RecruitingPhase 2NCT06471829

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

A Phase II, Multi-site, Open-label, Dose-titration Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AG13909 in Adults With Cushing's Disease

Sponsor

H. Lundbeck A/S

Enrollment

18 participants

Start Date

Jun 19, 2024

Study Type

INTERVENTIONAL

Conditions

Cushing's Disease

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lu AG13909 for people with cushing's disease. The study is currently recruiting participants at 27 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLu AG13909

Solution for injection/infusion

Locations(28)

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

Ann Arbor, Michigan, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

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

Bron, Auvergne-Rhône-Alpes, France

Centre Hospitalier Universitaire de Lille (CHU Lille)

Lille, Hauts-de-France, France

Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque

Pessac, New Aquitaine, France

Centre Hospitalier Universitaire d'Angers - Centre de recherche clinique

Angers, Pays de la Loire Region, France

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

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

APHP - Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Aversi Clinic - Central Branch

Tbilisi, Europe, Georgia

Multiprofile Clinic Consilium Medulla Ltd

Tbilisi, Europe, Georgia

National Institute of Endocrinology - Prof. Elene Giorgadze Clinic

Tbilisi, Georgia

Aversi Clinic - Central Branch

Tbilisi, Georgia

Debreceni Egyetem - Klinikai Kozpont - Onkologiai Klinika

Debrecen, Hajdú-Bihar, Hungary

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

Budapest, Hungary

University Hospital of Pecs

Pécs, Hungary

Azienda Ospedale Università di Padova

Padova, Europe, Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, Europe, Italy

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

Messina, Sicily, Italy

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

Rome, Italy

AOU Citta della Salute e della Scienza di Torino

Torino, Italy

University Hospital in Krakow

Krakow, Poland

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, Cluj, Romania

Spitalul Clinic Judetean Mures (SCJM)

Târgu Mureş, Mureș County, Romania

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, North Manchester General Hospital

Manchester, Europe, United Kingdom

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

Birmingham, West Midlands, United Kingdom

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NCT06471829

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