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A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia

RecruitingPhase 3

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)

Who can join

Ages 18 to 74 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Crinetics Pharmaceuticals Inc. · Participants: 150 · Started: Dec 11, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07144163

Locations in the U.S.

CaliforniaCrinetics Study Site, Los Angeles
ColoradoCrinetics Study Site, Aurora
FloridaCrinetics Study Site, Gainesville
GeorgiaCrinetics Study Site, Atlanta
IllinoisCrinetics Study Site, Chicago
MarylandCrinetics Study Site, Baltimore
MichiganCrinetics Study Site, Ann Arbor
MinnesotaCrinetics Study Site, Minneapolis
Crinetics Study Site, Rochester
PennsylvaniaCrinetics Study Site, Philadelphia
Crinetics Study Site, Pittsburgh
TexasCrinetics Study Site, Dallas
WisconsinCrinetics Study Site, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.