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ACTIVE NOT RECRUITING

NCT06471829

PHASE2

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

Sponsor: H. Lundbeck A/S

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06-19

Completion Date

2027-10-31

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Cushing's Disease

Interventions

DRUG

Lu AG13909

Solution for injection/infusion

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.

Locations (27)

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

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, Hungary

Debreceni Egyetem - Klinikai Kozpont - Onkologiai Klinika

Debrecen, Hajdú-Bihar, Hungary

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, 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 NHS Foundation Trust - North Manchester General Hospital

Manchester, Europe, United Kingdom

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

Birmingham, West Midlands, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (27)