RecruitingPhase 3

A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia

United States, Argentina150 participantsStarted 2025-12-11

Plain-language 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.

Age range18 Years – 74 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female, between ≥18 to \<75 years of age at the time of signing the ICF.
✓. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
✓. Have classic CAH due to 21-OHD confirmed by the Investigator.
✓. Participants with Visit 2 levels of morning serum A4 as follows:
✓. 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.
✓. 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.
✓. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.

✕. Diagnosis of any form of CAH other than classic 21-OHD.
✕. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.
✕. Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.
✕. 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.
✕. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
✕. 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.
✕. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.
✕. Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.

Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement.

Timeframe: Week 32

NCT IDNCT07144163

SponsorCrinetics Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05

Crinetics Clinical Trials

Who can participate

Age range18 Years – 74 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female, between ≥18 to \<75 years of age at the time of signing the ICF.
✓. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
✓. Have classic CAH due to 21-OHD confirmed by the Investigator.
✓. Participants with Visit 2 levels of morning serum A4 as follows:
✓. 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.
✓. 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.
✓. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.

✕. Diagnosis of any form of CAH other than classic 21-OHD.
✕. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.
✕. Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.
✕. 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.
✕. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
✕. 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.
✕. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.
✕. Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.