A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia

Last updated: June 2, 2026
Sponsor: Crinetics Pharmaceuticals Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Congenital Adrenal Hyperplasia

Male Hormonal Deficiencies/abnormalities

Treatment

Atumelnant

Placebo

Clinical Study ID

NCT07144163
CRN04894-12
2024-519579-24-00
  • Ages 18-74
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.

Eligibility Criteria

Inclusion

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 inthe 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.

  1. 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, cortisoneacetate) at the time of informed consent.

  2. If treated with mineralocorticoids (fludrocortisone), the dose should be stable forat least 1 month prior to Screening without orthostatic hypotension, and with serumsodium and potassium in the normal range.

  3. If on estrogen therapy (any route), the dose must be stable for at least 3 monthsprior to Screening.

Exclusion

Exclusion Criteria:

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

  2. History of bilateral adrenalectomy, hypopituitarism, or other condition requiringchronic GC therapy.

  3. Clinically significant medical condition or abnormal laboratory tests, as judged bythe 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 compliancewith medical instructions.

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

  6. Women who are pregnant or lactating or, if of childbearing potential, who areunwilling to use highly effective contraception as described in this study. Maleparticipants who are unwilling to use highly effective contraception as described inthis study.

  7. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant orany of its excipients.

  8. Participants with an increased risk of developing adrenal insufficiency as judged bythe Investigator.

  9. Severe erythrocytosis as judged by the Investigator.

  10. Use of atumelnant prior to screening.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Atumelnant
Phase: 3
Study Start date:
December 11, 2025
Estimated Completion Date:
May 31, 2027

Study Description

This is a Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study in adult participants (male or female age ≥18 to <75 years) with classic CAH due to 21-OHD who have been on a stable regimen of GCs for at least 2 months to evaluate efficacy, safety, PK, and PD of atumelnant administered once per day. Following a 3- to 6-week Screening Period, eligible participants will enter the Treatment Period where they will be randomly assigned in a 2:1 ratio to receive either atumelnant 80 mg once daily (with an option for dose escalation to 120 mg once daily at Week 20) or placebo.

A total of approximately 150 participants may be enrolled in the study.

Connect with a study center

  • Crinetics Study Site

    Buenos Aires, Buenos Aires F.D. C1012AAR
    Argentina

    Active - Recruiting

  • Crinetics Study Site

    CABA, Buenos Aires F.D. C1199ABB
    Argentina

    Active - Recruiting

  • Crinetics Study Site

    Córdoba, Córdoba Province X5000JRD
    Argentina

    Active - Recruiting

  • Crinetics Study Site

    Herston, Queensland 4029
    Australia

    Active - Recruiting

  • Crinetics Study Site

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Crinetics Study Site

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Crinetics Study Site

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Crinetics Study Site

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Crinetics Study Site

    Vienna, 1090
    Austria

    Active - Recruiting

  • Crinetics Study Site

    Curitiba, Paraná 33172
    Brazil

    Active - Recruiting

  • Crinetics Study Site

    Rio de Janeiro, Rio de Janeiro 20551-030
    Brazil

    Active - Recruiting

  • Crinetics Study Site

    Botucatu, São Paulo 18618-686
    Brazil

    Active - Recruiting

  • Crinetics Study Site

    São Paulo, São Paulo 05403-000
    Brazil

    Active - Recruiting

  • Crinetics Study Site

    Angers, 49933
    France

    Active - Recruiting

  • Crinetics Study Site

    Bron, 69500
    France

    Active - Recruiting

  • Crinetics Study Site

    Nantes, 44093 Cedex 1
    France

    Active - Recruiting

  • Crinetics Study Site

    Paris, 75013
    France

    Active - Recruiting

  • Crinetics Study Site

    Pessac, 33604
    France

    Active - Recruiting

  • Crinetics Study Site

    Vandœuvre-lès-Nancy, 54500
    France

    Active - Recruiting

  • Crinetics Study Site

    Munich, Bavaria 80336
    Germany

    Active - Recruiting

  • Crinetics Study Site

    Würzburg, 97080
    Germany

    Active - Recruiting

  • Crinetics Study Site

    Milan, Milano 20149
    Italy

    Active - Recruiting

  • Crinetics Study Site

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Crinetics Study Site

    Padova, Padova 35128
    Italy

    Active - Recruiting

  • Crinetics Study Site

    Palermo, Palermo 90127
    Italy

    Active - Recruiting

  • Crinetics Study Site

    Naples, 80131
    Italy

    Active - Recruiting

  • Crinetics Study Site

    Roma, 00161
    Italy

    Active - Recruiting

  • Crinetics Study Site

    Warsaw, Masovian Voivodeship 00-189
    Poland

    Active - Recruiting

  • Crinetics Study Site

    Lodz, Łódź Voivodeship 93-338
    Poland

    Active - Recruiting

  • Crinetics Study Site

    Gothenburg, 413 46
    Sweden

    Active - Recruiting

  • Crinetics Study Site

    Stockholm, 171 76
    Sweden

    Active - Recruiting

  • Crinetics Study Site

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • Crinetics Study Site

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Crinetics Study Site

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Crinetics Study Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Crinetics Study Site

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Crinetics Study Site

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Crinetics Study Site

    Minneapolis, Minnesota 55417
    United States

    Active - Recruiting

  • Crinetics Study Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Crinetics Study Site

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Crinetics Study Site

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Crinetics Study Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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