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New pill could tame rare hormone disorder

NCT ID NCT05907291

Disease control Sponsor: Crinetics Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tested a new oral drug called atumelnant in 38 adults with classic congenital adrenal hyperplasia, a genetic condition causing hormone imbalances. The drug works by blocking a hormone receptor to lower excess adrenal hormones. Researchers measured safety, side effects, and changes in hormone levels over 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atumelnant (CRN04894), an oral drug that blocks a hormone receptor to reduce excess adrenal hormones
What this could lead to
If successful, this could lead to a new oral treatment option for congenital adrenal hyperplasia, potentially reducing the need for high-dose steroids.
What could go wrong
This is an early Phase 2 trial with only 38 participants, so results may not apply to everyone. The drug may cause side effects or fail to improve outcomes significantly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

38 people

The number who actually took part.

Started

Jul 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

classic congenital adrenal hyperplasia classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency congenital adrenal hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Classic congenital adrenal hyperplasia Congenital adrenal hyperplasia

Contacts and locations

Locations

  • Crinetics Study Site

    Pasadena, California, 91105, United States

  • Crinetics Study Site

    Ann Arbor, Michigan, 48109, United States

  • Crinetics Study Site

    Minneapolis, Minnesota, 55454, United States

  • Crinetics Study Site

    St Louis, Missouri, 63110, United States

  • Crinetics Study Site

    Morehead City, North Carolina, 28557, United States

  • Crinetics Study Site

    Cleveland, Ohio, 44195, United States

  • Crinetics Study Site

    Philadelphia, Pennsylvania, 19104, United States

  • Crinetics Study Site

    East Providence, Rhode Island, 02915, United States

  • Crinetics Study Site

    Córdoba, Córdoba Province, 5000, Argentina

  • Crinetics Study Site

    Buenos Aires, C1180, Argentina

  • Crinetics Study Site

    Curitiba, Paraná, 80030-110, Brazil

  • Crinetics Study Site

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

  • Crinetics Study Site

    Botucatu, São Paulo, 18618-686, Brazil

  • Crinetics Study Site

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Crinetics Study Site

    Rio de Janeiro, 20231-092, Brazil

  • Crinetics Study Site

    Rio de Janeiro, 20551-030, Brazil

  • Crinetics Study Site

    São Paulo, 04024-002, Brazil

  • Crinetics Study Site

    São Paulo, 05403-000, Brazil

  • Crinetics Study Site

    Munich, Bavaria, 80336, Germany

  • Crinetics Study Site

    Bangalore, Karnataka, 560054, India

  • Crinetics Study Site

    Vellore, Tamil Nadu, 632004, India

  • Crinetics Study Site

    Naples, 80131, Italy

  • Crinetics Study Site

    Roma, 00161, Italy

  • Crinetics Study Site

    Rozzano, 20089, Italy

  • Crinetics Study Site

    Sheffield, South Yorkshire, S10 2RX, United Kingdom

  • Crinetics Study Site

    Coventry, West Midlands, CV22DX, United Kingdom

  • Crinetics Study Site

    London, NW1 2PG, United Kingdom

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