Poienita

This trial investigates the effects of Lu AG13909 in adults with Cushings disease, a rare condition caused by excess cortisol production. The study aims to evaluate how Lu AG13909 affects cortisol levels, as well as its safety, tolerability, and how the body processes the drug. This is a Phase II, open-label trial sponsored by H. Lundbeck AS. The trial is divided into three parts Part A includes intravenous IV titration, subcutaneous SC dosing, and a safety follow-up Part B involves SC titration, maintenance dosing, and another safety follow-up and an Extension Period focuses on long-term efficacy, safety, and continued monitoring. Participants receive Lu AG13909 first by IV and then by SC according to predefined dosing schedules. Participants will undergo regular assessments including urine and blood tests to measure cortisol and drug levels, safety evaluations, and monitoring for adverse effects. The main outcome is the reduction of urinary free cortisol to normal levels. The trial lasts up to about 490 days for initial periods, with extended follow-up up to 1037 days to assess long-term effects and safety.