CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 42 target
Drug / intervention
Lu AG13909drug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Confirmed diagnosis of 21-hydroxylase deficiency CAH based on pathogenic CYP21A2 variant and/or elevated 17-OHP
  • ✓BMI ≥18.5 and ≤40 kg/m² (minimum 50 kg)
  • ✓Stable GC replacement therapy for ≥1 month prior to Screening Visit
  • ✓For salt-wasting form, stable mineralocorticoid replacement for ≥3 months prior to Screening Visit (Parts A/B) or ≥1 month (Part C)
Key exclusion· 4
  • ✕Pregnant or breastfeeding
  • ✕Clinically significant abnormal laboratory value, ECG parameter, vital signs, or other safety findings at Screening Visit indicating potential risk
  • ✕Known hypersensitivity or intolerance to Lu AG13909 or its excipients
  • ✕Part C only: Previously received at least one dose of Lu AG13909 in Part A or Part B

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05669950
NCT05669950Phase 2RecruitingOn TrackUpdated 3mo ago
Long Recruiting
CompareCT.gov

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

H. Lundbeck A/S·interventional·Posted Jan 3, 2023·Updated Mar 9, 2026

In Brief

A Phase 2 clinical trial evaluating Lu AG13909 for Congenital Adrenal Hyperplasia. Currently recruiting, targeting 42 participants across 17 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Adrenal Hyperplasia
CountriesDenmark, France, Georgia, Ireland, Italy, Poland, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 2Recruiting
202320242025202620272028
First PostedJan 3, 2023
Enrollment StartDec 19, 2022
Primary CompletionSep 30, 2026
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 3.5 years agoPrimary completion in 3 months

Interventions

Lu AG13909drug

Solution for infusion