Recruiting
Phase 1
Phase 2

Lu AG13909

Sponsor:

H. Lundbeck A/S

Code:

NCT05669950

Conditions

Congenital Adrenal Hyperplasia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Lu AG13909

Study Details

Brief 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

Study ID

NCT05669950

Start date

Dec 19, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

Parts A and B:

  • Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant and/or elevated 17-OHP).
  • Morning (pre-glucocorticoid \[GC\] replacement dose) blood concentrations of 17-OHP >4-times upper limit of normal (ULN).
  • Body mass index (BMI) ≥18.5 kilograms (kg)/square meter (m\^2) (minimum 50 kg) and ≤40 kg/m\^2.
  • Stable GC replacement therapy for ≥1 month prior to the Screening Visit.
  • For the salt-wasting form of CAH, the participant must have been on a stable dose of mineralocorticoid replacement for ≥3 months prior to the Screening Visit.
  • Apart from CAH, the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, ECGs, and the results of the safety laboratory tests.

Part C:

  • Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant and/or elevated 17-OHP).
  • For Cohort C1 only: Morning (pre-GC replacement dose) blood concentrations of androgens (A4) > ULN for age and sex.
  • For Cohort C2 only: Morning (pre-GC replacement dose) blood concentrations of androgens (A4) ≤ ULN for age and sex and the participant is treated with high doses of GC.
  • Stable GC replacement therapy for ≥1 month prior to the Screening Visit.
  • For the salt-wasting form of CAH, the participant must have been on a stable dose of mineralocorticoid replacement for ≥1 month prior to the Screening Visit.

Exclusion Criteria:

  • The participant is pregnant or breastfeeding.
  • The participant has a clinically significant abnormal laboratory value, electrocardiogram (ECG) parameter, or vital signs value, or other safety findings at the Screening Visit that indicate a potential risk for the participant if enrolled, in the opinion of the investigator.
  • The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.

Part C Only:

  • The participant has received at least one dose of Lu AG13909 in Part A or Part B.

Other inclusion and exclusion criteria may apply.

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lu AG13909

Participants in Part A will receive multiple intravenous (IV) doses of Lu AG13909 per a prespecified dosing schedule. After data from Part A has shown that a pharmacologically relevant dose level is safe and tolerable, participants in Part B will then receive multiple IV doses of Lu AG13909 per a prespecified dosing schedule. After data from Part B has shown that a pharmacologically relevant dose level is safe and tolerable, participants in Part C will then receive multiple IV doses of Lu AG13909 per a prespecified dosing schedule. Participants from Part C may be eligible to continue in the optional Treatment Extension.

Interventions

Lu AG13909

Solution for infusion

Primary outcome measure

  • Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 161 ]
  • Parts A and B: Number of Participants With Anti-Drug Antibodies (ADAs) [ Time Frame: Day 1 up to Day 161 ]
  • Parts A and B: Cmax: Maximum Observed Serum Concentration of Lu AG13909 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Baseline up to Day 85 ]
  • Parts A and B: AUC0-tau: Area under the curve over a dosing interval [ Time Frame: 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) [ Time Frame: Day 169 ]

Central Contacts and Locations

Central contacts

Email contact via H. Lundbeck A/S

+45 36301311HQ_Medinfo@Lundbeck.com

Locations

University Hospital-University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

More Information

Sponsor

H. Lundbeck A/S

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lundbeck A/S on 2026-03-09.