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Evaluating Lu AG13909 for treating Cushing's Disease in adults

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

Phase 2 Interventional H. Lundbeck A/S · NCT06471829

This study is testing a new drug called Lu AG13909 to see if it can help adults with Cushing's disease lower their cortisol levels and improve their health.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment18 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorH. Lundbeck A/S Industry-sponsored
Locations26 sites (Ann Arbor, Michigan and 25 other locations)
Trial IDNCT06471829 on ClinicalTrials.gov

What this trial studies

This trial assesses the effects of Lu AG13909 on cortisol levels in adults diagnosed with Cushing's disease, a condition characterized by excessive cortisol production. The study is structured into three parts: an intravenous titration phase, a subcutaneous administration phase, and a long-term efficacy and safety follow-up. Key objectives include evaluating the drug's safety, tolerability, and pharmacokinetics. Participants will undergo various assessments to ensure their health and suitability for the trial.

Who should consider this trial

Good fit: Ideal candidates are adults with confirmed ACTH-driven Cushing's disease and specific diagnostic criteria met.

Not a fit: Patients without a confirmed diagnosis of ACTH-driven Cushing's disease or those with uncontrolled comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce cortisol levels and improve the quality of life for patients with Cushing's disease.

How similar studies have performed: While there have been studies on Cushing's disease treatments, the specific approach of using Lu AG13909 is novel and has not been extensively tested.

Eligibility criteria

Show full 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 \>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.

Where this trial is running

Ann Arbor, Michigan and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cushing's Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.