[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609823":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":53,"collaborators":11,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":11,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Hanmi Pharmaceutical Company Limited","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HM17321","EXPERIMENTAL",null,[13],"Drug: HM17321",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo of HM17321",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Participants will receive a single or multiple subcutaneous injections of HM17321 at the assigned dose level. HM17321 is provided as a sterile solution in prefilled syringes.",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Placebo of HM17321","Participants will receive a single or multiple subcutaneous injections of a matching placebo solution in prefilled syringes. The placebo does not contain any active ingredients.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Jimin Han","CONTACT","+82-2-410-9838","jimin.han@hanmi.co.kr",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Medpace Clinical Pharmacology Unit","RECRUITING","Cincinnati","Ohio","45227","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-84.51439,39.12711,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":11,"phoneExt":11,"email":11},"Leela Vrishabhendra","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100609823","phase-1-a-single-and-multiple-ascending-dose-study-of-hm17321-in-healthy-and-obese-participants-100609823",false,"NCT07219589","A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants","A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM17321 in Healthy and Obese Participants","Inclusion Criteria:\n\n* Adults aged 18-65 years.\n* Part A: Healthy participants with BMI ≥20 kg\u002Fm² and ≤27 kg\u002Fm² at screening.\n* Part B: Healthy obese participants with BMI ≥30 kg\u002Fm² and ≤45 kg\u002Fm² at screening.\n* Stable body weight (\\\u003C5% change) in the past 3 months.\n* Able and willing to provide written informed consent.\n* Male participants must use contraception or remain abstinent from women of childbearing potential.\n* Female participants must not be pregnant or breastfeeding and use highly effective contraception if of childbearing potential.\n\nExclusion Criteria:\n\n* History of any bariatric procedure.\n* Uncontrolled thyroid disease (TSH \\>6.0 or \\\u003C0.4 mIU\u002FL).\n* Abnormal liver function or clinically significant liver disease\n\n  * Part A: ALT or AST ≥ ULN, or total bilirubin ≥ ULN\n  * Part B: ALT or AST \\>2× ULN, or total bilirubin \\>1.5× ULN\n* Abnormal pancreatic function\n\n  * Part A: amylase or lipase ≥ ULN\n  * Part B: amylase or lipase \\>3× ULN\n* Clinically significant cardiovascular disorders (e.g., myocardial infarction, congestive heart failure, long QT syndrome).\n* Abnormal renal function (eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²).\n* Positive test for hepatitis B, hepatitis C, or HIV at screening.\n* Women who are pregnant, planning to become pregnant, or breastfeeding.\n* History of drug or alcohol abuse within defined timeframes (e.g., alcohol \\>14 standard units\u002Fweek in past year, or positive drug screen).\n* Use of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to screening.\n* Additional Exclusion Criteria for Part B\n\n  * HbA1c ≥6.5% or a history of diabetes mellitus (type 1 or type 2).\n  * Obesity induced by other endocrine disorders (e.g., Cushing syndrome).\n  * Use of weight control treatments (e.g., GLP-1 receptor agonists or other anti-obesity medications) and antihypertensive medications within 3 months prior to screening.\n  * Use of any lipid-lowering medications, unless on a stable dose for at least 3 months prior to screening.",true,"ALL","18 Years","65 Years",{"count":67,"type":68},90,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 after single and multiple ascending doses in healthy and obese participants.",[74,75],"Obesity","Obese",[75,74],"2026-04-28",{"date":79,"type":80},"2026-05-04","ACTUAL",{"date":82,"type":80},"2025-11-06",{"date":84,"type":68},"2027-03",{"name":5,"class":6},1]