[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648450":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":64,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Zealand Pharma","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug: ZP6590, solution for injection","ACTIVE_COMPARATOR","ZP6590 will be administered as single dose administration and as multiple dose administrations.",[9],{"label":14,"type":15,"description":16,"interventionNames":17},"Placebo, solution for injections","PLACEBO_COMPARATOR","Placebo will be administered as single dose administration and as multiple dose administrations.",[18],"Drug: Placebo, solution for injection",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ZP6590, solution for injection","Participants will receive single or multiple subcutaneous dose administrations of ZP6590.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo, solution for injection","Participants will receive single or multiple subcutaneous dose administrations of Placebo.",[14],[31],{"name":32,"affiliation":33,"role":34},"Ulrike Hövelmann","Profil Institut für Stoffwechselforschung GmbH","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Regulatory Affairs Department Regulatory Affairs Department, MDRA","CONTACT","+49213140180","clinicaltrialservices@profil.com",{"name":42,"role":38,"phone":39,"phoneExt":25,"email":40},"Regulatory Affairs Department Regulatory Affairs Department",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Profil, Institut für Stoffwechselforschung GmbH","RECRUITING","Neuss","North Rhine-Westphalia","41460","Germany","DE",{"type":53,"coordinates":54},"Point",[55,56],6.68504,51.19807,{"lat":56,"lon":55},[59,60,62],{"name":42,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":61,"role":38,"phone":39,"phoneExt":25,"email":40},"Project Management Project Management",{"name":63,"role":34,"phone":25,"phoneExt":25,"email":25},"Ulrike Hövelmann, MD",{"type":65,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100648450","early-phase-1-a-single-and-multiple-ascending-dose-trial-assessing-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-zp6590-in-participants-with-normal-weight-overweight-and-obesity-100648450",false,"NCT07721597","A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity","A First-in-human, Randomized, Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity","Inclusion Criteria:\n\nSAD-Part:\n\n* Male participant\n* Age between 18 and 55 years, both inclusive\n* Body Mass Index (BMI) between 20.0 and 29.9 kg\u002Fm\\^2, both inclusive\n\nMAD-Part:\n\n* Male participant\n* Age between 18 and 60 years, both inclusive\n* Body Mass Index (BMI) between 27.0 and 39.9 kg\u002Fm\\^2, both inclusive\n\nExclusion Criteria:\n\nSAD-Part and MAD-Part:\n\n* Any clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the investigator\n* Treatment for weight management within 3 months before randomization in this trial",true,"MALE","18 Years","60 Years",{"count":78,"type":79},88,"ESTIMATED","INTERVENTIONAL",[82],"EARLY_PHASE1","The goal of this clinical trial is to learn about the safety and tolerability of drug ZP6590 and to learn how the body processes the drug ZP6590 in adults. The main questions it aims to answer are:\n\n* Is the drug ZP6590 safe and well tolerated when administered as escalating single and multiple doses of the ZP6590?\n* How quickly and to what extent the administered investigational drug is absorbed and distributed, and how long it takes to be eliminated from the body?\n\nIn the first Part of the study:\n\nParticipants will:\n\n• Get a single ascending dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.\n\nIn the second Part of the study:\n\nParticipants will:\n\n• Get multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.",[85,86,87],"Healthy Participants Study","Overweight and Obese Adults","First in Man Study to Evaluate Initial Safety",[89,90,91,92],"ZP6590","Safety and Tolerability","GIP-R agonist","obesity","2026-08-12",{"date":95,"type":96},"2026-08-13","ACTUAL",{"date":98,"type":96},"2026-07-09",{"date":100,"type":79},"2027-09-06",{"name":5,"class":6},1]