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

Recruiting now · Phase 2

Conditions studied: Cushing's Disease

In brief

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).

Key facts

Study ID

NCT06471829

Run by

H. Lundbeck A/S

People needed

18

Starts

2024-06-19

Expected to finish

2027-10-31

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Centre Hospitalier Universitaire d'Angers — Angers, Cedex 09, France (enrolling)
• Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception — Marseille, Europe, France (enrolling)
• Hopital Louis Pradel — Bron, France (enrolling)
• APHP - Hôpital Bicêtre — Le Kremlin-Bicêtre, France (enrolling)
• Centre Hospitalier Universitaire De Lille — Lille, France (enrolling)
• Hopital Haut-Leveque — Pessac, France (enrolling)
• Ltd Tbilisi Central Hospital — Tbilisi, Europe, Georgia (enrolling)
• National Institute of Endocrinology — Tbilisi, Europe, Georgia (enrolling)
• Multiprofile Clinic Consilium Medulla Ltd — Tbilisi, Europe, Georgia (enrolling)
• Ltd Aversi Clinic — Tbilisi, Georgia (enrolling)
• Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika — Budapest, Hungary (enrolling)
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary (enrolling)
• University Hospital of Pecs — Pécs, Hungary (enrolling)
• Azienda Ospedale Università di Padova — Padova, Europe, Italy (enrolling)
• Azienda Ospedaliero-Universitaria Pisana — Pisa, Europe, Italy (enrolling)
• Università degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico 'Gaetano Martino' — Messina, Sicily, Italy (enrolling)
• Azienda Ospedaliera Universitaria Sant'Andrea — Rome, Italy (enrolling)
• AOU Citta della Salute e della Scienza di Torino — Torino, Italy (enrolling)
• University Hospital in Krakow — Krakow, Poland (enrolling)
• Institutul National de Endocrinologie "C.I. Parhon" — Bucharest, Romania (enrolling)
• Spitalul Clinic Judetean de Urgenta Cluj-Napoca — Clju-Napoca, Romania (enrolling)
• Spitalul Clinic Judetean Mures — Mures, Romania (enrolling)
• Hospital de la Santa Creu i de Sant Pau — Barcelona, Spain (enrolling)
• Hospital Universitario Ramon y Cajal — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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