Clinical Trials in the UK / NCT05669950
Recruiting
Phase 1/2
A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
NCT05669950 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Congenital Adrenal Hyperplasia
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — Up to Day 161
- Parts A and B: Number of Participants With Anti-Drug Antibodies (ADAs) — Day 1 up to Day 161
- Parts A and B: Cmax: Maximum Observed Serum Concentration of Lu AG13909 — 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 — 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 — 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 — 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 — 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 — 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 — 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) — Baseline up to Day 85
- Parts A and B: AUC0-tau: Area under the curve over a dosing interval — 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) — Day 169
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital-University of Michigan | Ann Arbor | Michigan | Recruiting |
| Rigshospitalet | Copenhagen | Denmark | Recruiting |
| Chu Angers | Angers | France | Recruiting |
| CHU de Lille | Lille | France | Recruiting |
| GH Pitié-Salpêtrière | Paris | France | Recruiting |
| CHRU Strasbourg | Strasbourg | France | Recruiting |
| David Metreveli Medical Centre, Tbilisi | Tbilisi | Georgia | Recruiting |
| Beaumont Hospital Royal College of Surgeons in Ireland (RCSI), Dublin | Dublin | Ireland | Recruiting |
| Azienda Ospedaliero Universitaria di Bologna | Bologna | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma | Roma | Italy | Recruiting |
| Centrum Nowoczesnych Terapii, Dobry Lekarz | Dobry Lekarz | Poland | Recruiting |
| Sahlgrenska University Hospital | Gothenburg | Sweden | Recruiting |
| Karolinska University Hospital | Stockholm | Sweden | Recruiting |
| NIHR/Wellcome Trust Clinical Research Facility | Birmingham | United Kingdom | Recruiting |
| Cambridge Clinical Research Centre | Cambridge | United Kingdom | Recruiting |
| NIHR Clinical Research Facility | London | United Kingdom | Recruiting |
| University College London Hospital - NIHR | London | United Kingdom | Recruiting |
More H. Lundbeck A/S trials in the UK
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A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)
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Other trials for the same condition
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05669950 on ClinicalTrials.gov ↗ ← All trials in the UK