A Trial of Lu AG13909 in Adult Participants with Cushing’s Disease
Research type
Research Study
Full 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.
IRAS ID
1011253
Contact name
Shilpa Kulkarni
Contact email
Sponsor organisation
H. Lundbeck A/S (Lundbeck)
Eudract number
2023-504733-53
Clinicaltrials.gov Identifier
Research summary
This trial is an interventional, multi-site, open-label, multiple-ascending-dose trial with dose titration. It will evaluate the effects of Lu AG13909 in adult participants with Cushing’s disease. The main goals of this study are to learn about: a)The effect of Lu AG13909 on cortisol levels,
b) The safety and tolerability of Lu AG13909, and c) The pharmacokinetic parameters of Lu AG13909 (how the trial study drug is absorbed, distributed, and processed by the body) The trial is divided into three parts: Part A, consisting of 3 periods: an IV Titration Period, a 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
Participants will attend only one Safety Follow-up Period before leaving the trial either after Part A, Part B, or the Extension Period. The total duration for Part B will be between 32 weeks and 52 weeks. Extension period will be 52 weeks. Part A is NA for UK. The trial will include adult men and women (18-70 years of age) with Cushing’s Disease who have a confirmed diagnosis of ACTH driven Cushing’s disease of pituitary source as per current guidelines. The trial drug has a therapeutic potential in the treatment of Cushing’s disease, which is characterized by chronically elevated ACTH and cortisol. In Cushing’s disease, there is a high unmet need for medical therapies. Several products are approved for pharmacological treatment of Cushing’s disease, but many have safety concerns and/or limited efficacy. It is possible that by participating in this trial, the participant’s condition may improve, but this cannot be guaranteed. Regardless of whether the individual participant benefits from participating in this trial, participation will contribute to the development of a potential future treatment option for Cushing’s disease.REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0041
Date of REC Opinion
21 Feb 2025
REC opinion
Further Information Favourable Opinion