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Active, not recruiting Phase 2

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

NCT06471829 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2024-06-19
Last updated
2026-10-16

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)

  • 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 — Up to 490 days

Trial sites (27)

FacilityCityRegionStatus
University of Michigan Health-A. Alfred Taubman Health Care Center Ann Arbor Michigan
Washington University School of Medicine in St. Louis St Louis Missouri
Hospices Civils de Lyon (HCL) - Hopital Louis Pradel - Centre De Reference Maladie De Rendu-Osler Bron Auvergne-Rhône-Alpes
Centre Hospitalier Universitaire de Lille (CHU Lille) Lille Hauts-de-France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque Pessac New Aquitaine
Centre Hospitalier Universitaire d'Angers - Centre de recherche clinique Angers Pays de la Loire Region
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de la Conception - Pole Psychiatrie C... Marseille Provence-Alpes-Côte d'Azur Region
AP-HP - Hôpital Bicêtre Le Kremlin-Bicêtre France
Aversi Clinic - Tbilisi Tbilisi Georgia
Multiprofile Clinic - Consilium Medulla Tbilisi Georgia
Aversi Clinic - Tbilisi Tbilisi Georgia
Pecsi Tudomanyegyetem (PTE) (University of Pecs) Pécs Baranya
Debreceni Egyetem - Klinikai Kozpont - Onkologiai Klinika Debrecen Hajdú-Bihar
Semmelweis Egyetem - Belgyogyaszati es Onkologiai Klinika (I.sz. Belgyogyaszati Klinika) Budapest Hungary
Azienda Ospedaliera Universitaria "Gaetano Martino" - Messina Messina Italy
Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Ospedale Busonera Padua Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To... Pisa Italy
Sapienza Universita di Roma - Azienda Ospedaliera Sant Andre Rome Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Sant'Anna Turin Italy
Uniwersytet Jagiellonski Collegium Medicum - Szpital Uniwersytecki w Krakowie - Katedra i Klinika... Krakow Lesser Poland Voivodeship
Spitalul Clinic Judetean de Urgenta Cluj-Napoca Cluj-Napoca Cluj
Spitalul Clinic Judetean Mures (SCJM) Târgu Mureş Mureș County
Institutul National de Endocrinologie "C.I. Parhon" Bucharest Romania
Hospital de la Santa Creu I Sant Pau Barcelona Spain
Hospital Universitario Ramon y Cajal Madrid Spain
Northern Care Alliance NHS Foundation Trust - North Manchester General Hospital Manchester Europe
University of Birmingham - Institute of Metabolism and Systems Research (IMSR) Birmingham West Midlands
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