A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia

NCT07144163 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CRN04894-122024-519579-24-00
• Study Type: interventional
• Target: 150
• Locations: 8 countries
• Sites: 26

Brief 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.

Conditions

Classic Congenital Adrenal Hyperplasia; Congenital Adrenal Hyperplasia

Keywords

Congenital Adrenal Hyperplasia; CAH; CRN04894; Atumelnant; Adult; Calm-CAH

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement.

  Week 32

Secondary Outcomes (4)

• Percent change from baseline of morning pre-GC A4

  Week 2

• Percent change from baseline of morning pre-GC 17-OHP

  Week 32

• Proportion of participants with morning pre-GC A4 ≤ ULN who are on physiologic GC replacement

  Week 32

• Percent change from baseline in GC daily dose when morning post-GC A4 ≤ ULN

  Week 32

Study Arms (2)

Treatment

EXPERIMENTAL

Atumelnant tablet, administered orally, once daily for 32 weeks.

Drug: Atumelnant

Placebo

PLACEBO COMPARATOR

Matching placebo, administered orally, once daily for 32 weeks.

Drug: Placebo

Interventions

Atumelnant DRUG

Atumelnant, tablets, once daily by mouth

Also known as: CRN04894

Treatment

Placebo DRUG

Placebo, tablets, once daily by mouth

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, between ≥18 to \<75 years of age at the time of signing the ICF.
• Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
• Have classic CAH due to 21-OHD confirmed by the Investigator.
• 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.
• 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.
• 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.
• If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.

You may not qualify if:

• Diagnosis of any form of CAH other than classic 21-OHD.
• History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.
• Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.
• 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.
• History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
• 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.
• Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.
• Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.
• Severe erythrocytosis as judged by the Investigator.
• Use of atumelnant prior to screening.

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (26)

Crinetics Study Site

Chicago, Illinois, 60611, United States

RECRUITING

Crinetics Study Site

Ann Arbor, Michigan, 48109, United States

RECRUITING

Crinetics Study Site

Rochester, Minnesota, 55905, United States

RECRUITING

Crinetics Study Site

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

RECRUITING

Crinetics Study Site

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

RECRUITING

Crinetics Study Site

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

RECRUITING

Crinetics Study Site

Córdoba, Córdoba Province, X5000JRD, Argentina

RECRUITING

Crinetics Study Site

Herston, Queensland, 4029, Australia

RECRUITING

Crinetics Study Site

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Crinetics Study Site

Adelaide, South Australia, 5000, Australia

RECRUITING

Crinetics Study Site

Parkville, Victoria, 3050, Australia

RECRUITING

Crinetics Study Site

Nedlands, Western Australia, 6009, Australia

RECRUITING

Crinetics Study Site

Curitiba, Paraná, 33172, Brazil

RECRUITING

Crinetics Study Site

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

RECRUITING

Crinetics Study Site

Botucatu, São Paulo, 18618-686, Brazil

RECRUITING

Crinetics Study Site

São Paulo, São Paulo, 04024-002, Brazil

RECRUITING

Crinetics Study Site

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Crinetics Study Site

Angers, 49933, France

RECRUITING

Crinetics Study Site

Bron, 69500, France

RECRUITING

Crinetics Study Site

Nantes, 44093 Cedex 1, France

RECRUITING

Crinetics Study Site

Pessac, 33604, France

RECRUITING

Crinetics Study Site

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Crinetics Study Site

Munich, Bavaria, 80336, Germany

RECRUITING

Crinetics Study Site

Würzburg, 97080, Germany

RECRUITING

Crinetics Study Site

Milan, Milano, 20149, Italy

RECRUITING

Crinetics Study Site

Warsaw, Masovian Voivodeship, 00-189, Poland

RECRUITING

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Crinetics Clinical Trials

CONTACT

833-827-9741; clinicaltrials@crinetics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); DE (2); PL (1); US (3); AR (4); BR (5); FR (5); AU (5)