[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552341":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":60,"studyPopulation":11,"armGroups":61,"interventions":68,"overallOfficials":73,"centralContacts":78,"locations":82,"responsibleParty":357,"collaborators":11,"id":359,"slug":360,"hasResults":361,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":361,"sex":367,"minAge":368,"maxAge":369,"enrollmentInfo":370,"targetDuration":11,"studyType":373,"phases":374,"briefSummary":376,"conditions":377,"keywords":11,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":388},{"fullName":5,"class":6},"H. Lundbeck A\u002FS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV\u002FSC Titration Period",null,"Up to 490 days",[14,17,20,22,24,26,28,30,33,35,38,40,43,46,49,52],{"measure":15,"description":11,"timeFrame":16},"Number of Participants With Treatment-Emergent Adverse Events (TEAEs)","Up to 1023 days",{"measure":18,"description":11,"timeFrame":19},"AUC0-tau,ss: Area Under the Plasma Concentration Curve of Lu AG13909 at Steady State","Up to 1037 days",{"measure":21,"description":11,"timeFrame":19},"CL: Systemic Clearance of Lu AG13909",{"measure":23,"description":11,"timeFrame":19},"t½: Elimination Half-life of Lu AG13909",{"measure":25,"description":11,"timeFrame":19},"Vd: Apparent Volume of Distribution of Lu AG13909",{"measure":27,"description":11,"timeFrame":19},"SC Bioavailability (F) of Lu AG13909",{"measure":29,"description":11,"timeFrame":19},"Number of Participants With Anti-Drug Antibodies (ADAs)",{"measure":31,"description":11,"timeFrame":32},"Part A Only: Cmax: Maximum Observed Plasma Concentration of Lu AG13909","Up to 323 days",{"measure":34,"description":11,"timeFrame":32},"Part A Only: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Lu AG13909",{"measure":36,"description":11,"timeFrame":37},"Part A & Part B: Ctrough: Minimum Observed Concentration of Lu AG13909","Up to 659 days",{"measure":39,"description":11,"timeFrame":37},"Part A & Part B: Ttrough: Nominal Time Corresponding to the Occurrence of Ctrough",{"measure":41,"description":11,"timeFrame":42},"UFC Complete Response (mUFC ≤ ULN) or Partial Response (≥50% Reduction in UFC from Baseline and mUFC >ULN) at the End of the IV\u002FSC Titration Period","Up to 491 days",{"measure":44,"description":11,"timeFrame":45},"Maintenance of UFC Complete Response (mUFC ≤ULN) at the End of the Part B Maintenance Period","Up to 337 days",{"measure":47,"description":11,"timeFrame":48},"Part A and Part B: Percentage Change from Baseline in mUFC at the End of the Titration Period and the Completion Visit","Baseline, up to 561 days",{"measure":50,"description":11,"timeFrame":51},"Part A and Part B: UFC Complete Response (mUFC ≤ ULN) or Partial Response (≥50% Reduction in UFC from Baseline and mUFC >ULN) at the Completion Visit","Up to 561 days",{"measure":53,"description":11,"timeFrame":51},"Part A and Part B: Late Night Salivary Cortisol (LNSC) Complete Response (Mean LNSC (mLNSC)≤ULN) or Partial Response (≥50% Reduction from Baseline in LNSC and mLNSC >ULN) at the End of the Titration Period and the Completion Visit",{"allocation":55,"interventionModel":56,"interventionModelDescription":11,"primaryPurpose":57,"observationalModel":11,"timePerspective":11,"maskingInfo":58},"NA","SINGLE_GROUP","TREATMENT",{"masking":59,"maskingDescription":11,"whoMasked":11},"NONE","This trial is divided into 3 parts:\n\n* Part A, consisting of 3 periods: an intravenous (IV) Titration Period, a subcutaneous (SC) Period, and a Safety Follow up Period\n* Part B, consisting of 3 periods: a SC Titration Period, a Maintenance Period, and a Safety Follow-up Period\n* Extension Period, consisting of a Long-Term Efficacy\u002FSafety Period after Part B and a Safety Follow-up Period",[62],{"label":63,"type":64,"description":65,"interventionNames":66},"Lu AG13909","EXPERIMENTAL","Participants will first receive Lu AG13909 IV per predefined dosing schedule. Participants will then receive