[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584593":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Novo Nordisk A\u002FS","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: NNC0581-0001 (Dose 1)","EXPERIMENTAL","Participants will receive a subcutaneous (s.c) injection of either NNC0581-0001 Dose 1 or a matching placebo once monthly.",[13,14],"Drug: NNC0581-0001","Drug: Placebo (NNC0581-0001)",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 2: NNC0581-0001 (Dose 2)","Participants will receive a s.c injection of either NNC0581-0001 Dose 2 or a matching placebo once monthly.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","NNC0581-0001","NNC0581-0001 will be administered subcutaneously.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo (NNC0581-0001)","Placebo matched to NNC0581-0001 will be administered subcutaneously.",[9,16],[31],{"name":32,"affiliation":5,"role":33},"Clinical Transparency (dept. 2834)","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Novo Nordisk","CONTACT","(+1) 866-867-7178","clinicaltrials@novonordisk.com",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Parexel Research Unit","RECRUITING","Harrow","HA1 3UJ","United Kingdom","UK",{"type":49,"coordinates":50},"Point",[51,52],-0.33208,51.57835,{"lat":52,"lon":51},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100584593","phase-1-multiple-dose-study-for-a-new-medication-to-potentially-treat-liver-diseases-100584593",false,"NCT06891365","Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases","Investigation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of NNC0581-0001 in Participants With Hepatic Steatosis and Suspected Steatohepatitis","Inclusion Criteria:\n\n* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n* Male or female (of non-childbearing potential) aged 18-69 years (both inclusive) at the time of signing the informed consent.\n* Body mass index (BMI) greater than or equal to (\\>=) 25.0 at screening.\n* Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) \\>= 10 percent at screening.\n\nAdditional inclusion criteria for participants in the open-label liver biopsy cohort apply:\n\n* Alanine aminotransferase (ALT) in men greater than (\\>) 30 units per liter (U\u002FL), women \\> 19 U\u002FL\n* Liverstiffness, measured by FibroScan® (VCTE) \\> 8 kPa and less than (\\\u003C) 12 kPa\n* Informed consent obtained at screening for a liver biopsy to be performed at baseline and post-treatment.\n\nNote: Participants with confirmed metabolic dysfunction-associated steatohepatitis (MASH), based on a prior liver biopsy, can be included in the open-label cohort.\n\nExclusion Criteria:\n\n* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Any laboratory safety parameter, at screening, outside the extended laboratory ranges, and considered clinically significant per the principal investigator (see laboratory provided reference ranges for specific values). Of note, re-screening or re-sampling is NOT allowed if the individual has failed one of the exclusion criteria related to the following laboratory parameters:\n* ALT \\>= 3 × upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) \\>= 3 × ULN\n* Bilirubin \\> 1.5 × ULN\n* Estimated glomerular filtration rate (eGFR) \\\u003C 50 milliliter per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) at screening.\n\nAdditional exclusion criteria for participants in the open-label liver biopsy group apply:\n\n* Medical history of abnormal bleeding\n* BMI \\> 34.9 kilograms per square meters (kg\u002Fm\\^2)\n* Presence of ascites\n* Cirrhosis based on screening tests or historical biopsy\n* Lab abnormalities of platelets count \\\u003C 150 × 10\\^9 per liter or International Normalized Ratio (INR) \\> 1.2\n* Concomitant use of medication:\n* anticoagulants or herbal supplements with an anticoagulative effect (as judged by the principal investigator)\n* antiplatelet medications\n* exception for aspirin that must be stopped 5 days prior to procedure and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) that must not be taken within 3 days of the procedure.","ALL","18 Years","64 Years",{"count":67,"type":68},48,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). NNC0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance. NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.",[74,75],"Healthy Volunteers","Hepatic Steatosis","2026-04-01",{"date":78,"type":79},"2026-04-07","ACTUAL",{"date":81,"type":79},"2025-03-12",{"date":83,"type":68},"2027-11-15",{"name":5,"class":6},1]