NCT06471829

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cushing's Disease

Interventions

Type	Name	Description
DRUG	Lu AG13909	Solution for injection/infusion

Timeline

• Start date: 2024-06-19
• Primary completion: 2026-09-15
• Completion: 2027-11-30
• First posted: 2024-06-24
• Last updated: 2026-02-18

Locations

26 sites across 8 countries: United States, France, Georgia, Hungary, Italy, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study