[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561077":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":40,"locations":46,"responsibleParty":142,"collaborators":25,"id":144,"slug":25,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":25,"eligibilityCriteria":149,"healthyVolunteers":150,"sex":151,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":25,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"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",[47,60,69,78,88,97,106,112,122,132],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":25},"Anaheim Clinical Trials","RECRUITING","Anaheim","California","92801","United States",{"type":55,"coordinates":56},"Point",[57,58],-117.9145,33.83529,{"lat":58,"lon":57},{"facility":61,"status":49,"city":62,"state":51,"zip":63,"country":53,"cosmosGeoPoint":64,"geoPoint":68,"contacts":25},"Orange County Research Center","Lake Forest","92630",{"type":55,"coordinates":65},[66,67],-117.68922,33.64697,{"lat":67,"lon":66},{"facility":70,"status":49,"city":71,"state":51,"zip":72,"country":53,"cosmosGeoPoint":73,"geoPoint":77,"contacts":25},"Fomat Medical Research","Oxnard","93030",{"type":55,"coordinates":74},[75,76],-119.17705,34.1975,{"lat":76,"lon":75},{"facility":79,"status":49,"city":80,"state":81,"zip":82,"country":53,"cosmosGeoPoint":83,"geoPoint":87,"contacts":25},"Translational Clinical Research LLC","Aventura","Florida","33180",{"type":55,"coordinates":84},[85,86],-80.13921,25.95648,{"lat":86,"lon":85},{"facility":89,"status":49,"city":90,"state":81,"zip":91,"country":53,"cosmosGeoPoint":92,"geoPoint":96,"contacts":25},"Clinical Neuroscience Solutions - Jacksonville","Jacksonville","32256",{"type":55,"coordinates":93},[94,95],-81.65565,30.33218,{"lat":95,"lon":94},{"facility":98,"status":49,"city":99,"state":81,"zip":100,"country":53,"cosmosGeoPoint":101,"geoPoint":105,"contacts":25},"New Horizon Research Center","Miami","33165",{"type":55,"coordinates":102},[103,104],-80.19366,25.77427,{"lat":104,"lon":103},{"facility":107,"status":49,"city":99,"state":81,"zip":108,"country":53,"cosmosGeoPoint":109,"geoPoint":111,"contacts":25},"Clinical Pharmacology of Miami, LLC","33172",{"type":55,"coordinates":110},[103,104],{"lat":104,"lon":103},{"facility":113,"status":49,"city":114,"state":115,"zip":116,"country":53,"cosmosGeoPoint":117,"geoPoint":121,"contacts":25},"Rophe Adult and Pediatric Medicine\u002FSky Clinical Research Network Group","Union City","Georgia","30291",{"type":55,"coordinates":118},[119,120],-84.54243,33.58706,{"lat":120,"lon":119},{"facility":123,"status":49,"city":124,"state":125,"zip":126,"country":53,"cosmosGeoPoint":127,"geoPoint":131,"contacts":25},"Lillestol Research LLC","Fargo","North Dakota","58104",{"type":55,"coordinates":128},[129,130],-96.7898,46.87719,{"lat":130,"lon":129},{"facility":133,"status":49,"city":134,"state":135,"zip":136,"country":53,"cosmosGeoPoint":137,"geoPoint":141,"contacts":25},"Pinnacle Clinical Research","Austin","Texas","78757",{"type":55,"coordinates":138},[139,140],-97.74306,30.26715,{"lat":140,"lon":139},{"type":143,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":155,"type":156},80,"ESTIMATED","INTERVENTIONAL",[159],"PHASE1","The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.",[162],"Cardiometabolic Disease",[22,164],"Cardiometabolic disease","2026-06-18",{"date":167,"type":168},"2026-06-22","ACTUAL",{"date":170,"type":168},"2024-09-09",{"date":172,"type":156},"2026-10-01",{"name":5,"class":6},10]