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Atumelnant for adults with classic congenital adrenal hyperplasia

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants With Classic Congenital Adrenal Hyperplasia (Calm-CAH)

Phase 3 Interventional Crinetics Pharmaceuticals Inc. · NCT07144163

This will test whether taking once-daily atumelnant helps adults with classic 21‑hydroxylase deficiency CAH who are already on stable glucocorticoid therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years to 74 Years
SexAll
SponsorCrinetics Pharmaceuticals Inc. Industry-sponsored
Drugs / interventionsprednisone
Locations26 sites (Chicago, Illinois and 25 other locations)
Trial IDNCT07144163 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, double-blind, placebo-controlled trial enrolling approximately 150 adults (age ≥18 to <75) with confirmed classic CAH due to 21‑hydroxylase deficiency who have been on a stable glucocorticoid regimen. After a 3–6 week screening period, participants are randomized 2:1 to atumelnant 80 mg once daily (with an option to escalate to 120 mg at Week 20) or matching placebo. The study will collect efficacy, safety, pharmacokinetic, and pharmacodynamic data while participants continue background glucocorticoid replacement. Multiple clinic visits at study sites will monitor hormone levels, symptoms, and adverse events over the treatment period.

Who should consider this trial

Good fit: Adults aged 18–74 with confirmed classic CAH due to 21‑OHD who are on a stable glucocorticoid replacement regimen and meet the trial's morning androstenedione (A4) and dosing criteria are ideal candidates.

Not a fit: Patients who are children, have nonclassic CAH, are not on stable glucocorticoid doses, are pregnant, or have other medical conditions that preclude safe participation are unlikely to benefit from joining this study.

Why it matters

Potential benefit: If successful, atumelnant could improve hormone control and symptoms of androgen excess and potentially allow safer reductions in glucocorticoid dose.

How similar studies have performed: Early-phase clinical data with atumelnant supported progression to Phase 3, but the approach remains relatively novel and large-scale published outcomes are limited.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Chicago, Illinois and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Congenital Adrenal HyperplasiaClassic Congenital Adrenal HyperplasiaCAHCRN04894AtumelnantAdultCalm-CAH
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.