[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640678":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":73,"collaborators":34,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":34,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":34,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":51,"whyStopped":34,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Amgen","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Single Ascending Dose (SAD)","EXPERIMENTAL","Participants will receive single ascending doses of AMG 127 via subcutaneous (SC) injection. One cohort will receive a single dose of AMG 127 as an intravenous (IV) infusion.",[13],"Drug: AMG 127",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B: Multiple Ascending Dose (MAD)","Participants will receive multiple ascending doses of AMG 127 via SC injection.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part C: Proof of Mechanism (PoM)","Participants will receive multiple doses of AMG 127 via SC injection.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Placebo","PLACEBO_COMPARATOR","Participants will receive a matching placebo as either a SC injection or as an IV infusion.",[27],"Drug: Placebo",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","AMG 127","AMG127 will be administered as either a SC injection or as an IV infusion.",[9,15,19],null,{"type":30,"name":23,"description":36,"armGroupLabels":37,"otherNames":34},"Placebo will be administered as either a SC injection or as an IV infusion.",[23],[39],{"name":40,"affiliation":5,"role":41},"MD","STUDY_DIRECTOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":34,"email":47},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",[49,63],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":34},"Orange County Research Center","RECRUITING","Lake Forest","California","92630","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-117.68922,33.64697,{"lat":61,"lon":60},{"facility":64,"status":51,"city":65,"state":66,"zip":67,"country":55,"countryCode":56,"cosmosGeoPoint":68,"geoPoint":72,"contacts":34},"Translational Clinical Research LLC","Aventura","Florida","33180",{"type":58,"coordinates":69},[70,71],-80.13921,25.95648,{"lat":71,"lon":70},{"type":74,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100640678","phase-1-a-trial-evaluating-amg-127-in-healthy-participants-and-participants-with-type-2-diabetes-mellitus-100640678",false,"NCT07590193","A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus","A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus","Inclusion Criteria for Part A and B\n\n* Participant must be 18-65 years of age\n* Participant must be overtly healthy\n\nInclusion Criteria for Part C\n\n* Participant must be 40-75 years of age\n* Confirmed diagnoses of T2DM\n\nExclusion Criteria for Part A and B\n\n* History of hypotension, syncope, or orthostatic intolerance\n* Systolic blood pressure \\>140 millimeters of mercury (mmHg) or diastolic blood pressure \\>90 mmHg\n\nExclusion Criteria for Part C\n\n* Hemoglobin A1c (HbA1c) \\>10% within the last 3 months\n* History of hypotension, syncope, or orthostatic intolerance\n* Systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg",true,"ALL","18 Years","75 Years",{"count":87,"type":88},162,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).",[94],"Diabetes Mellitus, Type 2",[31,96,97],"healthy participants","type 2 diabetes mellitus","2026-07-31",{"date":100,"type":101},"2026-08-03","ACTUAL",{"date":103,"type":101},"2026-06-11",{"date":105,"type":88},"2027-10-02",{"name":5,"class":6},2]