A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
Condition(s) studied
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More H. Lundbeck A/S trials in the USA
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