A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia (NCT07144163) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
United States, Argentina, Australia150 participantsStarted 2025-12-11
Plain-language summary
The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, between ≥18 to \<75 years of age at the time of signing the ICF.
. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
. Have classic CAH due to 21-OHD confirmed by the Investigator.
. Participants with Visit 2 levels of morning serum A4 as follows:
. On a stable (defined as no dose change of \>5 mg/day hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (e.g., hydrocortisone, prednisolone, prednisone, methylprednisolone, meprednisone, dexamethasone, cortisone acetate) at the time of informed consent.
. If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range.
. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.
Exclusion criteria
. Diagnosis of any form of CAH other than classic 21-OHD.
. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement.
. Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.
. Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions.
. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
. Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.
. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.
. Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.