[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659564":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":11,"studyPopulation":11,"armGroups":48,"interventions":61,"overallOfficials":71,"centralContacts":75,"locations":11,"responsibleParty":81,"collaborators":11,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":11,"enrollmentInfo":93,"targetDuration":11,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":109,"whyStopped":11,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":11},{"fullName":5,"class":6},"Amgen","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]",null,"Baseline to Week 68",[14,16,18,21,23,25,27,29,31,33,35,38,40],{"measure":15,"description":11,"timeFrame":12},"Change from Baseline in HbA1c at week 68 [Superiority]",{"measure":17,"description":11,"timeFrame":12},"Percent Change from Baseline in Body Weight at Week 68",{"measure":19,"description":11,"timeFrame":20},"Percentage of Participants Achieving HbA1c \u003C 7.0% at Week 68","Week 68",{"measure":22,"description":11,"timeFrame":20},"Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68",{"measure":24,"description":11,"timeFrame":20},"Percentage of Participants Achieving HbA1c \u003C 5.7% at Week 68",{"measure":26,"description":11,"timeFrame":12},"Change from Baseline in Fasting Plasma Glucose at Week 68",{"measure":28,"description":11,"timeFrame":12},"Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68",{"measure":30,"description":11,"timeFrame":12},"Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68",{"measure":32,"description":11,"timeFrame":12},"Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68",{"measure":34,"description":11,"timeFrame":12},"Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68",{"measure":36,"description":11,"timeFrame":37},"Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","Up To 81 Weeks",{"measure":39,"description":11,"timeFrame":37},"Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes",{"measure":41,"description":11,"timeFrame":20},"Plasma Concentration of Maridebart Cafraglutide at Week 68",{"allocation":43,"interventionModel":44,"interventionModelDescription":11,"primaryPurpose":45,"observationalModel":11,"timePerspective":11,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":11,"whoMasked":11},"NONE",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Maridebart cafraglutide","EXPERIMENTAL","Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner.",[54],"Drug: Maridebart cafraglutide",{"label":56,"type":57,"description":58,"interventionNames":59},"Semaglutide","ACTIVE_COMPARATOR","Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner.",[60],"Drug: Semaglutide",[62,69],{"type":63,"name":50,"description":64,"armGroupLabels":65,"otherNames":66},"DRUG","Administered subcutaneously.",[50],[67,68],"AMG 133","MariTide",{"type":63,"name":56,"description":64,"armGroupLabels":70,"otherNames":11},[56],[72],{"name":73,"affiliation":5,"role":74},"MD","STUDY_DIRECTOR",[76],{"name":77,"role":78,"phone":79,"phoneExt":11,"email":80},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",{"type":82,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659564","phase-3-maridebart-cafraglutide-versus-semaglutide-in-participants-with-type-2-diabetes-100659564",false,"NCT07866066","Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes","A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes","MARITIME-T2D-3","Inclusion Criteria:\n\n* HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol\u002Fmol)) and ≤ 10.5% (91.0 mmol\u002Fmol) at screening.\n* Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg\u002Fday), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization.\n* Body mass index (BMI) ≥ 25 kilograms per meter squared (kg\u002Fm\\^2) at screening.\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state\u002Fcoma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.\n* Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and\u002For macular edema.\n* Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.\n* One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.\n* History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.\n* Self-reported change in body weight \\> 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and\u002For dietary measures for diabetes treatment.\n* Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:\n\n  * liposuction and\u002For abdominoplasty that was performed \\> 1 year before screening.\n  * laparoscopic adjustable gastric banding, intragastric balloon, and\u002For duodenal-jejunal bypass liner or gastric sleeve if removed \\> 1 year before screening.","ALL","18 Years",{"count":94,"type":95},1300,"ESTIMATED","INTERVENTIONAL",[98],"PHASE3","The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.",[101],"Diabetes Mellitus, Type 2",[103,104,56,68,105,106,107,108],"Add-on to Metformin","Maridebart Cafraglutide","A1C","Weight","Obesity","Overweight","NOT_YET_RECRUITING","2026-10-05",{"date":112,"type":113},"2026-10-08","ACTUAL",{"date":115,"type":95},"2026-11-02",{"date":117,"type":95},"2028-12-04",{"name":5,"class":6}]