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Trial of Lu AG13909 for Cushing's Disease

This study is testing a drug called Lu AG13909 in adults with Cushing's disease (CD). CD is a condition where your body makes too much of a hormone called cortisol. The main goals are to see how Lu AG13909 affects cortisol levels, how safe it is, and how your body processes the drug. To join, you must be between 18 and 70 years old, have a confirmed diagnosis of CD from your pituitary gland, and have certain ACTH levels. We'll know if the treatment is successful if your urinary free cortisol (UFC) levels return to normal by the end of the treatment period, which could be up to 490 days. The current recruitment status is unclear, but 18 participants are planned.

Study design
This is an interventional study with 18 planned participants. It is divided into three parts: Part A, Part B, and an Extension Period.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will have safety follow-up periods after different treatment phases, with the primary endpoint measured up to 490 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06471829

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
H. Lundbeck A/S
~18 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Lu AG13909

At a glance

Recruiting sites
28 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration Period
Measured over Up to 490 days

Conditions

Cushing's Disease

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NCT06471829

Where you'd take part

This study runs at 28 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AOU Citta della Salute e della Scienza di Torino

    Torino, Italyno site contact published

    Recruiting

  • APHP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, Franceno site contact published

    Recruiting

  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de la Conception - Pole Psychiatrie C...

    Marseille, Provence-Alpes-Côte d'Azur Region, Franceno site contact published

    Recruiting

  • Aversi Clinic - Central Branch

    Tbilisi, Europe, Georgiano site contact published

    Recruiting

  • Aversi Clinic - Central Branch

    Tbilisi, Georgiano site contact published

    Recruiting

  • Azienda Ospedale Università di Padova

    Padova, Europe, Italyno site contact published

    Recruiting

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, Europe, Italyno site contact published

    Recruiting

  • Centre Hospitalier Universitaire d'Angers - Centre de recherche clinique

    Angers, Pays de la Loire Region, Franceno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Who to contact

Email contact via H. Lundbeck A/S
[email protected]
+45 36301311
Email the study team

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Eligibility criteria

Inclusion

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:
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

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:
The participant had pituitary surgery \<3 month prior to screening.
The participant had pituitary radiotherapy within the last 10 years.

What this trial measures

  • Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration PeriodUp to 490 days