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New hope for rare hormone disorder: drug targets Out-of-Control cortisol

NCT ID NCT06471829

Disease control Sponsor: H. Lundbeck A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study tests a new drug called Lu AG13909 in 18 adults with Cushing's disease, a rare condition where the body produces too much cortisol. The goal is to see if the drug can safely lower cortisol levels to normal. Participants will receive the drug through an IV or injection, and researchers will monitor how the body processes it and any side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ACTH-dependent Cushing syndrome Cushing disease due to pituitary adenoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cushing's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    28 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AOU Citta della Salute e della Scienza di Torino

    RECRUITING

    Torino, 10126, Italy

  • APHP - Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, 94275, France

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

    RECRUITING

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France

  • Aversi Clinic - Central Branch

    RECRUITING

    Tbilisi, Europe, 0160, Georgia

  • Aversi Clinic - Central Branch

    RECRUITING

    Tbilisi, 0160, Georgia

  • Azienda Ospedale Università di Padova

    RECRUITING

    Padova, Europe, 35128, Italy

  • Azienda Ospedaliero-Universitaria Pisana

    RECRUITING

    Pisa, Europe, 56124, Italy

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

    RECRUITING

    Angers, Pays de la Loire Region, 49933, France

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque

    RECRUITING

    Pessac, New Aquitaine, 33604, France

  • Centre Hospitalier Universitaire de Lille (CHU Lille)

    RECRUITING

    Lille, Hauts-de-France, 59000, France

  • Debreceni Egyetem - Klinikai Kozpont - Onkologiai Klinika

    RECRUITING

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Hospices Civils de Lyon (HCL) - Hopital Louis Pradel - Centre De Reference Maladie De Rendu-Osler

    RECRUITING

    Bron, Auvergne-Rhône-Alpes, 69677, France

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital de la Santa Creu I Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Institutul National de Endocrinologie "C.I. Parhon"

    RECRUITING

    Bucharest, 011863, Romania

  • Multiprofile Clinic Consilium Medulla Ltd

    RECRUITING

    Tbilisi, Europe, 0186, Georgia

  • National Institute of Endocrinology - Prof. Elene Giorgadze Clinic

    RECRUITING

    Tbilisi, 0159, Georgia

  • Northern Care Alliance, North Manchester General Hospital

    RECRUITING

    Manchester, Europe, M8 5RB, United Kingdom

  • Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

    RECRUITING

    Budapest, 1083, Hungary

  • Spitalul Clinic Judetean Mures (SCJM)

    RECRUITING

    Târgu Mureş, Mureș County, 540072, Romania

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    RECRUITING

    Cluj-Napoca, Cluj, 400006, Romania

  • Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea

    RECRUITING

    Rome, 189, Italy

  • University Hospital in Krakow

    RECRUITING

    Krakow, 30-688, Poland

  • University Hospital of Pecs

    RECRUITING

    Pécs, 7624, Hungary

  • University of Birmingham - Institute of Metabolism and Systems Research (IMSR)

    RECRUITING

    Birmingham, West Midlands, B15 2TT, United Kingdom

  • University of Michigan Health-A. Alfred Taubman Health Care Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Università degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico 'Gaetano Martino'

    RECRUITING

    Messina, Sicily, 98124, Italy

  • Washington University School of Medicine in St. Louis

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.