NCT07144163 A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
| NCT ID | NCT07144163 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Crinetics Pharmaceuticals Inc. |
| Condition | Congenital Adrenal Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2025-12-11 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07144163 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Congenital Adrenal Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07144163 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT07144163 currently recruiting?
Yes, NCT07144163 is actively recruiting participants. Contact the research team at clinicaltrials@crinetics.com for enrollment information.
Where is the NCT07144163 trial being conducted?
This trial is being conducted at Los Angeles, United States, Aurora, United States, Gainesville, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT07144163 clinical trial?
NCT07144163 is sponsored by Crinetics Pharmaceuticals Inc.. The trial plans to enroll 150 participants.