A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
NCT ID: NCT06471829
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
18 participants
INTERVENTIONAL
2024-06-19
2027-11-30
Brief Summary
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1. the effect of Lu AG13909 on cortisol levels.
2. the safety and tolerability of Lu AG13909.
3. the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).
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Detailed Description
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* Part A, consisting of 3 periods: an intravenous (IV) Titration Period, a subcutaneous (SC) Period, and a Safety Follow up Period
* Part B, consisting of 3 periods: a SC Titration Period, a Maintenance Period, and a Safety Follow-up Period
* Extension Period, consisting of a Long-Term Efficacy/Safety Period after Part B and a Safety Follow-up Period
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lu AG13909
Participants will first receive Lu AG13909 IV per predefined dosing schedule. Participants will then receive Lu AG13909 SC per predefined dosing schedule.
Lu AG13909
Solution for injection/infusion
Interventions
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Lu AG13909
Solution for injection/infusion
Eligibility Criteria
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Inclusion Criteria
* Morning plasma ACTH levels \> lower limit of normal (LLN) and
* Evidence of a pituitary origin of the excess ACTH:
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
* The participant has a 24-hour UFC \>1.5 × ULN (the mean of ≥3 days of 24-hour urine collection).
* 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.
* For participants on medical treatment for hypercortisolism due to CD, pre-defined washout periods must be completed prior to the Baseline efficacy assessments.
Exclusion Criteria
* 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.
* The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.
* The participant has immediate need for pituitary surgery within 6 months from screening in the opinion of the investigator.
* The participant has severe CD per investigator judgement; among others, this could be participants with:
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
* The participant had pituitary surgery \<3 month prior to screening.
* The participant had pituitary radiotherapy within the last 10 years.
Other protocol-defined criteria apply.
18 Years
70 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Centre Hospitalier Universitaire d'Angers
Angers, Cedex 09, France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
Marseille, Europe, France
Hopital Louis Pradel
Bron, , France
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Centre Hospitalier Universitaire De Lille
Lille, , France
Hopital Haut-Leveque
Pessac, , France
Ltd Tbilisi Central Hospital
Tbilisi, Europe, Georgia
National Institute of Endocrinology
Tbilisi, Europe, Georgia
Ltd 'Multiprofile Clinic Consilium Medulla'
Tbilisi, Europe, Georgia
Ltd Aversi Clinic
Tbilisi, , Georgia
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
University Hospital of Pecs
Pécs, , Hungary
Azienda Ospedale Università di Padova
Padua, Europe, Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, Europe, Italy
Azienda Ospedaliera Universitaria Sant'Andrea
Rome, , Italy
AOU Citta della Salute e della Scienza di Torino
Torino, , Italy
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Clju-Napoca, , Romania
Spitalul Clinic Judetean Mures
Mures, , Romania
Hospital de la Santa Creu i de Sant Pau
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
University of Birmingham Institute of Metabolism and Systems Research
Birmingham, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-504733-53-00
Identifier Type: OTHER
Identifier Source: secondary_id
20433A
Identifier Type: -
Identifier Source: org_study_id
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