NCT06471829 A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
| NCT ID | NCT06471829 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | H. Lundbeck A/S |
| Condition | Cushing's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-06-19 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 18 participants in total. It began in 2024-06-19 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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).
Eligibility 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 \>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 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: 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.
Contact & Investigator
Email contact via H. Lundbeck A/S
STUDY DIRECTOR
HQ_Medinfo@Lundbeck.com
Frequently Asked Questions
Who can join the NCT06471829 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Cushing's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06471829 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06471829 currently recruiting?
Yes, NCT06471829 is actively recruiting participants. Contact the research team at HQ_Medinfo@Lundbeck.com for enrollment information.
Where is the NCT06471829 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Angers, France, Marseille, France, Bron, France and 11 additional locations.
Who is sponsoring the NCT06471829 clinical trial?
NCT06471829 is sponsored by H. Lundbeck A/S. The principal investigator is Email contact via H. Lundbeck A/S at HQ_Medinfo@Lundbeck.com. The trial plans to enroll 18 participants.