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Clinical Trials in the USA / NCT06471829
Recruiting Phase 2

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

NCT06471829 · tracked via the Priya Life Science USA tracker
Sponsor
H. Lundbeck A/S
Phase
Phase 2
Started
2024-06-19
Last updated
2026-08-21

Condition(s) studied

Cushing's Disease

Investigational drug(s) / intervention(s)

Lu AG13909

Lu AG13909: Solution for injection/infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
University of Michigan Health-A. Alfred Taubman Health Care Center Ann Arbor Michigan Recruiting
Washington University School of Medicine in St. Louis St Louis Missouri Recruiting
Hospices Civils de Lyon (HCL) - Hopital Louis Pradel - Centre De Reference Maladie De Rendu-Osler Bron Auvergne-Rhône-Alpes Recruiting
Centre Hospitalier Universitaire de Lille (CHU Lille) Lille Hauts-de-France Recruiting
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque Pessac New Aquitaine Recruiting
Centre Hospitalier Universitaire d'Angers - Centre de recherche clinique Angers Pays de la Loire Region Recruiting
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de la Conception - Pole Psychiatrie C... Marseille Provence-Alpes-Côte d'Azur Region Recruiting
APHP - Hôpital Bicêtre Le Kremlin-Bicêtre France Recruiting
Aversi Clinic - Central Branch Tbilisi Europe Recruiting
Multiprofile Clinic Consilium Medulla Ltd Tbilisi Europe Recruiting
National Institute of Endocrinology - Prof. Elene Giorgadze Clinic Tbilisi Georgia Recruiting
Aversi Clinic - Central Branch Tbilisi Georgia Recruiting
Debreceni Egyetem - Klinikai Kozpont - Onkologiai Klinika Debrecen Hajdú-Bihar Recruiting
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika Budapest Hungary Recruiting
University Hospital of Pecs Pécs Hungary Recruiting
Azienda Ospedale Università di Padova Padova Europe Recruiting
Azienda Ospedaliero-Universitaria Pisana Pisa Europe Recruiting
Università degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico 'Gaetano Martino' Messina Sicily Recruiting
Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea Rome Italy Recruiting
AOU Citta della Salute e della Scienza di Torino Torino Italy Recruiting
University Hospital in Krakow Krakow Poland Recruiting
Spitalul Clinic Judetean de Urgenta Cluj-Napoca Cluj-Napoca Cluj Recruiting
Spitalul Clinic Judetean Mures (SCJM) Târgu Mureş Mureș County Recruiting
Institutul National de Endocrinologie "C.I. Parhon" Bucharest Romania Recruiting
Hospital de la Santa Creu I Sant Pau Barcelona Spain Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
Northern Care Alliance, North Manchester General Hospital Manchester Europe Recruiting
University of Birmingham - Institute of Metabolism and Systems Research (IMSR) Birmingham West Midlands Recruiting

More H. Lundbeck A/S trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06471829 on ClinicalTrials.gov ↗ ← All trials in the USA