Adrenal Hyperplasia, CongenitalPhase 2NCT07859293
An Extension Trial of Asedebart in Participants With Congenital Adrenal Hyperplasia
A Phase 2 study testing Asedebart in people with Adrenal Hyperplasia, Congenital, run by H. Lundbeck A/S.
Trial summary
The main goal of the trial is to study the long-term safety, how well people can handle the treatment, and how asedebart acts in the body and affects the body when used to treat classic congenital adrenal hyperplasia (CAH). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adrenal Hyperplasia, Congenital
- What is being tested?
- Asedebart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Jul 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant has been treated with asedebart in a clinical trial.
- The participant had an acceptable benefit-risk assessment in the prior trial and would benefit from continued treatment with asedebart in the opinion of the investigator.
- For participants with > 12 weeks since their last dose of asedebart: The participant has been on a stable daily dose of GC replacement therapy of ≥ 8 milligram per square meter (mg/m^2) (adjusted for body surface area in hydrocortisone equivalent dosage [HCe]) for >= 1 month prior to the Screening Visit.
- For participants with > 12 weeks since their last dose of asedebart: The participant is not adequately controlled on their current treatment and, at the Screening/Baseline Visit, has either:
- elevated androgen blood concentrations (A4 > upper limit of normal (ULN) for age and sex) in morning measurements (pre-GC replacement dose) OR
- androgen blood concentrations within the reference range (A4 <= ULN for age and sex) and is being treated with supraphysiological GC (GC daily dose > 13 mg/m^2 adjusted for body surface area in HCe)
Who cannot join
- The participant has known hypersensitivity or intolerance to asedebart or its excipients.
- The participant has taken any investigational medicinal product (IMP) other than asedebart < 3 months or < 5 half-lives, whichever is longer, prior to the first dose of asedebart in this trial.
- The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
- The participant has an increased risk of adrenal crisis in the opinion of the investigator (for example history of repeated adrenal crisis in recent years, history of adrenal crisis caused by reduction of GC dose).
- Other protocol-defined criteria apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Interventional, Open-label, Extension Trial of Asedebart (Lu AG13909) in Participants With Congenital Adrenal Hyperplasia
The main goal of the trial is to study the long-term safety, how well people can handle the treatment, and how asedebart acts in the body and affects the body when used to treat classic congenital adrenal hyperplasia (CAH). The trial will include participants who have previously received asedebart in trial 19873A (NCT05669950).
- Conditions
- Adrenal Hyperplasia, Congenital
- Being tested
- Asedebart
- Keywords
- CAH, asedebart, Lu AG13909
- Medical subject headings
- Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsedebartDrug
Also called Lu AG13909
Solution for injection/infusion
| Study group | Role | What they receive |
|---|---|---|
| Asedebart | Experimental | Participants will receive asedebart per a prespecified dosing schedule. Receives: Drug: Asedebart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 42 months
Secondary outcomes (11)
Serum Concentration of Asedebart
Measured: Up to 42 months
Area Under the Asedebart Serum Concentration-time Curve in a Dosing Interval (AUC0-tau)
Measured: Up to 73 days
Area Under the Asedebart Serum Concentration-time Curve From Start of Injection to 28 days Post-dose (AUC0-4W)
Measured: Up to 73 days
Maximum Observed Serum Concentration of Asedebart (Cmax)
Measured: Up to 73 days
Nominal Time Corresponding to the Occurrence of Cmax of Asedebart (Tmax)
Measured: Up to 73 days
Minimum Observed Serum Concentration of Asedebart (Ctrough)
Measured: Up to 73 days
Nominal Time Corresponding to the Occurrence of Ctrough (Ttrough)
Measured: Up to 73 days
Number of Participants with Anti-drug Antibodies (ADAs) Following Dosing
Measured: Up to 42 months
Relative Reduction from Baseline in Morning Concentrations of Androstenedione (A4) in Blood
Measured: Baseline, Month 12, 24, and 36
Relative Reduction from Baseline in Morning Concentrations of 17-hydroxyprogesterone (17-OHP) in Blood
Measured: Baseline, Month 12, 24, and 36
Relative Reduction from Baseline in Morning Concentrations of Glucocorticoid (GC) Daily Dose
Measured: Baseline, Month 12, 24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jul 2031 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal Hyperplasia, CongenitalStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The trial will begin with a pharmacokinetic (PK) Period, which will include participants in Cohort 1. Following completion of the PK Period, participants in Cohort 1 will continue their trial participation in the Main Treatment Period. Participants in Cohorts 2 and 3 will enter the trial in the Main Treatment Period. All participants will attend the Completion Visit after last study drug administration.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859293
- Sponsor's protocol ID
- 21540A
- Other IDs
- 2026-525325-20-00
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Extension Trial of Asedebart (Lu AG13909) in Participants With Congenital Adrenal Hyperplasia
- ClinicalTrials.gov ID
- NCT07859293
- Acronym / sponsor ID
- 21540A
- Conditions
- Adrenal Hyperplasia, Congenital
- Keywords
- CAH, asedebart, Lu AG13909
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of the trial is to study the long-term safety, how well people can handle the treatment, and how asedebart acts in the body and affects the body when used to treat classic congenital adrenal hyperplasia (CAH). The trial will include participants who have previously received asedebart in trial 19873A (NCT05669950).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The trial will begin with a pharmacokinetic (PK) Period, which will include participants in Cohort 1. Following completion of the PK Period, participants in Cohort 1 will continue their trial participation in the Main Treatment Period. Participants in Cohorts 2 and 3 will enter the trial in the Main Treatment Period. All participants will attend the Completion Visit after last study drug administration.
