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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of Atumelnant in Adults With Classic Congenital Adrenal Hyperplasia
Led by Crinetics Pharmaceuticals Inc. · Updated on 2026-06-04
150
Participants Needed
45
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of atumelnant in adults with classic Congenital Adrenal Hyperplasia (CAH) due to 21-hydroxylase deficiency. This Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study aims to assess the drug's efficacy, safety, pharmacokinetics, and pharmacodynamics in participants aged 18 to under 75 years who have been on stable glucocorticoid therapy for at least two months. Participants will be randomly assigned in a 2:1 ratio to receive either atumelnant 80 mg once daily or a matching placebo for 32 weeks. There is an option to increase the atumelnant dose to 120 mg daily at Week 20. Before treatment begins, a screening period of 3 to 6 weeks will determine eligibility. Approximately 150 participants may take part in this study. During the study, participants will be monitored for hormone levels related to CAH and glucocorticoid dosing, with primary outcomes measured at Week 32. Assessments include morning serum androstenedione levels and other hormone markers. Safety and adherence to study procedures will also be closely observed. The study period extends up to 32 weeks of treatment following screening, with detailed evaluations throughout.
CONDITIONS
Brief Title
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 to under 75 years at consent
- Willing and able to follow study procedures and treatment
- Diagnosed with classic CAH due to 21-hydroxylase deficiency confirmed by investigator
- Specific morning serum androstenedione (A4) levels and glucocorticoid dosing as defined
- On stable glucocorticoid replacement therapy for at least 2 months before consent
- If on mineralocorticoids, stable dose for at least 1 month without orthostatic hypotension and normal sodium and potassium levels
- If on estrogen therapy, stable dose for at least 3 months before screening
You will not qualify if you...
- Diagnosis of any CAH form other than classic 21-hydroxylase deficiency
- History of bilateral adrenalectomy, hypopituitarism, or other chronic glucocorticoid therapy
- Significant medical conditions or abnormal labs unrelated to CAH as judged by investigator
- Mental condition impairing understanding or compliance with study
- History of cancer except treated non-melanoma skin or cervical carcinoma in situ
- Pregnant or lactating women or those unwilling to use effective contraception; similarly for men
- Known hypersensitivity to atumelnant or its ingredients
- Increased risk of adrenal insufficiency as judged by investigator
- Severe erythrocytosis as judged by investigator
- Prior use of atumelnant before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 3 to 6 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 32 weeks
Participants receive atumelnant or placebo tablets once daily to evaluate the safety and efficacy of atumelnant in adults with classic congenital adrenal hyperplasia.
Regular visits during treatment as per study protocol
Trial Site Locations
Total: 45 locations
1
Crinetics Study Site
Los Angeles, California, United States, 90027
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2
Crinetics Study Site
Atlanta, Georgia, United States, 30322
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3
Crinetics Study Site
Chicago, Illinois, United States, 60611
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4
Crinetics Study Site
Ann Arbor, Michigan, United States, 48109
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5
Crinetics Study Site
Minneapolis, Minnesota, United States, 55417
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6
Crinetics Study Site
Rochester, Minnesota, United States, 55905
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7
Crinetics Study Site
Pittsburgh, Pennsylvania, United States, 15213
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8
Crinetics Study Site
Dallas, Texas, United States, 75390
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9
Crinetics Study Site
Milwaukee, Wisconsin, United States, 53226
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10
Crinetics Study Site
Buenos Aires, Buenos Aires F.D., Argentina, 1405
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11
Crinetics Study Site
Buenos Aires, Buenos Aires F.D., Argentina, C1012AAR
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12
Crinetics Study Site
CABA, Buenos Aires F.D., Argentina, C1199ABB
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13
Crinetics Study Site
Córdoba, Córdoba Province, Argentina, X5000JRD
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14
Crinetics Study Site
Herston, Queensland, Australia, 4029
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15
Crinetics Study Site
Woolloongabba, Queensland, Australia, 4102
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16
Crinetics Study Site
Adelaide, South Australia, Australia, 5000
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17
Crinetics Study Site
Parkville, Victoria, Australia, 3050
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18
Crinetics Study Site
Nedlands, Western Australia, Australia, 6009
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19
Crinetics Study Site
Vienna, Austria, 1090
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20
Crinetics Study Site
Curitiba, Paraná, Brazil, 33172
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21
Crinetics Study Site
Rio de Janeiro, Rio de Janeiro, Brazil, 20231-092
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22
Crinetics Study Site
Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
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23
Crinetics Study Site
Botucatu, São Paulo, Brazil, 18618-686
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24
Crinetics Study Site
São Paulo, São Paulo, Brazil, 04024-002
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25
Crinetics Study Site
São Paulo, São Paulo, Brazil, 05403-000
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26
Crinetics Study Site
Angers, France, 49933
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27
Crinetics Study Site
Bron, France, 69500
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28
Crinetics Study Site
Nantes, France, 44093 Cedex 1
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29
Crinetics Study Site
Paris, France, 75013
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30
Crinetics Study Site
Pessac, France, 33604
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31
Crinetics Study Site
Vandœuvre-lès-Nancy, France, 54500
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32
Crinetics Study Site
Munich, Bavaria, Germany, 80336
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33
Crinetics Study Site
Würzburg, Germany, 97080
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34
Crinetics Study Site
Milan, Milano, Italy, 20149
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35
Crinetics Study Site
Rozzano, Milano, Italy, 20089
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36
Crinetics Study Site
Padova, Padova, Italy, 35128
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37
Crinetics Study Site
Palermo, Palermo, Italy, 90127
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38
Crinetics Study Site
Naples, Italy, 80131
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39
Crinetics Study Site
Roma, Italy, 00161
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40
Crinetics Study Site
Warsaw, Masovian Voivodeship, Poland, 00-189
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41
Crinetics Study Site
Lodz, Łódź Voivodeship, Poland, 93-338
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42
Crinetics Study Site
Gothenburg, Sweden, 413 46
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43
Crinetics Study Site
Stockholm, Sweden, 171 76
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44
Crinetics Study Site
London, United Kingdom, NW1 2PG
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45
Crinetics Study Site
Manchester, United Kingdom, M20 4BX
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Research Team
C
Crinetics Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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