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NCT07144163PHASE3Recruiting

A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia

Crinetics Pharmaceuticals Inc.

Start Date

12/11/2025

Completion Date

5/1/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 74 years

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.

Interventions

DRUG

Atumelnant

DRUG

Placebo

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Conditions

Congenital Adrenal HyperplasiaClassic Congenital Adrenal Hyperplasia

Locations

Crinetics Study Site

Los Angeles, California 90027

United States

Crinetics Study Site

Atlanta, Georgia 30322

United States

Crinetics Study Site

Chicago, Illinois 60611

United States

Crinetics Study Site

Baltimore, Maryland 21287

United States

Crinetics Study Site

Ann Arbor, Michigan 48109

United States

Crinetics Study Site

Minneapolis, Minnesota 55417

United States

Crinetics Study Site

Rochester, Minnesota 55905

United States

Crinetics Study Site

Pittsburgh, Pennsylvania 15213

United States

Crinetics Study Site

Dallas, Texas 75390

United States

Crinetics Study Site

Milwaukee, Wisconsin 53226

United States

Crinetics Study Site

Buenos Aires, Buenos Aires F.D. 1405

Argentina

Crinetics Study Site

Buenos Aires, Buenos Aires F.D. C1012AAR

Argentina

Crinetics Study Site

CABA, Buenos Aires F.D. 1119

Argentina

Crinetics Study Site

CABA, Buenos Aires F.D. C1199ABB

Argentina

Crinetics Study Site

Córdoba, Córdoba Province X5000JRD

Argentina

Crinetics Study Site

Herston, Queensland 4029

Australia

Crinetics Study Site

Woolloongabba, Queensland 4102

Australia

Crinetics Study Site

Adelaide, South Australia 5000

Australia

Crinetics Study Site

Parkville, Victoria 3050

Australia

Crinetics Study Site

Nedlands, Western Australia 6009

Australia

Crinetics Study Site

Vienna, 1090

Austria

Crinetics Study Site

Fortaleza, Ceará 60430-275

Brazil

Crinetics Study Site

Curitiba, Paraná 80030-110

Brazil

Crinetics Study Site

Rio de Janeiro, Rio de Janeiro 20231-092

Brazil

Crinetics Study Site

Rio de Janeiro, Rio de Janeiro 20551-030

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

São Paulo, São Paulo 04024-002

Brazil

Crinetics Study Site

São Paulo, São Paulo 05403-000

Brazil

Crinetics Study Site

Angers, 49933

France

Crinetics Study Site

Bron, 69500

France

Crinetics Study Site

Nantes, 44093 Cedex 1

France

Crinetics Study Site

Paris, 75013

France

Crinetics Study Site

Pessac, 33604

France

Crinetics Study Site

Vandœuvre-lès-Nancy, 54500

France

Crinetics Study Site

Munich, Bavaria 80336

Germany

Crinetics Study Site

Würzburg, 97080

Germany

Crinetics Study Site

Milan, Milano 20132

Italy

Crinetics Study Site

Milan, Milano 20149

Italy

Crinetics Study Site

Rozzano, Milano 20089

Italy

Crinetics Study Site

Modena, Modena 41126

Italy

Crinetics Study Site

Padova, Padova 35128

Italy

Crinetics Study Site

Palermo, Palermo 90127

Italy

Crinetics Study Site

Naples, 80131

Italy

Crinetics Study Site

Roma, 00161

Italy

Crinetics Study Site

Leiden, South Holland 2333 ZA

Netherlands

Crinetics Study Site

Poznan, Greater Poland Voivodeship 60-354

Poland

Crinetics Study Site

Warsaw, Masovian Voivodeship 00-189

Poland

Crinetics Study Site

Lodz, Łódź Voivodeship 93-338

Poland

Crinetics Study Site

Riyadh, Riyadh Region 11211

Saudi Arabia

Crinetics Study Site

Gothenburg, 413 46

Sweden

Crinetics Study Site

Stockholm, 171 76

Sweden

Crinetics Study Site

Cardiff, Wales CF14 4xW

United Kingdom

Crinetics Study Site

London, NW1 2PG

United Kingdom

Crinetics Study Site

Manchester, M20 4BX

United Kingdom