Back to Trials
NCT06471829PHASE2Recruiting

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

H. Lundbeck A/S

Start Date

6/19/2024

Completion Date

10/31/2027

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).

Detailed Description

This trial is divided into 3 parts: * Part A, consisting of 3 periods: an intravenous (IV) Titration Period, a subcutaneous (SC) Period, and a Safety Follow up Period * Part B, consisting of 3 periods: a SC Titration Period, a Maintenance Period, and a Safety Follow-up Period * Extension Period, consisting of a Long-Term Efficacy/Safety Period after Part B and a Safety Follow-up Period

Eligibility Criteria

Age Range: 18 years to 70 years

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.

Interventions

DRUG

Lu AG13909

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Cushing's Disease

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States

Centre Hospitalier Universitaire d'Angers

Angers, Cedex 09 49933

France

Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception

Marseille, Europe 13005

France

Hopital Louis Pradel

Bron, 69677

France

APHP - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275

France

Centre Hospitalier Universitaire De Lille

Lille, 59000

France

Hopital Haut-Leveque

Pessac, 33604

France

Ltd Tbilisi Central Hospital

Tbilisi, Europe 0159

Georgia

National Institute of Endocrinology

Tbilisi, Europe 0159

Georgia

Multiprofile Clinic Consilium Medulla Ltd

Tbilisi, Europe 0186

Georgia

Ltd Aversi Clinic

Tbilisi, 160

Georgia

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

Budapest, 1083

Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032

Hungary

University Hospital of Pecs

Pécs, 7624

Hungary

Azienda Ospedale Università di Padova

Padova, Europe 35128

Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, Europe 56124

Italy

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

Messina, Sicily 98124

Italy

Azienda Ospedaliera Universitaria Sant'Andrea

Rome, 00189

Italy

AOU Citta della Salute e della Scienza di Torino

Torino, 10126

Italy

University Hospital in Krakow

Krakow, 30-688

Poland

Institutul National de Endocrinologie "C.I. Parhon"

Bucharest, 011863

Romania

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Clju-Napoca, 400347

Romania

Spitalul Clinic Judetean Mures

Mures, 540139

Romania

Hospital de la Santa Creu i de Sant Pau

Barcelona, 08041

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Northern Care Alliance, North Manchester General Hospital

Manchester, Europe M8 5RB

United Kingdom

University of Birmingham Institute of Metabolism and Systems Research

Birmingham, B15 2TT

United Kingdom