[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657017":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":11,"studyPopulation":11,"armGroups":28,"interventions":40,"overallOfficials":49,"centralContacts":53,"locations":11,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":81,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":11},{"fullName":5,"class":6},"Amgen","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide",null,"Up to Day 120",{"measure":14,"description":11,"timeFrame":12},"Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide",{"measure":16,"description":11,"timeFrame":12},"Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide",[18,20],{"measure":19,"description":11,"timeFrame":12},"Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events",{"measure":21,"description":11,"timeFrame":12},"Number of Participants With Anti-Maridebart Cafraglutide Antibodies",{"allocation":23,"interventionModel":24,"interventionModelDescription":11,"primaryPurpose":25,"observationalModel":11,"timePerspective":11,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":11,"whoMasked":11},"NONE",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"Maridebart Cafraglutide (Test)","EXPERIMENTAL","Participants will receive maridebart cafraglutide (test formulation) via subcutaneous (SC) injection.",[34],"Drug: Maridebart Cafraglutide",{"label":36,"type":37,"description":38,"interventionNames":39},"Maridebart Cafraglutide (Reference)","ACTIVE_COMPARATOR","Participants will receive maridebart cafraglutide (reference formulation) via SC injection.",[34],[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Maridebart Cafraglutide","Maridebart cafraglutide will be administered via SC injection.",[36,30],[47,48],"AMG 133","MariTide",[50],{"name":51,"affiliation":5,"role":52},"MD","STUDY_DIRECTOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":11,"email":58},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657017","phase-1-comparing-the-extent-to-which-two-maridebart-cafraglutide-drug-products-are-made-available-in-the-body-after-a-single-subcutaneous-dose-100657017",false,"NCT07832799","Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose","A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Maridebart Cafraglutide (AMG 133) Drug Products in Participants Living With Overweight or Obesity","Inclusion Criteria:\n\n* Male or female participants, of any race, between 18 and 60 years of age (inclusive).\n* Females must not be pregnant or lactating.\n* Body mass index of ≥ 25.0 to \\\u003C 40.0 kilograms per square meter (kg\u002Fm\\^2).\n* Have a stable body weight within 3 months before screening.\n\nExclusion Criteria:\n\n* History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.\n* History of or active diabetes (regardless of type, except history of gestational diabetes), or hemoglobin A1c ≥ 6.5%.\n* History or evidence of endocrine disorder that can cause obesity.\n* History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase or amylase (\\> 2 x upper limit of normal \\[ULN\\]) at screening or check-in, or fasting serum triglyceride level of \\> 500 milligrams per deciliter (mg\u002FdL) at screening.\n* Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ treated with curative intent, within the last 5 years.\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2.\n* History or current signs or symptoms of cardiovascular disease.\n* History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related\u002Fsimilar compounds or its ingredients.\n* Estimated glomerular filtration rate ≤ 60 mL\u002Fmin\u002F1.73 m\\^2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (2021) at screening or check-in.\n* Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.\n* Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in.\n* Current or prior use of all herbal medicines, vitamins, and supplements consumed by the participant within the 30 days prior to check-in.\n* Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives, whichever is longer, prior to check-in.\n* Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received maridebart cafraglutide.","ALL","18 Years","60 Years",{"count":72,"type":73},340,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two maridebart cafraglutide drug products in participants living with overweight or obesity.",[79,80],"Overweight","Obesity","NOT_YET_RECRUITING","2026-09-16",{"date":84,"type":85},"2026-09-22","ACTUAL",{"date":87,"type":73},"2026-10-12",{"date":89,"type":73},"2027-03-23",{"name":5,"class":6}]