RecruitingPHASE1, PHASE2INTERVENTIONAL

A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia

This research is testing a new medication called Lu AG13909 for adults who have a rare genetic condition called Congenital Adrenal Hyperplasia (CAH). CAH affects how your body makes certain important hormones. The main goals of this study are to understand if Lu AG13909 is safe and well-tolerated by the body, how it moves through the body, and how the body reacts to it. Researchers will be giving participants different doses of the medication to see what effects it has. This is an early-stage study, combining Phase 1 and Phase 2, which means it's one of the first times this medicine is being tested in people with CAH, helping gather important information for its potential future development.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

H. Lundbeck A/S

Enrolment target

Start

19 Dec 2022

Estimated completion

31 Dec 2027

Congenital Adrenal Hyperplasia

What is this study about?

This study is investigating a new medicine, called Lu AG13909, for adults who have Congenital Adrenal Hyperplasia (CAH). CAH is a rare health condition that someone is born with, which affects how their body produces important hormones. These hormones usually help manage things like stress and growth, so people with CAH often need to take other medicines to help balance their hormone levels.

The main reasons for doing this study are to find out if Lu AG13909 is safe for people to take and if their bodies can handle it well. Researchers also want to learn how the medicine behaves once it's in the body – for example, how it's absorbed and broken down. Finally, they will be looking at how the body responds to different amounts (doses) of Lu AG13909.

By taking part, you would be helping doctors and scientists better understand CAH and explore new ways to manage it. This study is an important step in researching potential new treatments for this condition.

Key takeaways

This study is for adults with a specific type of CAH.
It's testing a new medicine called Lu AG13909.
The main goals are to check safety, how the body handles the medicine, and how different doses affect the body.
You must be 18-70 years old and meet specific health criteria to take part.
Participation involves regular clinic visits, blood tests, and health monitoring.
You can withdraw from the study at any time without affecting your usual medical care.

Who may be eligible?

To join this study, you must be an adult between 18 and 70 years old and have a confirmed diagnosis of a specific type of CAH (called 21-hydroxylase deficiency). You'll also need to have certain hormone levels in your blood checked, and your overall health, apart from CAH, should be good in the opinion of the study doctor. You must also have been taking your usual CAH medicines (like glucocorticoids, and mineralocorticoids if you have the "salt-wasting" type) at a steady dose for a period before the study starts.

There are also a few reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you won't be able to take part. Also, if you've had a bad reaction to Lu AG13909 or similar medicines before, or if other health test results show it might be risky for you to join, then leider, sadly, you wouldn't be suitable for this study. The study doctors will carefully review your health information to make sure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged between 18 and 70?
Do you have a confirmed diagnosis of 21-hydroxylase deficiency CAH?
Have you been taking your usual CAH medicines (like glucocorticoids) at a steady dose for at least a month?
Are you generally healthy, apart from your CAH, according to your doctor?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given the study medicine, Lu AG13909, at different doses. You'll have regular hospital visits for various checks. These checks will include blood tests to measure your hormone levels and see how the medicine is working, and possibly how it moves through your body. You'll also have physical examinations, vital signs taken (like blood pressure and heart rate), and ECGs (heart tracings) to monitor your overall health and safety.

The study will involve several visits to the clinic over a period, which the study team will explain in detail. You will continue to take your regular CAH medications unless otherwise advised by the study doctor. There will also be follow-up appointments after you stop taking the study medicine to ensure everything is well. The total duration for each participant will be clearly outlined by the study team.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from receiving a new investigational treatment that could help manage your CAH, and you will contribute important knowledge to the medical community. However, there's a chance the medicine might not work for you, or you could experience side effects. These side effects can range from mild to serious, and the study team will monitor you closely for any changes. You will be given a complete list of known potential side effects during the consent process. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (17)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital-University of Michigan
Verified postcode
Ann Arbor, United States· Recruiting
Rigshospitalet
Verified postcode
Copenhagen, Denmark· Recruiting
Chu Angers
Verified postcode
Angers, France· Recruiting
CHU de Lille
Verified postcode
Lille, France· Recruiting
GH Pitié-Salpêtrière
Verified postcode
Paris, France· Recruiting
CHRU Strasbourg
Verified postcode
Strasbourg, France· Recruiting
David Metreveli Medical Centre, Tbilisi
Verified postcode
Tbilisi, Georgia· Recruiting
Beaumont Hospital Royal College of Surgeons in Ireland (RCSI), Dublin
Verified postcode
Dublin, Ireland· Recruiting
Azienda Ospedaliero Universitaria di Bologna
Verified postcode
Bologna, Italy· Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma
Verified postcode
Roma, Italy· Recruiting
Centrum Nowoczesnych Terapii, Dobry Lekarz
Unverified
Dobry Lekarz, Poland· Recruiting
Sahlgrenska University Hospital
Verified postcode
Gothenburg, Sweden· Recruiting

Common questions

What is Congenital Adrenal Hyperplasia (CAH)?

CAH is a genetic condition present from birth where your body has trouble making enough of certain hormones like cortisol, which are important for managing stress and other body functions.

What is Lu AG13909?

Lu AG13909 is the name of the new investigational medicine being tested in this study. It's not yet approved for general use but is being researched as a potential treatment for CAH.

Why is this study important?

This study is important because it helps scientists learn more about CAH and explore new ways to treat it, potentially leading to better management options for people with the condition in the future.

Will I know if I'm getting the active medicine or a placebo (dummy medicine)?

In some studies, participants don't know whether they are receiving the active medicine. The study team will explain how this study is designed in detail, including whether a placebo is involved and who will know what.

Can I continue my regular CAH medicines during the study?

Yes, generally you will continue your usual CAH medicines (like glucocorticoids and mineralocorticoids) at their stable doses, unless the study doctor provides specific instructions otherwise.

How to find out more

Email contact via H. Lundbeck A/S

HQ_Medinfo@Lundbeck.com +45 36301311 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.