| Arm | Type | Receives |
|---|---|---|
| Asedebart | Experimental | Drug: AsedebartParticipants will receive asedebart per a prespecified dosing schedule. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The participant has been treated with asedebart in a clinical trial.
- The participant had an acceptable benefit-risk assessment in the prior trial and would benefit from continued treatment with asedebart in the opinion of the investigator.
- For participants with > 12 weeks since their last dose of asedebart: The participant has been on a stable daily dose of GC replacement therapy of ≥ 8 milligram per square meter (mg/m^2) (adjusted for body surface area in hydrocortisone equivalent dosage [HCe]) for >= 1 month prior to the Screening Visit.
- For participants with > 12 weeks since their last dose of asedebart: The participant is not adequately controlled on their current treatment and, at the Screening/Baseline Visit, has either:
Key exclusion criteria (5 listed)
- The participant has known hypersensitivity or intolerance to asedebart or its excipients.
- The participant has taken any investigational medicinal product (IMP) other than asedebart < 3 months or < 5 half-lives, whichever is longer, prior to the first dose of asedebart in this trial.
- The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
- The participant has an increased risk of adrenal crisis in the opinion of the investigator (for example history of repeated adrenal crisis in recent years, history of adrenal crisis caused by reduction of GC dose).
- Other protocol-defined criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsedebartAlso: Lu AG13909Solution for injection/infusion | Drug | Asedebart |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 42 months
11 secondary outcomes
Serum Concentration of Asedebart
Time frame: Up to 42 months
Area Under the Asedebart Serum Concentration-time Curve in a Dosing Interval (AUC0-tau)
Time frame: Up to 73 days
Area Under the Asedebart Serum Concentration-time Curve From Start of Injection to 28 days Post-dose (AUC0-4W)
Time frame: Up to 73 days
Maximum Observed Serum Concentration of Asedebart (Cmax)
Time frame: Up to 73 days
Nominal Time Corresponding to the Occurrence of Cmax of Asedebart (Tmax)
Time frame: Up to 73 days
Minimum Observed Serum Concentration of Asedebart (Ctrough)
Time frame: Up to 73 days
Nominal Time Corresponding to the Occurrence of Ctrough (Ttrough)
Time frame: Up to 73 days
Number of Participants with Anti-drug Antibodies (ADAs) Following Dosing
Time frame: Up to 42 months
Relative Reduction from Baseline in Morning Concentrations of Androstenedione (A4) in Blood
Time frame: Baseline, Month 12, 24, and 36
Relative Reduction from Baseline in Morning Concentrations of 17-hydroxyprogesterone (17-OHP) in Blood
Time frame: Baseline, Month 12, 24, and 36
Relative Reduction from Baseline in Morning Concentrations of Glucocorticoid (GC) Daily Dose
Time frame: Baseline, Month 12, 24, and 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Email contact via H. Lundbeck A/S study director
H. Lundbeck A/S
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asedebart in people with Adrenal Hyperplasia, Congenital, run by H. Lundbeck A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Email contact via H. Lundbeck A/S (+45 36301311, HQ_Medinfo@Lundbeck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.