Lu AG13909 SC per predefined dosing schedule.",[67],"Drug: Lu AG13909",[69],{"type":70,"name":63,"description":71,"armGroupLabels":72,"otherNames":11},"DRUG","Solution for injection\u002Finfusion",[63],[74],{"name":75,"affiliation":76,"role":77},"Email contact via H. Lundbeck A\u002FS","HQ_Medinfo@Lundbeck.com","STUDY_DIRECTOR",[79],{"name":75,"role":80,"phone":81,"phoneExt":11,"email":76},"CONTACT","+45 36301311",[83,97,107,119,129,139,149,159,168,180,186,192,196,208,217,226,237,246,256,265,274,285,297,307,316,327,336,347],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":11},"University of Michigan Health-A. Alfred Taubman Health Care Center","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-83.74088,42.27756,{"lat":95,"lon":94},{"facility":98,"status":85,"city":99,"state":100,"zip":101,"country":89,"countryCode":90,"cosmosGeoPoint":102,"geoPoint":106,"contacts":11},"Washington University School of Medicine in St. Louis","St Louis","Missouri","63110-1010",{"type":92,"coordinates":103},[104,105],-90.19789,38.62727,{"lat":105,"lon":104},{"facility":108,"status":85,"city":109,"state":110,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":11},"Hospices Civils de Lyon (HCL) - Hopital Louis Pradel - Centre De Reference Maladie De Rendu-Osler","Bron","Auvergne-Rhône-Alpes","69677","France","FR",{"type":92,"coordinates":115},[116,117],4.91303,45.73865,{"lat":117,"lon":116},{"facility":120,"status":85,"city":121,"state":122,"zip":123,"country":112,"countryCode":113,"cosmosGeoPoint":124,"geoPoint":128,"contacts":11},"Centre Hospitalier Universitaire de Lille (CHU Lille)","Lille","Hauts-de-France","59000",{"type":92,"coordinates":125},[126,127],3.05512,50.63391,{"lat":127,"lon":126},{"facility":130,"status":85,"city":131,"state":132,"zip":133,"country":112,"countryCode":113,"cosmosGeoPoint":134,"geoPoint":138,"contacts":11},"Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque","Pessac","New Aquitaine","33604",{"type":92,"coordinates":135},[136,137],-0.6324,44.80565,{"lat":137,"lon":136},{"facility":140,"status":85,"city":141,"state":142,"zip":143,"country":112,"countryCode":113,"cosmosGeoPoint":144,"geoPoint":148,"contacts":11},"Centre Hospitalier Universitaire d'Angers - Centre de recherche clinique","Angers","Pays de la Loire Region","49933",{"type":92,"coordinates":145},[146,147],-0.55202,47.47156,{"lat":147,"lon":146},{"facility":150,"status":85,"city":151,"state":152,"zip":153,"country":112,"countryCode":113,"cosmosGeoPoint":154,"geoPoint":158,"contacts":11},"Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de la Conception - Pole Psychiatrie C...","Marseille","Provence-Alpes-Côte d'Azur Region","13005",{"type":92,"coordinates":155},[156,157],5.38107,43.29695,{"lat":157,"lon":156},{"facility":160,"status":85,"city":161,"state":11,"zip":162,"country":112,"countryCode":113,"cosmosGeoPoint":163,"geoPoint":167,"contacts":11},"APHP - Hôpital Bicêtre","Le Kremlin-Bicêtre","94275",{"type":92,"coordinates":164},[165,166],2.36073,48.81471,{"lat":166,"lon":165},{"facility":169,"status":85,"city":170,"state":171,"zip":172,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":11},"Aversi Clinic - Central Branch","Tbilisi","Europe","0160","Georgia","GE",{"type":92,"coordinates":176},[177,178],44.83412,41.69143,{"lat":178,"lon":177},{"facility":181,"status":85,"city":170,"state":171,"zip":182,"country":173,"countryCode":174,"cosmosGeoPoint":183,"geoPoint":185,"contacts":11},"Multiprofile Clinic Consilium Medulla Ltd","0186",{"type":92,"coordinates":184},[177,178],{"lat":178,"lon":177},{"facility":187,"status":85,"city":170,"state":11,"zip":188,"country":173,"countryCode":174,"cosmosGeoPoint":189,"geoPoint":191,"contacts":11},"National Institute of Endocrinology - Prof. Elene Giorgadze Clinic","0159",{"type":92,"coordinates":190},[177,178],{"lat":178,"lon":177},{"facility":169,"status":85,"city":170,"state":11,"zip":172,"country":173,"countryCode":174,"cosmosGeoPoint":193,"geoPoint":195,"contacts":11},{"type":92,"coordinates":194},[177,178],{"lat":178,"lon":177},{"facility":197,"status":85,"city":198,"state":199,"zip":200,"country":201,"countryCode":202,"cosmosGeoPoint":203,"geoPoint":207,"contacts":11},"Debreceni