Atumelnant: Atumelnant, tablets, once daily by mouth
Placebo: Placebo, tablets, once daily by mouth
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
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement. — Week 32
Trial sites (68)
Facility
City
Region
Status
Crinetics Study Site
Los Angeles
California
Recruiting
Crinetics Study Site
Aurora
Colorado
Recruiting
Crinetics Study Site
Gainesville
Florida
Recruiting
Crinetics Study Site
Atlanta
Georgia
Recruiting
Crinetics Study Site
Chicago
Illinois
Recruiting
Crinetics Study Site
Baltimore
Maryland
Recruiting
Crinetics Study Site
Ann Arbor
Michigan
Recruiting
Crinetics Study Site
Minneapolis
Minnesota
Recruiting
Crinetics Study Site
Rochester
Minnesota
Recruiting
Crinetics Study Site
Philadelphia
Pennsylvania
Recruiting
Crinetics Study Site
Pittsburgh
Pennsylvania
Recruiting
Crinetics Study Site
Dallas
Texas
Recruiting
Crinetics Study Site
Milwaukee
Wisconsin
Recruiting
Crinetics Study Site
Buenos Aires
Buenos Aires F.D.
Recruiting
Crinetics Study Site
Buenos Aires
Buenos Aires F.D.
Recruiting
Crinetics Study Site
CABA
Buenos Aires F.D.
Recruiting
Crinetics Study Site
CABA
Buenos Aires F.D.
Recruiting
Crinetics Study Site
Córdoba
Córdoba Province
Recruiting
Crinetics Study Site
Herston
Queensland
Recruiting
Crinetics Study Site
Woolloongabba
Queensland
Recruiting
Crinetics Study Site
Adelaide
South Australia
Recruiting
Crinetics Study Site
Parkville
Victoria
Recruiting
Crinetics Study Site
Nedlands
Western Australia
Recruiting
Crinetics Study Site
Graz
Styria
Recruiting
Crinetics Study Site
Vienna
Austria
Recruiting
Crinetics Study Site
Fortaleza
Ceará
Recruiting
Crinetics Study Site
Curitiba
Paraná
Recruiting
Crinetics Study Site
Rio de Janeiro
Rio de Janeiro
Recruiting
Crinetics Study Site
Rio de Janeiro
Rio de Janeiro
Recruiting
Crinetics Study Site
Porto Alegre
Rio Grande do Sul
Recruiting
Crinetics Study Site
Botucatu
São Paulo
Recruiting
Crinetics Study Site
Ribeirão Preto
São Paulo
Recruiting
Crinetics Study Site
São Paulo
São Paulo
Recruiting
Crinetics Study Site
São Paulo
São Paulo
Recruiting
Crinetics Study Site
Angers
France
Recruiting
Crinetics Study Site
Bron
France
Recruiting
Crinetics Study Site
Nantes
France
Recruiting
Crinetics Study Site
Paris
France
Recruiting
Crinetics Study Site
Pessac
France
Recruiting
Crinetics Study Site
Vandœuvre-lès-Nancy
France
Recruiting
+ 28 more sites — see the full list on the official registry below.
More Crinetics Pharmaceuticals Inc. trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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