Phase
Condition
Congenital Adrenal Hyperplasia
Male Hormonal Deficiencies/abnormalities
Treatment
CRN04894
Clinical Study ID
Ages 16-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participants ≥18 to 75 years of age at the time of signing theInformed Consent Form (ICF). Participants ≥16 years of age may be included in siteslocated in the United States
Classic 21-hydroxylase deficiency
On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone,prednisone, methylprednisolone)
Compliance with glucocorticoid replacement and mineralocorticoid replacement (ifapplicable) regimen during the Screening Period
Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent). For Cohort 4, amean daily dose of ≥11 mg/m²/day of hydrocortisone or hydrocortisone equivalentswill be used for inclusion
If on estrogen therapy (any route), dose must be stable for at least 3 months priorto Screening
Exclusion
Exclusion Criteria:
Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency
Dexamethasone use within 30 days of Screening for Cohorts 1-3. In Cohort 4,dexamethasone is permitted
History of bilateral adrenalectomy, hypopituitarism, or other condition requiringchronic glucocorticoid therapy
Night shift workers or any other reason for abnormal sleep/wake cycles
Clinically significant unstable medical condition or chronic disease other than CAH
History of major surgery/surgical therapy for any cause within 4 weeks prior toScreening
Diabetes mellitus treated with insulin for less than 6 weeks prior to Screening, orwith change in total daily insulin dose by >15% within 6 weeks prior to Screening
Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%(≥69 mmol/mL), or estimated HbA1c based on fructosamine if HbA1c is notevaluable (eg, due to hemoglobinopathies)
Participants with hypothyroidism who are not receiving adequate hormone replacementtherapy based on thyroid hormone levels measured at the time of Screening
History of unstable angina or acute myocardial infarction within 12 weeks prior toScreening or other clinically significant cardiac disease at the time of Screening
History of cancer excluding cured/treated dermal squamous or basal cell carcinoma orcervical carcinoma in situ
Pregnant or lactating
Known history of illicit drug or alcohol abuse within the last year
Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride,cyproterone acetate, flutamide)
Use of testosterone, androgen-containing supplements, aromatase inhibitors, orgrowth hormone
Study Design
Study Description
Connect with a study center
Crinetics Study Site
Córdoba, Córdoba Province 5000
ArgentinaActive - Recruiting
Crinetics Study Site
Buenos Aires, C1180
ArgentinaActive - Recruiting
Crinetics Study Site
Curitiba, Paraná 80030-110
BrazilActive - Recruiting
Crinetics Study Site
Porto Alegre, Rio Grande Do Sul 90410-000
BrazilActive - Recruiting
Crinetics Study Site
Botucatu, São Paulo 18618-686
BrazilActive - Recruiting
Crinetics Study Site
Ribeirão Preto, São Paulo 14051-140
BrazilActive - Recruiting
Crinetics Study Site
Rio De Janeiro, 20231-092
BrazilActive - Recruiting
Crinetics Study Site
São Paulo, 04024-002
BrazilActive - Recruiting
Crinetics Study Site
Munich, Bavaria 80336
GermanyActive - Recruiting
Crinetics Study Site
Bangalore, Karnataka 560054
IndiaActive - Recruiting
Crinetics Study Site
Vellore, Tamil Nadu 632004
IndiaActive - Recruiting
Crinetics Study Site
Napoli, 80131
ItalyActive - Recruiting
Crinetics Study Site
Roma, 00161
ItalyActive - Recruiting
Crinetics Study Site
Rozzano, 20089
ItalyActive - Recruiting
Crinetics Study Site
Sheffield, South Yorkshire S10 2RX
United KingdomActive - Recruiting
Crinetics Study Site
London, NW1 2PG
United KingdomActive - Recruiting
Crinetics Study Site
Pasadena, California 91105
United StatesActive - Recruiting
Crinetics Study Site
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Crinetics Study Site
Minneapolis, Minnesota 55454
United StatesActive - Recruiting
Crinetics Study Site
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Crinetics Study Site
Morehead City, North Carolina 28557
United StatesActive - Recruiting
Crinetics Study Site
Cleveland, Ohio 44195
United StatesActive - Recruiting
Crinetics Study Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Crinetics Study Site
East Providence, Rhode Island 02915
United StatesActive - Recruiting
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