[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599922":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":34,"interventions":62,"overallOfficials":74,"centralContacts":78,"locations":87,"responsibleParty":174,"collaborators":23,"id":176,"slug":177,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":23,"eligibilityCriteria":182,"healthyVolunteers":183,"sex":184,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":23,"studyType":190,"phases":191,"briefSummary":193,"conditions":194,"keywords":23,"overallStatus":115,"whyStopped":23,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"Eli Lilly and Company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module","Baseline up to Approximately Day 190",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044","PK: Cmax of LY4088044",{"measure":18,"description":19,"timeFrame":12},"PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044","PK: AUC of LY4088044",{"measure":21,"description":22,"timeFrame":12},"Pharmacodynamics (PD): Protein Levels in Skin Samples","PD: Percent Decrease in Protein Levels",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":29,"maskingDescription":30,"whoMasked":31},"DOUBLE","Sponsor is blinded",[32,33],"PARTICIPANT","INVESTIGATOR",[35,41,47,51,55,59],{"label":36,"type":37,"description":38,"interventionNames":39},"LY4088044 (Part A)","EXPERIMENTAL","Single-ascending dose (SAD) of LY4088044 administered intravenously (IV)",[40],"Drug: LY4088044",{"label":42,"type":43,"description":44,"interventionNames":45},"Placebo (Part A)","PLACEBO_COMPARATOR","Administered IV",[46],"Drug: Placebo",{"label":48,"type":37,"description":49,"interventionNames":50},"LY4088044 (Part B)","SAD of LY4088044 administered subcutaneously (SC)",[40],{"label":52,"type":43,"description":53,"interventionNames":54},"Placebo (Part B)","Administered SC",[46],{"label":56,"type":37,"description":57,"interventionNames":58},"LY4088044 (Part C)","Multiple-ascending doses (MAD) of LY4088044 administered IV",[40],{"label":60,"type":43,"description":44,"interventionNames":61},"Placebo (Part C)",[46],[63,67,69,72],{"type":64,"name":65,"description":44,"armGroupLabels":66,"otherNames":23},"DRUG","LY4088044",[36,56],{"type":64,"name":65,"description":53,"armGroupLabels":68,"otherNames":23},[48],{"type":64,"name":70,"description":44,"armGroupLabels":71,"otherNames":23},"Placebo",[42,60],{"type":64,"name":70,"description":53,"armGroupLabels":73,"otherNames":23},[52],[75],{"name":76,"affiliation":5,"role":77},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",[79,84],{"name":80,"role":81,"phone":82,"phoneExt":23,"email":83},"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","CONTACT","1-317-615-4559","LillyTrials@Lilly.com",{"name":85,"role":81,"phone":23,"phoneExt":23,"email":86},"Physicians interested in becoming principal investigators please contact","clinical_inquiry_hub@lilly.com",[88,102,113,130,144,159],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":23},"Collaborative Neuroscience Network - CNS","ACTIVE_NOT_RECRUITING","Los Alamitos","California","90720","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-118.07256,33.80307,{"lat":100,"lon":99},{"facility":103,"status":104,"city":105,"state":106,"zip":107,"country":94,"countryCode":95,"cosmosGeoPoint":108,"geoPoint":112,"contacts":23},"ICON","SUSPENDED","Lenexa","Kansas","66219",{"type":97,"coordinates":109},[110,111],-94.73357,38.95362,{"lat":111,"lon":110},{"facility":114,"status":115,"city":116,"state":117,"zip":118,"country":94,"countryCode":95,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"ICON Early Phase Services","RECRUITING","San Antonio","Texas","78232",{"type":97,"coordinates":120},[121,122],-98.49363,29.42412,{"lat":122,"lon":121},[125,127],{"name":23,"role":81,"phone":126,"phoneExt":23,"email":23},"210-283-4156",{"name":128,"role":129,"phone":23,"phoneExt":23,"email":23},"Chinonye Ogbonnaya-Odor","PRINCIPAL_INVESTIGATOR",{"facility":103,"status":115,"city":131,"state":132,"zip":133,"country":94,"countryCode":95,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Salt Lake City","Utah","84124",{"type":97,"coordinates":135},[136,137],-111.89105,40.76078,{"lat":137,"lon":136},[140,142],{"name":23,"role":81,"phone":141,"phoneExt":23,"email":23},"801-269-8200",{"name":143,"role":129,"phone":23,"phoneExt":23,"email":23},"Ahad Sabet",{"facility":145,"status":146,"city":147,"state":23,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"New Zealand Clinical Research Christchurch","NOT_YET_RECRUITING","Christchurch","8011","New Zealand","NZ",{"type":97,"coordinates":152},[153,154],172.63333,-43.53333,{"lat":154,"lon":153},[157],{"name":158,"role":129,"phone":23,"phoneExt":23,"email":23},"Chris Wynne",{"facility":160,"status":115,"city":161,"state":23,"zip":162,"country":161,"countryCode":163,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Lilly Centre for Clinical Pharmacology","Singapore","138623","SG",{"type":97,"coordinates":165},[166,167],103.85007,1.28967,{"lat":167,"lon":166},[170,172],{"name":23,"role":81,"phone":171,"phoneExt":23,"email":23},"+65 6413 9811",{"name":173,"role":129,"phone":23,"phoneExt":23,"email":23},"Jeffer Hann Wei Pang",{"type":175,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100599922","phase-1-a-study-of-ly4088044-in-healthy-participants-100599922",false,"NCT07090785","A Study of LY4088044 in Healthy Participants","A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4088044 in Healthy Participants.","Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring\n* Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg\u002Fm²)\n\nExclusion Criteria:\n\n* Are individuals assigned female at birth (AFAB) who are pregnant and\u002For lactating\n* Regularly use known drugs of abuse or show positive findings on urinary drug screening that are not consistent with their medication history\n* Participants with hemoglobin outside of the local laboratory normal range for age and gender, or evidence of iron deficiency, or hemoglobinopathy\n* Participants with estimated glomerular filtration rate (GFR) less than 90 milliliter per minute per 1.73 square meter (mL\u002Fmin\u002F1.73 m²)\n* Have a 12-lead electrocardiogram (ECG) abnormality\n* Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes AND are unable to abide by investigative site smoking restrictions\n* Have an average weekly alcohol intake that exceeds 21 units per week (males less than or equal to 65 years old) and 14 units per week (females and males over 65-year-old, if applicable) and are unwilling to abide by the restrictions",true,"ALL","18 Years","65 Years",{"count":188,"type":189},104,"ESTIMATED","INTERVENTIONAL",[192],"PHASE1","The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it.\n\nThe study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.",[195],"Healthy","2026-10-06",{"date":198,"type":199},"2026-10-07","ACTUAL",{"date":201,"type":199},"2025-07-24",{"date":203,"type":189},"2027-07",{"name":5,"class":6},6]