A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
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
Interventions
Atumelnant
Placebo
Conditions
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
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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
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Riyadh, Riyadh Region 11211
Saudi Arabia
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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