[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660050":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":11,"studyPopulation":11,"armGroups":34,"interventions":42,"overallOfficials":55,"centralContacts":59,"locations":65,"responsibleParty":79,"collaborators":11,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":103,"whyStopped":11,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Amgen","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration",null,"Weeks 12, 16, and 20",{"measure":14,"description":11,"timeFrame":12},"Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration",[16,19,22,25],{"measure":17,"description":11,"timeFrame":18},"Number of Participants Who Experience Device-related Adverse Events","Up To 37 weeks",{"measure":20,"description":11,"timeFrame":21},"Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","TEAEs: From baseline (Day 1) up to end of trial (approximately 37 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 41 weeks).",{"measure":23,"description":11,"timeFrame":24},"Plasma Concentration of Maridebart Cafraglutide at Week 24","Week 24",{"measure":26,"description":11,"timeFrame":27},"Percent Change From Baseline in Body Weight at Week 24","Baseline and Week 24",{"allocation":29,"interventionModel":30,"interventionModelDescription":11,"primaryPurpose":31,"observationalModel":11,"timePerspective":11,"maskingInfo":32},"NA","SINGLE_GROUP","TREATMENT",{"masking":33,"maskingDescription":11,"whoMasked":11},"NONE",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"Maridebart cafraglutide","EXPERIMENTAL","Participants will receive 8 total doses of subcutaneous (SC) injections of maridebart cafraglutide.",[40,41],"Drug: Maridebart cafraglutide","Device: Autoinjector",[43,50],{"type":44,"name":36,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","Administered subcutaneously.",[36],[48,49],"AMG 133","MariTide",{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":11},"DEVICE","Autoinjector","The AI will be used by participants to self-administer SC doses of maridebart cafraglutide.",[36],[56],{"name":57,"affiliation":5,"role":58},"MD","STUDY_DIRECTOR",[60],{"name":61,"role":62,"phone":63,"phoneExt":11,"email":64},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",[66],{"facility":67,"status":11,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":11},"Charter Research - The Villages","The Villages","Florida","32162","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-81.95994,28.93408,{"lat":77,"lon":76},{"type":80,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100660050","phase-3-home-self-administration-of-maridebart-cafraglutide-with-autoinjector-in-adults-living-with-obesity-or-overweight-100660050",false,"NCT07871409","Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight","A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus","MARITIME-PEN","Inclusion Criteria:\n\n* Body mass index (BMI) ≥ 30 kilograms per meter square (kg\u002Fm\\^2), or BMI ≥ 27 to \\\u003C 30 kg\u002Fm\\^2 with one of the following:\n\n  * hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg\n  * dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol.\n  * history of obstructive sleep apnea\n  * history of cardiovascular disease\n  * history of fatty liver disease (including metabolic dysfunction-associated steatotic liver disease \\[MASLD\\] or metabolic dysfunction-associated steatohepatitis \\[MASH\\])\n* At least 1 unsuccessful attempt at weight loss by diet and exercise.\n* Contraception for females.\n* Willingness to follow trial procedures for the duration of the trial.\n\nExclusion Criteria:\n\n* Obesity induced by other endocrinologic disorders.\n* Change in body weight \\> 5 kg within last 90 days.\n* Previous or planned surgical, endoscopic, or device-based treatment for obesity.\n* History of malignancy within the past 5 years.\n* Type 1 or Type 2 diabetes mellitus.\n* History of chronic pancreatitis or history of acute pancreatitis within last 180 days.\n* Family or personal history of medullary thyroid cancer.\n* Previous participation in a Maridebart Cafraglutide trial.","ALL","18 Years","99 Years",{"count":93,"type":94},230,"ESTIMATED","INTERVENTIONAL",[97],"PHASE3","The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.",[100,101],"Obesity","Overweight",[48],"NOT_YET_RECRUITING","2026-10-07",{"date":106,"type":107},"2026-10-13","ACTUAL",{"date":109,"type":94},"2026-10-28",{"date":111,"type":94},"2027-09-08",{"name":5,"class":6},1]