Health TrialsbyHealthPanel

A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

ConditionCongenital Adrenal Hyperplasia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorH. Lundbeck A/S

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 (m²) (minimum 50 kg) and ≤40 kg/m².

Stable GC replacement therapy for ≥1 month prior to the Screening Visit.

Disqualifiers

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.

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Lu AG13909

    Drug

    Solution for infusion

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Lu AG13909Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to Day 161
2

Parts A and B: Number of Participants With Anti-Drug Antibodies (ADAs)

Time frame
Day 1 up to Day 161
3

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
4

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

Secondary outcomes

1

Part C: Lu AG13909 Serum Concentrations Following Multiple IV Doses

Time frame
Baseline up to Day 352
2

Part C: Change From Baseline of Lu AG13909 in Blood Concentrations of 17-OHP and A4

Time frame
Baseline up to Day 169
3

Part C: Number of Participants With TEAEs

Time frame
Baseline up to Day 352
4

Part C: Number of Participants With ADAs

Time frame
Baseline up to Day 352

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lundbeck A/S

Lead sponsor

Source ClinicalTrials.gov
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