A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
This study is looking into a new medicine called atumelnant for adults aged 18 to 74 who have a specific type of congenital adrenal hyperplasia (CAH). CAH is a condition where the body doesn't produce enough of certain hormones. The main goal is to find out if atumelnant is effective and safe. Participants will take either the study medicine or a dummy pill (placebo) once a day. The study will also help us understand how the medicine works in the body. It’s for people who are already on stable treatment for CAH. This is a crucial step in potentially finding new ways to manage CAH.
At a glance
What is this study about?
This study is exploring a new medicine called atumelnant. It’s being tested in adults who have a specific form of a condition known as congenital adrenal hyperplasia, or CAH for short. CAH is a lifelong condition where the adrenal glands, which sit above your kidneys, don't make enough of certain important hormones. This type of CAH is caused by a problem with an enzyme called 21-OHD.
The main purpose of this study is to see if atumelnant can help manage the symptoms of CAH and improve how people feel. Researchers also want to make sure the medicine is safe and understand how it works in the body. If successful, this new medicine could offer another option for people living with CAH, potentially helping to reduce their reliance on current treatments which can sometimes have side effects.
Taking part in a study like this is a chance to contribute to medical knowledge and potentially help others with the same condition in the future. The study is run as a 'Phase 3' trial, which means it’s one of the final steps before a medicine might be made widely available, assuming it proves to be safe and effective.
Key takeaways
- This study is for adults (18-74) with a specific type of CAH.
- It's testing a new medicine called atumelnant against a dummy pill.
- The goal is to check safety and how well atumelnant works.
- Participants must be on stable current CAH medication.
- Your health will be closely monitored during the study.
Who may be eligible?
To join this study, you need to be an adult between 18 and 74 years old. You must have a specific type of congenital adrenal hyperplasia (CAH) that affects the 21-hydroxylase enzyme, and your doctor must confirm this. You also need to be willing and able to follow the study's instructions carefully.
Important medical requirements include being on a steady dose of your usual steroid medicine (like hydrocortisone or prednisolone) for at least two months before the study starts. If you take other hormone medicines, like fludrocortisone or estrogen, those doses also need to have been stable for a certain period. The study will check your hormone levels to see if they fit the criteria.
However, you won't be able to join if you have other types of CAH, or if you've had surgery on both your adrenal glands. Also, if you have other serious medical conditions, a history of certain cancers, or if you are pregnant, breastfeeding, or unable to use reliable contraception (if needed), you won't be able 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 between 18 and 74 years old?
- Has your doctor confirmed you have 'classic CAH due to 21-OHD'?
- Have you been on a stable dose of your steroid medicine for at least the last two months?
- Are you willing and able to follow the study instructions?
What does participation involve?
If you decide to take part, you'll first have a screening period lasting 3 to 6 weeks. During this time, the study team will carry out checks to make sure you're suitable for the study. If you are, you'll then be randomly assigned to receive either the new medicine, atumelnant, or a dummy pill (placebo). You'll have a 2 out of 3 chance of receiving the active medicine.
You'll take one pill once a day. For those on atumelnant, there might be an option to increase the dose after about 20 weeks. You'll have regular visits to the study clinic for checks, blood tests, and to discuss how you're feeling. The study team will provide all the necessary medication and guidance. The total duration of your participation will be outlined by the study team.
Potential risks and benefits
Locations (45)
- Crinetics Study SiteVerified postcodeLos Angeles, United States· Recruiting
- Crinetics Study SiteVerified postcodeAtlanta, United States· Recruiting
- Crinetics Study SiteVerified postcodeChicago, United States· Recruiting
- Crinetics Study SiteVerified postcodeAnn Arbor, United States· Recruiting
- Crinetics Study SiteVerified postcodeMinneapolis, United States· Recruiting
- Crinetics Study SiteVerified postcodeRochester, United States· Recruiting
- Crinetics Study SiteVerified postcodePittsburgh, United States· Recruiting
- Crinetics Study SiteVerified postcodeDallas, United States· Recruiting
- Crinetics Study SiteVerified postcodeMilwaukee, United States· Recruiting
- Crinetics Study SiteVerified postcodeBuenos Aires, Argentina· Recruiting
- Crinetics Study SiteVerified postcodeBuenos Aires, Argentina· Recruiting
- Crinetics Study SiteUnverifiedCABA, Argentina· Recruiting
Common questions
What is CAH?
CAH (Congenital Adrenal Hyperplasia) is a condition where your body's adrenal glands don't make enough of certain important hormones.
What is 'atumelnant'?
Atumelnant is the new medicine being tested in this study to see if it helps people with CAH.
Will I definitely get the new medicine?
No, you'll be randomly assigned to either receive atumelnant or a dummy pill (placebo). There's a 2 out of 3 chance you'll get the active medicine.
How long will the study last for me?
There's an initial screening period of 3-6 weeks, followed by the main treatment period. The exact total duration will be explained by the study team.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any point, and it won't affect your regular medical care.
How to find out more
Crinetics Clinical Trials
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.