NCT05669950

A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (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 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.

Conditions

• Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Lu AG13909	Solution for infusion

Timeline

• Start date: 2022-12-19
• Primary completion: 2026-09-30
• Completion: 2027-12-31
• First posted: 2023-01-03
• Last updated: 2026-03-09

Locations

17 sites across 9 countries: United States, Denmark, France, Georgia, Ireland, Italy, Poland, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study