Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

Last updated: September 19, 2025
Sponsor: Crinetics Pharmaceuticals Inc.
Overall Status: Completed

Phase

2

Condition

Congenital Adrenal Hyperplasia

Male Hormonal Deficiencies/abnormalities

Treatment

atumelnant (CRN04894)

CRN04894

Clinical Study ID

NCT05907291
CRN04894-03
2023-503488-40-00
  • Ages 16-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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

  2. Classic 21-hydroxylase deficiency

  3. On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone,prednisone, methylprednisolone)

  4. Compliance with glucocorticoid replacement and mineralocorticoid replacement (ifapplicable) regimen during the Screening Period

  5. 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

  6. If on estrogen therapy (any route), dose must be stable for at least 3 months priorto Screening

Exclusion

Exclusion Criteria:

  1. Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency

  2. Dexamethasone use within 30 days of Screening for Cohorts 1-3. In Cohort 4,dexamethasone is permitted

  3. History of bilateral adrenalectomy, hypopituitarism, or other condition requiringchronic glucocorticoid therapy

  4. Night shift workers or any other reason for abnormal sleep/wake cycles

  5. Clinically significant unstable medical condition or chronic disease other than CAH

  6. History of major surgery/surgical therapy for any cause within 4 weeks prior toScreening

  7. 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

  8. 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)

  9. Participants with hypothyroidism who are not receiving adequate hormone replacementtherapy based on thyroid hormone levels measured at the time of Screening

  10. History of unstable angina or acute myocardial infarction within 12 weeks prior toScreening or other clinically significant cardiac disease at the time of Screening

  11. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma orcervical carcinoma in situ

  12. Pregnant or lactating

  13. Known history of illicit drug or alcohol abuse within the last year

  14. Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride,cyproterone acetate, flutamide)

  15. Use of testosterone, androgen-containing supplements, aromatase inhibitors, orgrowth hormone

Study Design

Total Participants: 38
Treatment Group(s): 2
Primary Treatment: atumelnant (CRN04894)
Phase: 2
Study Start date:
July 03, 2023
Estimated Completion Date:
August 22, 2025

Study Description

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.

Connect with a study center

  • Crinetics Study Site

    Córdoba, Córdoba Province 5000
    Argentina

    Site Not Available

  • Crinetics Study Site

    Córdoba 3860259, Córdoba Province 3860255 5000
    Argentina

    Site Not Available

  • Crinetics Study Site

    Buenos Aires, C1180
    Argentina

    Site Not Available

  • Crinetics Study Site

    Buenos Aires 3435910, C1180
    Argentina

    Site Not Available

  • Crinetics Study Site

    Curitiba, Paraná 80030-110
    Brazil

    Site Not Available

  • Crinetics Study Site

    Curitiba 3464975, Paraná 3455077 80030-110
    Brazil

    Site Not Available

  • Crinetics Study Site

    Porto Alegre, Rio Grande Do Sul 90410-000
    Brazil

    Site Not Available

  • Crinetics Study Site

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90410-000
    Brazil

    Site Not Available

  • Crinetics Study Site

    Rio de Janeiro 3451190, Rio de Janeiro 3451189 20231-092
    Brazil

    Site Not Available

  • Crinetics Study Site

    Botucatu, São Paulo 18618-686
    Brazil

    Site Not Available

  • Crinetics Study Site

    Ribeirão Preto, São Paulo 14051-140
    Brazil

    Site Not Available

  • Crinetics Study Site

    Botucatu 3469136, São Paulo 3448433 18618-686
    Brazil

    Site Not Available

  • Crinetics Study Site

    Ribeirão Preto 3451328, São Paulo 3448433 14051-140
    Brazil

    Site Not Available

  • Crinetics Study Site

    Rio De Janeiro, 20231-092
    Brazil

    Site Not Available

  • Crinetics Study Site

    São Paulo, 04024-002
    Brazil

    Site Not Available

  • Crinetics Study Site

    São Paulo 3448439, 05403-000
    Brazil

    Site Not Available

  • Crinetics Study Site

    Munich, Bavaria 80336
    Germany

    Site Not Available

  • Crinetics Study Site

    Munich 2867714, Bavaria 2951839 80336
    Germany

    Site Not Available

  • Crinetics Study Site

    Bangalore, Karnataka 560054
    India

    Site Not Available

  • Crinetics Study Site

    Bangalore 1277333, Karnataka 1267701 560054
    India

    Site Not Available

  • Crinetics Study Site

    Vellore, Tamil Nadu 632004
    India

    Site Not Available

  • Crinetics Study Site

    Vellore 1253286, Tamil Nadu 1255053 632004
    India

    Site Not Available

  • Crinetics Study Site

    Napoli, 80131
    Italy

    Site Not Available

  • Crinetics Study Site

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • Crinetics Study Site

    Roma, 00161
    Italy

    Site Not Available

  • Crinetics Study Site

    Roma 8957247, 00161
    Italy

    Site Not Available

  • Crinetics Study Site

    Rozzano, 20089
    Italy

    Site Not Available

  • Crinetics Study Site

    Rozzano 3168837, 20089
    Italy

    Site Not Available

  • Crinetics Study Site

    Sheffield, South Yorkshire S10 2RX
    United Kingdom

    Site Not Available

  • Crinetics Study Site

    Sheffield 2638077, South Yorkshire S10 2RX
    United Kingdom

    Site Not Available

  • Crinetics Study Site

    Coventry, West Midlands CV22DX
    United Kingdom

    Site Not Available

  • Crinetics Study Site

    Coventry 2652221, West Midlands CV22DX
    United Kingdom

    Site Not Available

  • Crinetics Study Site

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • Crinetics Study Site

    London 2643743, NW1 2PG
    United Kingdom

    Site Not Available

  • Crinetics Study Site

    Pasadena, California 91105
    United States

    Site Not Available

  • Crinetics Study Site

    Pasadena 5381396, California 5332921 91105
    United States

    Site Not Available

  • Crinetics Study Site

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Crinetics Study Site

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Crinetics Study Site

    Minneapolis, Minnesota 55454
    United States

    Site Not Available

  • Crinetics Study Site

    Minneapolis 5037649, Minnesota 5037779 55454
    United States

    Site Not Available

  • Crinetics Study Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Crinetics Study Site

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Crinetics Study Site

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Crinetics Study Site

    Morehead City 4480153, North Carolina 4482348 28557
    United States

    Site Not Available

  • Crinetics Study Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Crinetics Study Site

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Crinetics Study Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Crinetics Study Site

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Crinetics Study Site

    East Providence, Rhode Island 02915
    United States

    Site Not Available

  • Crinetics Study Site

    East Providence 5221931, Rhode Island 5224323 02915
    United States

    Site Not Available

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