Status:
RECRUITING
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Lead Sponsor:
Crinetics Pharmaceuticals Inc.
Conditions:
Congenital Adrenal Hyperplasia
Classic Congenital Adrenal Hyperplasia
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief 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.
Detailed Description
This is a Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study in adult participants (male or female age ≥18 to \<75 years) with classic CAH due to 21-OHD who have been on ...
Eligibility Criteria
Inclusion
- 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 and approved by the Medical Monitor.
- Participants with levels of morning serum A4 as follows:
- A4 \>ULN and treated with \<11 mg/m2/day (physiologic) GC doses
- OR normal A4 (above mid-range to ≤ULN) and treated with ≥15 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 2 months 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
- 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.
Key Trial Info
Start Date :
December 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07144163
Start Date
December 11 2025
End Date
May 1 2027
Last Update
December 17 2025
Active Locations (5)
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1
Crinetics Study Site
Herston, Queensland, Australia, 4029
2
Crinetics Study Site
Woolloongabba, Queensland, Australia, 4102
3
Crinetics Study Site
Adelaide, South Australia, Australia, 5000
4
Crinetics Study Site
Parkville, Victoria, Australia, 3050