A Trial of Lu AG13909 in Adult Participants With Cushing's Disease

Study Purpose

This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). Cushing's disease 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. 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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- The participant is a man or woman with a confirmed diagnosis of adrenocorticotropic hormone (ACTH) driven CD of pituitary source as per current guidelines.

- 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 >3 after stimulation with corticotropin-releasing hormone (CRH). Otherwise, >2. 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 disease manifestations (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 is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate contraceptive methods.

- 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: - poorly controlled hypertension.

- poorly controlled diabetes mellitus.

- severe psychiatric illness.

- compression of the optic chiasm causing any visual field defect or risk thereof.

- very high risk of thromboembolic events.

- The participant had pituitary surgery <3 month prior to screening.

- The participant had previous pituitary radiotherapy.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06471829
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	H. Lundbeck A/S
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	France, Georgia, Hungary, Italy, Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cushing's Disease

Arms & Interventions

Arms

Experimental: Lu AG13909

Participants will first receive Lu AG13909 intravenously (IV) per predefined dosing schedule. Participants will then receive Lu AG13909 subcutaneously (SC) per predefined dosing schedule.

Interventions

Drug: - Lu AG13909

Solution for injection/infusion

Contact a Trial Team

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