[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561077":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":40,"locations":46,"responsibleParty":143,"collaborators":25,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":25,"eligibilityCriteria":151,"healthyVolunteers":152,"sex":153,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":25,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Amgen","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Ascending Dose (SAD) in Participants with Obesity (Part A)","EXPERIMENTAL","In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV).",[13,14],"Drug: AMG 513","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B)","In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC.",[13,14],[20,26,30,33],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AMG 513","AMG 513 will be administered by SC or IV injection.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Placebo will be administered by SC or IV injection.",[9],{"type":21,"name":22,"description":31,"armGroupLabels":32,"otherNames":25},"AMG 513 will be administered by SC injection.",[16],{"type":21,"name":27,"description":34,"armGroupLabels":35,"otherNames":25},"Placebo will be administered by SC injection.",[16],[37],{"name":38,"affiliation":5,"role":39},"MD","STUDY_DIRECTOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":25,"email":45},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",[47,61,70,79,89,98,107,113,123,133],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":25},"Anaheim Clinical Trials","RECRUITING","Anaheim","California","92801","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-117.9145,33.83529,{"lat":59,"lon":58},{"facility":62,"status":49,"city":63,"state":51,"zip":64,"country":53,"countryCode":54,"cosmosGeoPoint":65,"geoPoint":69,"contacts":25},"Orange County Research Center","Lake Forest","92630",{"type":56,"coordinates":66},[67,68],-117.68922,33.64697,{"lat":68,"lon":67},{"facility":71,"status":49,"city":72,"state":51,"zip":73,"country":53,"countryCode":54,"cosmosGeoPoint":74,"geoPoint":78,"contacts":25},"Fomat Medical Research","Oxnard","93030",{"type":56,"coordinates":75},[76,77],-119.17705,34.1975,{"lat":77,"lon":76},{"facility":80,"status":49,"city":81,"state":82,"zip":83,"country":53,"countryCode":54,"cosmosGeoPoint":84,"geoPoint":88,"contacts":25},"Translational Clinical Research LLC","Aventura","Florida","33180",{"type":56,"coordinates":85},[86,87],-80.13921,25.95648,{"lat":87,"lon":86},{"facility":90,"status":49,"city":91,"state":82,"zip":92,"country":53,"countryCode":54,"cosmosGeoPoint":93,"geoPoint":97,"contacts":25},"Clinical Neuroscience Solutions - Jacksonville","Jacksonville","32256",{"type":56,"coordinates":94},[95,96],-81.65565,30.33218,{"lat":96,"lon":95},{"facility":99,"status":49,"city":100,"state":82,"zip":101,"country":53,"countryCode":54,"cosmosGeoPoint":102,"geoPoint":106,"contacts":25},"New Horizon Research Center","Miami","33165",{"type":56,"coordinates":103},[104,105],-80.19366,25.77427,{"lat":105,"lon":104},{"facility":108,"status":49,"city":100,"state":82,"zip":109,"country":53,"countryCode":54,"cosmosGeoPoint":110,"geoPoint":112,"contacts":25},"Clinical Pharmacology of Miami, LLC","33172",{"type":56,"coordinates":111},[104,105],{"lat":105,"lon":104},{"facility":114,"status":49,"city":115,"state":116,"zip":117,"country":53,"countryCode":54,"cosmosGeoPoint":118,"geoPoint":122,"contacts":25},"Rophe Adult and Pediatric Medicine\u002FSky Clinical Research Network Group","Union City","Georgia","30291",{"type":56,"coordinates":119},[120,121],-84.54243,33.58706,{"lat":121,"lon":120},{"facility":124,"status":49,"city":125,"state":126,"zip":127,"country":53,"countryCode":54,"cosmosGeoPoint":128,"geoPoint":132,"contacts":25},"Lillestol Research LLC","Fargo","North Dakota","58104",{"type":56,"coordinates":129},[130,131],-96.7898,46.87719,{"lat":131,"lon":130},{"facility":134,"status":49,"city":135,"state":136,"zip":137,"country":53,"countryCode":54,"cosmosGeoPoint":138,"geoPoint":142,"contacts":25},"Pinnacle Clinical Research","Austin","Texas","78757",{"type":56,"coordinates":139},[140,141],-97.74306,30.26715,{"lat":141,"lon":140},{"type":144,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100561077","phase-1-single-and-multiple-ascending-dose-study-of-amg-513-in-participants-with-obesity-100561077",false,"NCT06585462","Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity","Inclusion Criteria:\n\n* Participants in the study will be males and females 18 to 65 years of age at the time of signing the informed consent with a body mass index (BMI) of 30.0 kg\u002Fm\\^2 to 40.0 kg\u002Fm\\^2 for Part A and BMI of 27.0 kg\u002Fm\\^2 to 40.0 kg\u002Fm\\^2 for Part B.\n* Females enrolled must be of non-childbearing potential.\n\nExclusion Criteria:\n\n* History and\u002For clinical evidence of diabetes mellitus, including hemoglobin A1c ≥ 6.5% and\u002For a fasting glucose of ≥ 126 mg\u002FdL (7 mmol\u002FL) at screening.\n* Triglycerides ≥ 5.65 mmol\u002FL (i.e., 500 mg\u002FdL) at screening.",true,"ALL","18 Years","65 Years",{"count":157,"type":158},80,"ESTIMATED","INTERVENTIONAL",[161],"PHASE1","The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.",[164],"Cardiometabolic Disease",[22,166],"Cardiometabolic disease","2026-06-18",{"date":169,"type":170},"2026-06-22","ACTUAL",{"date":172,"type":170},"2024-09-09",{"date":174,"type":158},"2026-10-01",{"name":5,"class":6},10]