A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
In brief
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.
Key facts
- Study ID
- NCT07144163
- Run by
- Crinetics Pharmaceuticals Inc.
- People needed
- 150
- Starts
- 2025-12-11
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Crinetics Study Site — Atlanta, Georgia, United States (enrolling)
- Crinetics Study Site — Chicago, Illinois, United States (enrolling)
- Crinetics Study Site — Baltimore, Maryland, United States (enrolling)
- Crinetics Study Site — Ann Arbor, Michigan, United States (enrolling)
- Crinetics Study Site — Minneapolis, Minnesota, United States (enrolling)
- Crinetics Study Site — Rochester, Minnesota, United States (enrolling)
- Crinetics Study Site — Pittsburgh, Pennsylvania, United States (enrolling)
- Crinetics Study Site — Dallas, Texas, United States (enrolling)
- Crinetics Study Site — Milwaukee, Wisconsin, United States (enrolling)
- Crinetics Study Site — Buenos Aires, Buenos Aires F.D., Argentina (enrolling)
- Crinetics Study Site — Buenos Aires, Buenos Aires F.D., Argentina (enrolling)
- Crinetics Study Site — CABA, Buenos Aires F.D., Argentina (enrolling)
- Crinetics Study Site — CABA, Buenos Aires F.D., Argentina (enrolling)
- Crinetics Study Site — Córdoba, Córdoba Province, Argentina (enrolling)
- Crinetics Study Site — Herston, Queensland, Australia (enrolling)
- Crinetics Study Site — Woolloongabba, Queensland, Australia (enrolling)
- Crinetics Study Site — Adelaide, South Australia, Australia (enrolling)
- Crinetics Study Site — Parkville, Victoria, Australia (enrolling)
- Crinetics Study Site — Nedlands, Western Australia, Australia (enrolling)
- Crinetics Study Site — Vienna, Austria (enrolling)
- Crinetics Study Site — Fortaleza, Ceará, Brazil (enrolling)
- Crinetics Study Site — Curitiba, Paraná, Brazil (enrolling)
- Crinetics Study Site — Rio de Janeiro, Rio de Janeiro, Brazil (enrolling)
- Crinetics Study Site — Rio de Janeiro, Rio de Janeiro, Brazil (enrolling)
- Crinetics Study Site — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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