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New infusion drug hopes to tame rare hormone disorder

NCT ID NCT05669950

Disease control Sponsor: H. Lundbeck A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called Lu AG13909 in 42 adults with congenital adrenal hyperplasia (CAH), a rare genetic condition that disrupts hormone production. The study aims to check the drug's safety, how it moves through the body, and its effects on hormone levels. Participants receive multiple doses of the drug by infusion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lu AG13909 (given as an infusion)
What this could lead to
If successful, this could point toward a new treatment option for congenital adrenal hyperplasia, potentially reducing the need for high doses of steroid replacement therapy.
What could go wrong
This is an early-phase trial with only 42 participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to show benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency congenital adrenal hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital adrenal hyperplasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Azienda Ospedaliero Universitaria di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma

    RECRUITING

    Roma, 00161, Italy

  • Beaumont Hospital Royal College of Surgeons in Ireland (RCSI), Dublin

    RECRUITING

    Dublin, D02 YN77, Ireland

  • CHRU Strasbourg

    RECRUITING

    Strasbourg, 67091, France

  • CHU de Lille

    RECRUITING

    Lille, 59000, France

  • Cambridge Clinical Research Centre

    RECRUITING

    Cambridge, CB2 0SL, United Kingdom

  • Centrum Nowoczesnych Terapii, Dobry Lekarz

    RECRUITING

    Dobry Lekarz, 60-324, Poland

  • Chu Angers

    RECRUITING

    Angers, 49933, France

  • David Metreveli Medical Centre, Tbilisi

    RECRUITING

    Tbilisi, 0144, Georgia

  • GH Pitié-Salpêtrière

    RECRUITING

    Paris, 75013, France

  • Karolinska University Hospital

    RECRUITING

    Stockholm, 17174, Sweden

  • NIHR Clinical Research Facility

    RECRUITING

    London, SE1 9RT, United Kingdom

  • NIHR/Wellcome Trust Clinical Research Facility

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 413 45, Sweden

  • University College London Hospital - NIHR

    RECRUITING

    London, W1T 7HA, United Kingdom

  • University Hospital-University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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