A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
← catalyst calendarNCT05669950 · readout in 42 d
Sponsored by H. Lundbeck A/S (industry) · HLUN-B.CO — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
42estimated
Sites
17
Countries
Denmark, France, Georgia +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-12-19 | actual | When the study began enrolling |
| Primary completion | 2026-09-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2023-01-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Congenital Adrenal Hyperplasia
Intervention
- Drug: Lu AG13909
Primary outcomes
what the primary-completion date above is the date OFParts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
measured Up to Day 161
Parts A and B: Number of Participants With Anti-Drug Antibodies (ADAs)
measured Day 1 up to Day 161
Parts A and B: Cmax: Maximum Observed Serum Concentration of Lu AG13909
measured 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax
measured 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: Ctrough: Minimum Observed Serum Concentration of Lu AG13909
measured 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: t½: Apparent Elimination Half-life of Lu AG13909
measured 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: AUC0-infinity: Area under the plasma concentration curve of x from zero to infinity of Lu AG13909
measured 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: CL: Apparent Total Serum Clearance of Lu AG13909
measured 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: Vz: Volume of Distribution During the Terminal Elimination Phase After IV Administration of Lu AG13909
measured 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: Change From Baseline After Each Dose of Lu AG13909 in Blood Concentrations of 17-hydroxyprogesterone (17-OHP) and Androstenedione (A4)
measured Baseline up to Day 85
Parts A and B: AUC0-tau: Area under the curve over a dosing interval
measured 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Part C: Morning Concentration of A4 in Blood <Upper Limit of Normal (ULN)
measured Day 169
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