The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of atumelnant (CRN04894) in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.
This Phase 2, open-label, sequential dose cohort study will evaluate the efficacy, safety, PK, and PD of atumelnant (CRN04894) when administered for 12 weeks in participants with CAH caused by 21-hydroxylase deficiency. Up to 42 participants will be enrolled in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.
Crinetics Study Site
Pasadena, California, United States
Change from baseline in morning (before 11:00) serum androstenedione (A4)
Time frame: Week 12
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Time frame: Week 12
Change from baseline in morning (before 11:00) serum 17-hydroxyprogesterone (17-OHP)
Time frame: Week 12
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Crinetics Study Site
Ann Arbor, Michigan, United States
Crinetics Study Site
Minneapolis, Minnesota, United States
Crinetics Study Site
St Louis, Missouri, United States
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Morehead City, North Carolina, United States
Crinetics Study Site
Cleveland, Ohio, United States
Crinetics Study Site
Philadelphia, Pennsylvania, United States
Crinetics Study Site
East Providence, Rhode Island, United States
Crinetics Study Site
Córdoba, Córdoba Province, Argentina
Crinetics Study Site
Buenos Aires, Argentina
...and 17 more locations