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RECRUITING
NCT05669950
PHASE1/PHASE2

A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Sponsor: H. Lundbeck A/S

View on ClinicalTrials.gov

Summary

This trial will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH. CAH is a rare genetic disorder that affects a person's ability to produce certain hormones. The main goals of this trial are to learn about the safety and tolerability of Lu AG13909, how Lu AG13909 behaves in the body, and how the body responds to Lu AG13909.

Official title: A Multi-site, Open-label, Sequential-group, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2022-12-19

Completion Date

2027-12-31

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Lu AG13909

Solution for infusion

Locations (17)

University Hospital-University of Michigan

Ann Arbor, Michigan, United States

Rigshospitalet

Copenhagen, Denmark

Chu Angers

Angers, France

CHU de Lille

Lille, France

GH Pitié-Salpêtrière

Paris, France

CHRU Strasbourg

Strasbourg, France

David Metreveli Medical Centre, Tbilisi

Tbilisi, Georgia

Beaumont Hospital Royal College of Surgeons in Ireland (RCSI), Dublin

Dublin, Ireland

Azienda Ospedaliero Universitaria di Bologna

Bologna, Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma

Roma, Italy

Centrum Nowoczesnych Terapii, Dobry Lekarz

Dobry Lekarz, Poland

Sahlgrenska University Hospital

Gothenburg, Sweden

Karolinska University Hospital

Stockholm, Sweden

NIHR/Wellcome Trust Clinical Research Facility

Birmingham, United Kingdom

Cambridge Clinical Research Centre

Cambridge, United Kingdom

NIHR Clinical Research Facility

London, United Kingdom

University College London Hospital - NIHR

London, United Kingdom