Egyetem - Klinikai Kozpont - Onkologiai Klinika","Debrecen","Hajdú-Bihar","4032","Hungary","HU",{"type":92,"coordinates":204},[205,206],21.62444,47.53167,{"lat":206,"lon":205},{"facility":209,"status":85,"city":210,"state":11,"zip":211,"country":201,"countryCode":202,"cosmosGeoPoint":212,"geoPoint":216,"contacts":11},"Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika","Budapest","1083",{"type":92,"coordinates":213},[214,215],19.04045,47.49835,{"lat":215,"lon":214},{"facility":218,"status":85,"city":219,"state":11,"zip":220,"country":201,"countryCode":202,"cosmosGeoPoint":221,"geoPoint":225,"contacts":11},"University Hospital of Pecs","Pécs","7624",{"type":92,"coordinates":222},[223,224],18.22814,46.07617,{"lat":224,"lon":223},{"facility":227,"status":85,"city":228,"state":171,"zip":229,"country":230,"countryCode":231,"cosmosGeoPoint":232,"geoPoint":236,"contacts":11},"Azienda Ospedale Università di Padova","Padova","35128","Italy","IT",{"type":92,"coordinates":233},[234,235],11.14261,44.38225,{"lat":235,"lon":234},{"facility":238,"status":85,"city":239,"state":171,"zip":240,"country":230,"countryCode":231,"cosmosGeoPoint":241,"geoPoint":245,"contacts":11},"Azienda Ospedaliero-Universitaria Pisana","Pisa","56124",{"type":92,"coordinates":242},[243,244],10.4036,43.70853,{"lat":244,"lon":243},{"facility":247,"status":85,"city":248,"state":249,"zip":250,"country":230,"countryCode":231,"cosmosGeoPoint":251,"geoPoint":255,"contacts":11},"Università degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico 'Gaetano Martino'","Messina","Sicily","98124",{"type":92,"coordinates":252},[253,254],15.55256,38.19394,{"lat":254,"lon":253},{"facility":257,"status":85,"city":258,"state":11,"zip":259,"country":230,"countryCode":231,"cosmosGeoPoint":260,"geoPoint":264,"contacts":11},"Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea","Rome","189",{"type":92,"coordinates":261},[262,263],12.51133,41.89193,{"lat":263,"lon":262},{"facility":266,"status":85,"city":267,"state":11,"zip":268,"country":230,"countryCode":231,"cosmosGeoPoint":269,"geoPoint":273,"contacts":11},"AOU Citta della Salute e della Scienza di Torino","Torino","10126",{"type":92,"coordinates":270},[271,272],11.99138,44.88856,{"lat":272,"lon":271},{"facility":275,"status":85,"city":276,"state":11,"zip":277,"country":278,"countryCode":279,"cosmosGeoPoint":280,"geoPoint":284,"contacts":11},"University Hospital in Krakow","Krakow","30-688","Poland","PL",{"type":92,"coordinates":281},[282,283],19.93658,50.06143,{"lat":283,"lon":282},{"facility":286,"status":85,"city":287,"state":288,"zip":289,"country":290,"countryCode":291,"cosmosGeoPoint":292,"geoPoint":296,"contacts":11},"Spitalul Clinic Judetean de Urgenta Cluj-Napoca","Cluj-Napoca","Cluj","400006","Romania","RO",{"type":92,"coordinates":293},[294,295],23.6,46.76667,{"lat":295,"lon":294},{"facility":298,"status":85,"city":299,"state":300,"zip":301,"country":290,"countryCode":291,"cosmosGeoPoint":302,"geoPoint":306,"contacts":11},"Spitalul Clinic Judetean Mures (SCJM)","Târgu Mureş","Mureș County","540072",{"type":92,"coordinates":303},[304,305],24.55747,46.54245,{"lat":305,"lon":304},{"facility":308,"status":85,"city":309,"state":11,"zip":310,"country":290,"countryCode":291,"cosmosGeoPoint":311,"geoPoint":315,"contacts":11},"Institutul National de Endocrinologie \"C.I. Parhon\"","Bucharest","011863",{"type":92,"coordinates":312},[313,314],26.10626,44.43225,{"lat":314,"lon":313},{"facility":317,"status":85,"city":318,"state":11,"zip":319,"country":320,"countryCode":321,"cosmosGeoPoint":322,"geoPoint":326,"contacts":11},"Hospital de la Santa Creu I Sant