RecruitingPhase 3NCT07144163
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants With Classic Congenital Adrenal Hyperplasia (Calm-CAH)
Sponsor
Crinetics Pharmaceuticals Inc.
Enrollment
150 participants
Start Date
Dec 11, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 74 Years
Inclusion Criteria10
- 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:
- A4 >ULN and treated with <11 mg/m2/day (physiologic) GC doses
- OR normal A4 (>0.5xULN to ≤1xULN) and treated with ≥14 mg/m2/day GC doses
- OR A4 >ULN and treated with ≥11 mg/m2/day GC doses.
- 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 Criteria10
- Diagnosis of any form of CAH other than classic 21-OHD.
- History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.
- 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.
- Severe erythrocytosis as judged by the Investigator.
- Use of atumelnant prior to screening.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGAtumelnant
Atumelnant, tablets, once daily by mouth
DRUGPlacebo
Placebo, tablets, once daily by mouth
Locations(36)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07144163
Related Trials
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
NCT0715984132 locations
Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old
NCT071873753 locations
A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
NCT0566995017 locations
Institutional Registry of Rare Diseases
NCT065737231 location
An Extension Study to Evaluate Safety and Efficacy in Participants Treated With CRN04894
NCT067128239 locations