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Clinical Trials in the UK / NCT07144163
Recruiting Phase 3

A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia

NCT07144163 · tracked via the Priya Life Science UK tracker
Sponsor
Crinetics Pharmaceuticals Inc.
Phase
Phase 3
Started
2025-12-11
Last updated
2026-09-02

Condition(s) studied

Congenital Adrenal HyperplasiaClassic Congenital Adrenal Hyperplasia

Investigational drug(s) / intervention(s)

AtumelnantPlacebo

Atumelnant: Atumelnant, tablets, once daily by mouth

Placebo: Placebo, tablets, once daily by mouth

Study 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

Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
Crinetics Study Site Los Angeles California Recruiting
Crinetics Study Site Aurora Colorado Recruiting
Crinetics Study Site Gainesville Florida Recruiting
Crinetics Study Site Atlanta Georgia Recruiting
Crinetics Study Site Chicago Illinois Recruiting
Crinetics Study Site Baltimore Maryland Recruiting
Crinetics Study Site Ann Arbor Michigan Recruiting
Crinetics Study Site Minneapolis Minnesota Recruiting
Crinetics Study Site Rochester Minnesota Recruiting
Crinetics Study Site Philadelphia Pennsylvania Recruiting
Crinetics Study Site Pittsburgh Pennsylvania Recruiting
Crinetics Study Site Dallas Texas Recruiting
Crinetics Study Site Milwaukee Wisconsin Recruiting
Crinetics Study Site Buenos Aires Buenos Aires F.D. Recruiting
Crinetics Study Site Buenos Aires Buenos Aires F.D. Recruiting
Crinetics Study Site CABA Buenos Aires F.D. Recruiting
Crinetics Study Site CABA Buenos Aires F.D. Recruiting
Crinetics Study Site Córdoba Córdoba Province Recruiting
Crinetics Study Site Herston Queensland Recruiting
Crinetics Study Site Woolloongabba Queensland Recruiting
Crinetics Study Site Adelaide South Australia Recruiting
Crinetics Study Site Parkville Victoria Recruiting
Crinetics Study Site Nedlands Western Australia Recruiting
Crinetics Study Site Graz Styria Recruiting
Crinetics Study Site Vienna Austria Recruiting
Crinetics Study Site Fortaleza Ceará Recruiting
Crinetics Study Site Curitiba Paraná Recruiting
Crinetics Study Site Rio de Janeiro Rio de Janeiro Recruiting
Crinetics Study Site Rio de Janeiro Rio de Janeiro Recruiting
Crinetics Study Site Porto Alegre Rio Grande do Sul Recruiting
Crinetics Study Site Botucatu São Paulo Recruiting
Crinetics Study Site Ribeirão Preto São Paulo Recruiting
Crinetics Study Site São Paulo São Paulo Recruiting
Crinetics Study Site São Paulo São Paulo Recruiting
Crinetics Study Site Angers France Recruiting
Crinetics Study Site Bron France Recruiting
Crinetics Study Site Nantes France Recruiting
Crinetics Study Site Paris France Recruiting
Crinetics Study Site Pessac France Recruiting
Crinetics Study Site Vandœuvre-lès-Nancy France Recruiting

+ 28 more sites — see the full list on the official registry below.

More Crinetics Pharmaceuticals Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07144163 on ClinicalTrials.gov ↗ ← All trials in the UK