At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- atumelnant (CRN04894) (drug)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- atumelnant (CRN04894) — drug: Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist.
- Patient visit burden
- Not specified by the sponsor
In plain English
This extension study looks at the safety and how well atumelnant works in people with congenital adrenal hyperplasia (CAH), a condition the body makes too little of certain hormones. It is run by Crinetics Pharmaceuticals Inc. It is only open to people who have already finished the treatment period of an earlier Crinetics atumelnant CAH study.
Who can take part
- People with CAH who finished the treatment period of an earlier Crinetics atumelnant study, and where the study doctor believes they benefited and would benefit from continuing the medicine
- The study includes two groups: people who did not stop taking the study medicine between the end of the earlier study and the start of this one (Group 1), and people who did have a break in the medicine (Group 2)
- Women who can become pregnant must use highly effective contraception, or be unable to have children (for example through surgery or after the menopause)
- Men must use a condom with a female partner who can become pregnant, or be surgically sterile or long-term abstinent, and must not donate sperm during the study and for at least 2 weeks after the last dose
- Willing and able to give consent and follow the study instructions and treatment
Who may not be able to
- Any health problem or test result that, in the study doctor's view, could put the person's safety at risk or stop them finishing the study
- Alcohol or drug misuse now or in the past 12 months
- A mental health condition that means the person cannot understand the study, or a history of not following medical instructions
- Known allergy or bad reaction to the study medicine or related substances, or being at high risk of adrenal insufficiency (the adrenal glands not making enough hormones), as judged by the study doctor
- Women who are pregnant or breastfeeding, or people unwilling to use contraception as described
- Employees of Crinetics or their close family
- Taking another investigational (experimental) drug within 60 days or 5 half-lives (whichever is longer) before joining, or planning to join another study
- Cancer within the last 5 years, apart from some fully treated skin or cervical cancers
- Being held in an institution by court or official order
- For people not currently taking atumelnant: significant abnormal test results or other serious conditions such as heart disease, severe kidney problems, or serious liver disease
- For people not currently taking atumelnant: past removal of both adrenal glands, hypopituitarism (the pituitary gland not working properly), or any other condition needing long-term steroid treatment
- For people not currently taking atumelnant: major surgery within 4 weeks before screening
- For people not currently taking atumelnant: poorly controlled diabetes (HbA1c of 8.5% or higher)
- For people not currently taking atumelnant: an underactive thyroid not properly treated
- For people not currently taking atumelnant: certain abnormal heart rhythm test results at screening
What taking part involves
- • Taking atumelnant, the same study medicine as in the earlier parent study
- • Continuing treatment as part of an open-label extension (everyone receives the study medicine)
Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what tests or checks are involved.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 16 Years to 74 Years
- Who
- All
- Number of participants
- 200
- Started
- 2025-02-25
- Last checked
- 2025-06
Plain English Summary
What is this study?
- • Testing a new treatment for congenital adrenal hyperplasia
- • Phase2 - 200 participants
- • The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894)
Who can take part?
- • Ages 16 Years to 74 Years
- • Diagnosed with congenital adrenal hyperplasia
Where?
- • Birmingham - Crinetics Study Site
- • London - Crinetics Study Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).
More detail
This single-arm, long-term, open-label, study is designed to evaluate the safety, tolerability, and efficacy of atumelnant (CRN04894) in participants with congenital adrenal hyperplasia (CAH). Enrollment will be limited to individuals who completed a parent Crinetics atumelnant CAH study, and in the opinion of the Investigator had an acceptable benefit-risk assessment in the completed study and would benefit from continued dosing in this Open-Label Extension (OLE) study. A total of approximately 150 - 200 participants may be enrolled in the study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years - 74 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ with 2 follicle-stimulating hormone (FSH) measurements
What the study is looking for
- ✓Participants are eligible to be included in the study only if all the following criteria apply:
- ✓Group 1: Participants meeting the above criteria and did not have the study treatment administration interrupted between End...
- ✓Group 2: Participants meeting the above criteria but had the study treatment administration interrupted between EOT of the...
- ✓Female participants who engage in heterosexual intercourse must:
- ✓Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy for...
Who cannot take part
- ✗Participants are excluded from the study if any of the following criteria apply:
- ✗Any medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the...
- ✗Participants have known history of (that is within the past 12 months), or current alcohol or drug abuse.
- ✗Participants have any mental condition rendering him/her unable to understand the nature, scope, and possible...
- ✗Participants have a known allergy or hypersensitivity to any of the test materials or related compounds, including...
See the full criteria
Where Is This Study? (2 UK sites)
Crinetics Study Site
Birmingham CV22DX, United Kingdom
Crinetics Study Site
London NW1 2BU, United Kingdom
How to Get in Touch
Crinetics Clinical Trials
Sponsor contactCONTACT
