Evaluating Lu AG13909 for treating congenital adrenal hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effects of varying doses of Lu AG13909 in adults diagnosed with congenital adrenal hyperplasia (CAH), a rare genetic disorder affecting hormone production. The study aims to assess the safety, tolerability, and pharmacokinetics of Lu AG13909, as well as the body's response to the treatment. Participants will be monitored for their hormone levels and overall health during the trial. The study is divided into phases to ensure thorough evaluation of the drug's effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital-University of Michigan
  Ann Arbor, Michigan, United States 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

Study contacts

• Study coordinator: Email contact via H. Lundbeck A/S
• Email: HQ_Medinfo@Lundbeck.com
• Phone: +45 36301311

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Crinecerfont safety testing in babies with classic CAH under 4 years old

  This study tests whether crinecerfont is safe and tolerable in children under 4 years with classic CAH who have been on hydrocortisone.

  Recruiting at 11 sites Phase 2 Neurocrine Biosciences · San Francisco, California and 10 other locations · NCT07536269

• Atumelnant for children with classic congenital adrenal hyperplasia (Balance-CAH)

  This study will test whether atumelnant is safe and helps control hormone levels in children aged 1 to under 18 with classic congenital adrenal hyperplasia.

  Recruiting at 50 sites Phase 2/3 Crinetics Pharmaceuticals Inc. · Los Angeles, California and 52 other locations · NCT07159841

• Atumelnant for adults with classic congenital adrenal hyperplasia

  This will test whether taking once-daily atumelnant helps adults with classic 21‑hydroxylase deficiency CAH who are already on stable glucocorticoid therapy.

  Recruiting at 82 sites Phase 3 Crinetics Pharmaceuticals Inc. · Los Angeles, California and 81 other locations · NCT07144163

• Registry for male patients with congenital adrenal hyperplasia

  This study is creating a registry for boys with congenital adrenal hyperplasia to better understand the condition and track how common it is in the Emilia Romagna region.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna · NCT06754423

• Long-term evaluation of atumelnant for congenital adrenal hyperplasia

  This study is testing if a new treatment called atumelnant is safe and effective for people with congenital adrenal hyperplasia who have already participated in a related study.

  Recruiting at 10 sites Phase 2 Crinetics Pharmaceuticals Inc. · Minneapolis, Minnesota and 12 other locations · NCT06712823

• Registry for Rare Diseases

  This study is creating a detailed registry to collect information on rare diseases like amyloidosis and sarcoidosis to help improve how they are diagnosed and treated.

  Recruiting Hospital Italiano de Buenos Aires · Buenos Aires, Buenos Aires · NCT06573723

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.