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

September 19, 2025 updated by: Crinetics Pharmaceuticals Inc.

A 12-week, Phase 2 Open-label, Sequential Dose Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 Treatment in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1180
        • Crinetics Study Site
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5000
        • Crinetics Study Site
  • Brazil
      • São Paulo, Brazil, 05403-000
        • Crinetics Study Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Crinetics Study Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90410-000
        • Crinetics Study Site
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20231-092
        • Crinetics Study Site
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
        • Crinetics Study Site
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • Crinetics Study Site
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Crinetics Study Site
      • São Paulo, São Paulo, Brazil, 04024-002
        • Crinetics Study Site
  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80336
        • Crinetics Study Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Crinetics Study Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Crinetics Study Site
  • Italy
      • Napoli, Italy, 80131
        • Crinetics Study Site
      • Roma, Italy, 00161
        • Crinetics Study Site
      • Rozzano, Italy, 20089
        • Crinetics Study Site
  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • Crinetics Study Site
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2RX
        • Crinetics Study Site
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV22DX
        • Crinetics Study Site
  • United States
    • California
      • Pasadena, California, United States, 91105
        • Crinetics Study Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Crinetics Study Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Crinetics Study Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Crinetics Study Site
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Crinetics Study Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Crinetics Study Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Crinetics Study Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Crinetics Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female participants ≥18 to 75 years of age at the time of signing the Informed Consent Form (ICF). Participants ≥16 years of age may be included in sites located 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 (if applicable) regimen during the Screening Period
  5. Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent). For Cohort 4, a mean daily dose of ≥11 mg/m²/day of hydrocortisone or hydrocortisone equivalents will be used for inclusion
  6. If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening

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 requiring chronic 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 to Screening
  7. Diabetes mellitus treated with insulin for less than 6 weeks prior to Screening, or with 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 not evaluable (eg, due to hemoglobinopathies)
  9. Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening
  10. History of unstable angina or acute myocardial infarction within 12 weeks prior to Screening or other clinically significant cardiac disease at the time of Screening
  11. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical 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, or growth hormone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential Dose
Sequential, open-label, 12-week fixed-dose cohorts.
Drug: atumelnant (CRN04894)
Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in morning (before 11:00) serum androstenedione (A4)
Time Frame: Week 12
Week 12
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in morning (before 11:00) serum 17-hydroxyprogesterone (17-OHP)
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Crinetics Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Actual)

August 22, 2025

Study Completion (Actual)

August 22, 2025

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRN04894-03
  • 2023-503488-40-00 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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