:\n\n * Prior MI.\n * Prior ischemic stroke (may include ischemic stroke with hemorrhagic transformation).\n * Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) \\< 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.\n\nExclusion Criteria\n\n* History of any of the following within 60 days before screening: MI, hospitalization for unstable angina, coronary artery revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke, or transient ischemic attack (TIA).\n* New York Heart Association (NYHA) class IV HF at screening or hospitalization for HF within 60 days before screening.\n* Type 1 DM, 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 * HbA1c \\> 10.0% (86 mmol/mol) at screening.\n * History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before screening.\n * One or more episodes of severe hypoglycemia within 6 months before screening and/or history of hypoglycemia unawareness.\n * History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.\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.\n* History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening.\n* Family (first-degree relative\\[s\\]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2).\n* Calcitonin ≥ 50 ng/L (pg/mL) at screening.\n* Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) \\> 3.0 x the upper limit of normal (ULN), or total bilirubin (TBL) \\> 1.8 x ULN (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL).\n* History of malignancy within the last 5 years before screening (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ).\n* Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.'}, 'identificationModule': {'nctId': 'NCT07037433', 'acronym': 'MARITIME-CV', 'briefTitle': 'Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity', 'orgStudyIdInfo': {'id': '20220196'}}, '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': '36526', 'city': 'Daphne', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Alliance For Multispecialty Research - Daphne', 'geoPoint': {'lat': 30.60353, 'lon': -87.9036}}, {'zip': '36532', 'city': 'Fairhope', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Eastern Shore Research Institute', 'geoPoint': {'lat': 30.52297, 'lon': -87.90333}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Heart Center Research LLC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mobile Heart Specialists PC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Syed Research Consultants LLC', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Synexus Clinical Research US, Inc.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85044', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medical Advancement Centers of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91726', 'city': 'Covina', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 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'RECRUITING', 'country': 'United Kingdom', 'facility': 'Wycombe Hospital', 'geoPoint': {'lat': 51.62907, 'lon': -0.74934}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'EC1M 6BQ', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Queen Mary University of London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE1 4LP', 'city': 'Newcastle', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Newcastle NIHR Commercial Research Delivery Centre', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'SA2 8PP', 'city': 'Swansea', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Morriston Hospital', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'BA15 1DQ', 'city': 'Wiltshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Bradford on Avon and Melksham Health Partnership'}, {'zip': 'WR5 1DD', 'city': 'Worcester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Worcestershire Royal Hospital', 'geoPoint': {'lat': 52.18935, 'lon': -2.22001}}], 'centralContacts': [{'name': 'Amgen Call Center', 'role': 'CONTACT', 'email': 'medinfo@amgen.com', 'phone': '866-572-6436'}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'https://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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'}}}}