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A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Led by Crinetics Pharmaceuticals Inc. · Updated on 2026-04-30
150
Participants Needed
26
Research Sites
72 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 to under 75 years at consent
- Willing and able to follow study procedures and treatment
- Confirmed classic CAH due to 21-hydroxylase deficiency
- Morning serum androstenedione (A4) levels meeting specified criteria with corresponding glucocorticoid doses
- Stable glucocorticoid replacement regimen with no dose changes >5 mg/day hydrocortisone equivalent within 2 months prior to screening
- Stable mineralocorticoid dose for at least 1 month prior to screening with normal serum sodium and potassium and no orthostatic hypotension
- Stable estrogen therapy dose for at least 3 months prior to screening if applicable
You will not qualify if you...
- Diagnosis of any CAH form other than classic 21-hydroxylase deficiency
- History of bilateral adrenalectomy, hypopituitarism, or other chronic glucocorticoid-requiring conditions
- Significant medical conditions or abnormal lab tests unrelated to CAH as judged by the investigator
- Mental conditions impairing understanding or compliance
- History of cancer except treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ
- Pregnancy, lactation, or unwillingness to use effective contraception if of childbearing potential
- Known hypersensitivity to atumelnant or its ingredients
- Increased risk for adrenal insufficiency as judged by the investigator
- Severe erythrocytosis as judged by the investigator
- Prior use of atumelnant before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Crinetics Study Site
Chicago, Illinois, United States, 60611
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2
Crinetics Study Site
Ann Arbor, Michigan, United States, 48109
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3
Crinetics Study Site
Rochester, Minnesota, United States, 55905
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4
Crinetics Study Site
Buenos Aires, Buenos Aires F.D., Argentina, 1405
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5
Crinetics Study Site
Buenos Aires, Buenos Aires F.D., Argentina, C1012AAR
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6
Crinetics Study Site
CABA, Buenos Aires F.D., Argentina, C1199ABB
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7
Crinetics Study Site
Córdoba, Córdoba Province, Argentina, X5000JRD
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8
Crinetics Study Site
Herston, Queensland, Australia, 4029
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9
Crinetics Study Site
Woolloongabba, Queensland, Australia, 4102
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10
Crinetics Study Site
Adelaide, South Australia, Australia, 5000
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11
Crinetics Study Site
Parkville, Victoria, Australia, 3050
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12
Crinetics Study Site
Nedlands, Western Australia, Australia, 6009
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13
Crinetics Study Site
Curitiba, Paraná, Brazil, 33172
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14
Crinetics Study Site
Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
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15
Crinetics Study Site
Botucatu, São Paulo, Brazil, 18618-686
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16
Crinetics Study Site
São Paulo, São Paulo, Brazil, 04024-002
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17
Crinetics Study Site
São Paulo, São Paulo, Brazil, 05403-000
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18
Crinetics Study Site
Angers, France, 49933
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19
Crinetics Study Site
Bron, France, 69500
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20
Crinetics Study Site
Nantes, France, 44093 Cedex 1
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21
Crinetics Study Site
Pessac, France, 33604
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22
Crinetics Study Site
Vandœuvre-lès-Nancy, France, 54500
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23
Crinetics Study Site
Munich, Bavaria, Germany, 80336
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24
Crinetics Study Site
Würzburg, Germany, 97080
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25
Crinetics Study Site
Milan, Milano, Italy, 20149
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26
Crinetics Study Site
Warsaw, Masovian Voivodeship, Poland, 00-189
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Research Team
C
Crinetics Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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