A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
NCT ID: NCT07144163
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2025-12-11
2027-05-31
Brief Summary
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Detailed Description
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A total of approximately 150 participants may be enrolled in the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment
Atumelnant tablet, administered orally, once daily for 32 weeks.
Atumelnant
Atumelnant, tablets, once daily by mouth
Placebo
Matching placebo, administered orally, once daily for 32 weeks.
Placebo
Placebo, tablets, once daily by mouth
Interventions
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Atumelnant
Atumelnant, tablets, once daily by mouth
Placebo
Placebo, tablets, once daily by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 and approved by the Medical Monitor.
4. Participants with levels of morning serum A4 as follows:
* A4 \>ULN and treated with \<11 mg/m2/day (physiologic) GC doses
* OR normal A4 (above mid-range to ≤ULN) and treated with ≥15 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 2 months 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
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.
18 Years
74 Years
ALL
No
Sponsors
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Crinetics Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Crinetics Study Site
Herston, Queensland, Australia
Crinetics Study Site
Woolloongabba, Queensland, Australia
Crinetics Study Site
Adelaide, South Australia, Australia
Crinetics Study Site
Parkville, Victoria, Australia
Crinetics Study Site
Nedlands, Western Australia, Australia
Countries
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Central Contacts
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Other Identifiers
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2024-519579-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
CRN04894-12
Identifier Type: -
Identifier Source: org_study_id