Atumelnant for adults with classic congenital adrenal hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Crinetics Study Site
  Los Angeles, California, United States Recruiting
• Crinetics Study Site
  Aurora, Colorado, United States Recruiting
• Crinetics Study Site
  Gainesville, Florida, United States Recruiting
• Crinetics Study Site
  Atlanta, Georgia, United States Recruiting
• Crinetics Study Site
  Chicago, Illinois, United States Recruiting
• Crinetics Study Site
  Baltimore, Maryland, United States Recruiting

+32 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Crinetics Clinical Trials
• Email: clinicaltrials@crinetics.com
• Phone: 833-827-9741

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Atumelnant for children with classic congenital adrenal hyperplasia (Balance-CAH)

  This study will test whether atumelnant is safe and helps control hormone levels in children aged 1 to under 18 with classic congenital adrenal hyperplasia.

  Recruiting at 50 sites Phase 2/3 Crinetics Pharmaceuticals Inc. · Los Angeles, California and 52 other locations · NCT07159841

• Long-term evaluation of atumelnant for congenital adrenal hyperplasia

  This study is testing if a new treatment called atumelnant is safe and effective for people with congenital adrenal hyperplasia who have already participated in a related study.

  Recruiting at 10 sites Phase 2 Crinetics Pharmaceuticals Inc. · Minneapolis, Minnesota and 12 other locations · NCT06712823

• Pediatric Congenital Adrenal Hyperplasia: Long-Term Outcomes and Feelings of Regret

  This study looks at adults who had classic CAH from 21-hydroxylase deficiency as children to see if early surgeries and management choices are linked to long‑term satisfaction or regret.

  Recruiting University Hospital, Lille · Lille · NCT07781267

• Crinecerfont safety testing in babies with classic CAH under 4 years old

  This study tests whether crinecerfont is safe and tolerable in children under 4 years with classic CAH who have been on hydrocortisone.

  Recruiting at 11 sites Phase 2 Neurocrine Biosciences · San Francisco, California and 10 other locations · NCT07536269

• Registry for male patients with congenital adrenal hyperplasia

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  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna · NCT06754423

• Registry for Rare Diseases

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  Recruiting Hospital Italiano de Buenos Aires · Buenos Aires, Buenos Aires · NCT06573723

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.