Pau","Barcelona","08041","Spain","ES",{"type":92,"coordinates":323},[324,325],2.15899,41.38879,{"lat":325,"lon":324},{"facility":328,"status":85,"city":329,"state":11,"zip":330,"country":320,"countryCode":321,"cosmosGeoPoint":331,"geoPoint":335,"contacts":11},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"type":92,"coordinates":332},[333,334],-3.70256,40.4165,{"lat":334,"lon":333},{"facility":337,"status":85,"city":338,"state":171,"zip":339,"country":340,"countryCode":341,"cosmosGeoPoint":342,"geoPoint":346,"contacts":11},"Northern Care Alliance, North Manchester General Hospital","Manchester","M8 5RB","United Kingdom","UK",{"type":92,"coordinates":343},[344,345],-2.23743,53.48095,{"lat":345,"lon":344},{"facility":348,"status":85,"city":349,"state":350,"zip":351,"country":340,"countryCode":341,"cosmosGeoPoint":352,"geoPoint":356,"contacts":11},"University of Birmingham - Institute of Metabolism and Systems Research (IMSR)","Birmingham","West Midlands","B15 2TT",{"type":92,"coordinates":353},[354,355],-1.89983,52.48142,{"lat":355,"lon":354},{"type":358,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100552341","phase-2-a-trial-of-lu-ag13909-in-adult-participants-with-cushings-disease-100552341",false,"NCT06471829","A Trial of Lu AG13909 in Adult Participants With Cushing's Disease","A Phase II, Multi-site, Open-label, Dose-titration Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AG13909 in Adults With Cushing's Disease","BalanCeD","Inclusion Criteria:\n\n* The participant is a man or woman with a confirmed diagnosis of adrenocorticotropic hormone (ACTH) driven CD of pituitary source as per current guidelines\n* Morning plasma ACTH levels \\> lower limit of normal (LLN) and\n* Evidence of a pituitary origin of the excess ACTH:\n\n  i. Either MRI confirmation of pituitary adenoma \\>6 millimeters (mm), or ii. inferior petrosal sinus gradient \\>2, or iii. histopathology confirmation of ACTH-secreting tumour\n* The participant has a 24-hour UFC \\>1.5 × ULN (the mean of ≥3 days of 24-hour urine collection).\n* Apart from CD and associated well-controlled comorbidities (for example, diabetes mellitus and hypertension), the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the safety laboratory tests.\n* For participants on medical treatment for hypercortisolism due to CD, pre-defined washout periods must be completed prior to the Baseline efficacy assessments.\n\nExclusion Criteria:\n\n* The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate contraceptive methods.\n* The participant has a clinically significant abnormal laboratory value, ECG parameter, vital signs value, or other safety findings at the Screening Visit that indicate a potential risk to the participant's safety if enrolled, in the opinion of the investigator.\n* The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.\n* The participant has immediate need for pituitary surgery within 6 months from screening in the opinion of the investigator.\n* The participant has severe CD per investigator judgement; among others, this could be participants with:\n\n  i. poorly controlled hypertension ii. poorly controlled diabetes mellitus iii. severe psychiatric illness iv. compression of the optic chiasm causing any visual field defect or risk thereof v. very high risk of thromboembolic events\n* The participant had pituitary surgery \\\u003C3 month prior to screening.\n* The participant had pituitary radiotherapy within the last 10 years.\n\nOther protocol-defined criteria apply.","ALL","18 Years","70 Years",{"count":371,"type":372},18,"ESTIMATED","INTERVENTIONAL",[375],"PHASE2","This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). CD is a rare and serious disorder where the body makes too much of a hormone called cortisol. The main goals of this trial are to learn about\n\n1. the effect of Lu AG13909 on cortisol levels.\n2. the safety and tolerability of Lu AG13909.\n3. the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).",[378],"Cushing's Disease","2026-08-20",{"date":381,"type":382},"2026-08-21","ACTUAL",{"date":384,"type":382},"2024-06-19",{"date":386,"type":372},"2027-10-31",{"name":5,"class":6},28]