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New pill may help adults with rare adrenal disorder cut back on steroids

NCT ID NCT07144163

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 03, 2026 · Updated 5 times

Summary

This study tests a new drug, atumelnant, in 150 adults with classic congenital adrenal hyperplasia (CAH). The goal is to see if it can safely control hormone levels and allow patients to take lower doses of their usual steroid medications. Participants will receive either atumelnant or a placebo, and researchers will monitor hormone levels and side effects over time.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

May 2027

An estimate. End dates often move.

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

18 to 74 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, between ≥18 to \<75 years of age at the time of signing the ICF. 2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment. 3. Have classic CAH due to 21-OHD confirmed by the Investigator. 4. Participants with Visit 2 levels of morning serum A4 as follows: * A4 \>ULN and treated with \<11 mg/m2/day (physiologic) GC doses * OR normal A4 (\>0.5xULN to ≤1xULN) and treated with ≥14 mg/m2/day GC doses * OR A4 \>ULN and treated with ≥11 mg/m2/day GC doses. 5. On a stable (defined as no dose change of \>5 mg/day hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (e.g., hydrocortisone, prednisolone, prednisone, methylprednisolone, meprednisone, dexamethasone, cortisone acetate) at the time of informed consent. 6. If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range. 7. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening. Exclusion Criteria: 1. Diagnosis of any form of CAH other than classic 21-OHD. 2. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy. 3. Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH. 4. Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions. 5. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ. 6. Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study. 7. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients. 8. Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator. 9. Severe erythrocytosis as judged by the Investigator. 10. Use of atumelnant prior to screening.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    68 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Crinetics Study Site

    RECRUITING

    Los Angeles, California, 90027, United States

  • Crinetics Study Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Crinetics Study Site

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    Gainesville, Florida, 32610, United States

  • Crinetics Study Site

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    Atlanta, Georgia, 30322, United States

  • Crinetics Study Site

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    Chicago, Illinois, 60611, United States

  • Crinetics Study Site

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    Baltimore, Maryland, 21287, United States

  • Crinetics Study Site

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    Ann Arbor, Michigan, 48109, United States

  • Crinetics Study Site

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    Minneapolis, Minnesota, 55417, United States

  • Crinetics Study Site

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    Rochester, Minnesota, 55905, United States

  • Crinetics Study Site

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    Philadelphia, Pennsylvania, 19104, United States

  • Crinetics Study Site

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    Pittsburgh, Pennsylvania, 15213, United States

  • Crinetics Study Site

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    Dallas, Texas, 75390, United States

  • Crinetics Study Site

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    Milwaukee, Wisconsin, 53226, United States

  • Crinetics Study Site

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    Buenos Aires, Buenos Aires F.D., 1405, Argentina

  • Crinetics Study Site

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    Buenos Aires, Buenos Aires F.D., C1012AAR, Argentina

  • Crinetics Study Site

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    CABA, Buenos Aires F.D., 1119, Argentina

  • Crinetics Study Site

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    CABA, Buenos Aires F.D., C1199ABB, Argentina

  • Crinetics Study Site

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    Córdoba, Córdoba Province, X5000JRD, Argentina

  • Crinetics Study Site

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    Herston, Queensland, 4029, Australia

  • Crinetics Study Site

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    Woolloongabba, Queensland, 4102, Australia

  • Crinetics Study Site

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    Adelaide, South Australia, 5000, Australia

  • Crinetics Study Site

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    Parkville, Victoria, 3050, Australia

  • Crinetics Study Site

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    Nedlands, Western Australia, 6009, Australia

  • Crinetics Study Site

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    Graz, Styria, 8036, Austria

  • Crinetics Study Site

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    Vienna, 1090, Austria

  • Crinetics Study Site

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    Fortaleza, Ceará, 60430-275, Brazil

  • Crinetics Study Site

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    Curitiba, Paraná, 80030-110, Brazil

  • Crinetics Study Site

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

  • Crinetics Study Site

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    Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

  • Crinetics Study Site

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

  • Crinetics Study Site

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    Botucatu, São Paulo, 18618-686, Brazil

  • Crinetics Study Site

    RECRUITING

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Crinetics Study Site

    RECRUITING

    São Paulo, São Paulo, 04024-002, Brazil

  • Crinetics Study Site

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    São Paulo, São Paulo, 05403-000, Brazil

  • Crinetics Study Site

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    Angers, 49933, France

  • Crinetics Study Site

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    Bron, 69500, France

  • Crinetics Study Site

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    Nantes, 44093 Cedex 1, France

  • Crinetics Study Site

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    Paris, 75013, France

  • Crinetics Study Site

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    Pessac, 33604, France

  • Crinetics Study Site

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • Crinetics Study Site

    RECRUITING

    Munich, Bavaria, 80336, Germany

  • Crinetics Study Site

    RECRUITING

    Würzburg, 97080, Germany

  • Crinetics Study Site

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    Genova, Genova, 16132, Italy

  • Crinetics Study Site

    RECRUITING

    Milan, Milano, 20132, Italy

  • Crinetics Study Site

    RECRUITING

    Milan, Milano, 20149, Italy

  • Crinetics Study Site

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Crinetics Study Site

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    Modena, Modena, 41126, Italy

  • Crinetics Study Site

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    Padova, Padova, 35128, Italy

  • Crinetics Study Site

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    Palermo, Palermo, 90127, Italy

  • Crinetics Study Site

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    Naples, 80131, Italy

  • Crinetics Study Site

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    Roma, 00161, Italy

  • Crinetics Study Site

    RECRUITING

    Hiroshima, Hiroshima, 734-8551, Japan

  • Crinetics Study Site

    RECRUITING

    Asahikawa, Hokkaido, 078-8510, Japan

  • Crinetics Study Site

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Crinetics Study Site

    RECRUITING

    Fuchu-shi, Tokyo, 183-8561, Japan

  • Crinetics Study Site

    RECRUITING

    Shinjuku-ku, Tokyo, 162-8655, Japan

  • Crinetics Study Site

    RECRUITING

    Shinjuku-ku, Tokyo, 162-8666, Japan

  • Crinetics Study Site

    RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • Crinetics Study Site

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-354, Poland

  • Crinetics Study Site

    RECRUITING

    Warsaw, Masovian Voivodeship, 00-189, Poland

  • Crinetics Study Site

    RECRUITING

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Crinetics Study Site

    RECRUITING

    Riyadh, Riyadh Region, 11211, Saudi Arabia

  • Crinetics Study Site

    RECRUITING

    Gothenburg, 413 46, Sweden

  • Crinetics Study Site

    RECRUITING

    Stockholm, 171 76, Sweden

  • Crinetics Study Site

    RECRUITING

    Cardiff, Wales, CF14 4xW, United Kingdom

  • Crinetics Study Site

    RECRUITING

    London, NW1 2PG, United Kingdom

  • Crinetics Study Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Crinetics Study Site

    RECRUITING

    Sheffield, S10 2JF, United Kingdom

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