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Looking for participantsPhase3

A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia

Sponsor: Crinetics Pharmaceuticals Inc.

NCT ID: NCT07144163

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Atumelnant (drug), Placebo (drug)
How long the study runs
Study runs about 17 months (dates as stated)
About the drug or intervention
Atumelnant — drug: Atumelnant, tablets, once daily by mouth · Placebo — drug: Placebo, tablets, once daily by mouth
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a medicine called atumelnant in adults aged 18 to under 75 with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency. CAH is a condition the body is born with that affects hormone production. The study is run by Crinetics Pharmaceuticals Inc.

Who can take part

  • Adults aged 18 to under 75, male or female
  • Classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency, confirmed by the study doctor
  • Able to understand and follow the study plan and treatment
  • Blood levels of a hormone called androstenedione (A4) and glucocorticoid (steroid replacement) doses that fit the study rules
  • On a stable dose of steroid replacement medicine (such as hydrocortisone or prednisolone) for at least 2 months before joining
  • If taking fludrocortisone (a salt-balancing medicine), the dose must have been stable for at least 1 month before joining, with normal sodium and potassium levels
  • If taking oestrogen therapy, the dose must have been stable for at least 3 months before joining

Who may not be able to

  • A type of CAH other than classic 21-hydroxylase deficiency
  • Past removal of both adrenal glands, hypopituitarism, or another condition needing long-term steroid treatment
  • Another significant health condition or abnormal test results, in the study doctor's view
  • A mental health condition that makes it hard to understand the study or follow instructions
  • History of cancer, apart from fully treated skin cancers (basal or squamous cell) or cured cervical carcinoma in situ
  • Pregnant or breastfeeding women, and anyone unwilling to use highly effective contraception
  • Known or suspected allergy to atumelnant or its ingredients
  • Higher risk of adrenal insufficiency (when the body makes too little of certain hormones), in the study doctor's view
  • Severe erythrocytosis (too many red blood cells), in the study doctor's view
  • Having taken atumelnant before

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about study visits, how long it lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 74 Years
Who
All
Number of participants
150
Started
2025-12-11
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for congenital adrenal hyperplasia
  • • Phase3 - 150 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 74 Years
  • • Diagnosed with congenital adrenal hyperplasia

Where?

  • • Cardiff - Crinetics Study Site
  • • London - Crinetics Study Site
  • • Manchester - Crinetics Study Site
  • • Sheffield - Crinetics Study Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study in adult participants (male or female age ≥18 to \<75 years) with classic CAH due to 21-OHD who have been on a stable regimen of GCs for at least 2 months to evaluate efficacy, safety, PK, and PD of atumelnant administered once per day. Following a 3- to 6-week Screening Period, eligible participants will enter the Treatment Period where they will be randomly assigned in a 2:1 ratio to receive either atumelnant 80 mg once daily (with an option for dose escalation to 120 mg once daily at Week 20) or placebo. A total of approximately 150 participants may be enrolled in the study.

Congenital Adrenal HyperplasiaClassic Congenital Adrenal Hyperplasia

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 74 Years
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓Have classic CAH due to 21-OHD confirmed by the Investigator.
  • ✓Participants with Visit 2 levels of morning serum A4 as follows:
  • ✓A4 \>ULN and treated with \<11 mg/m2/day (physiologic) GC doses

Who cannot take part

  • ✗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...
  • ✗History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
See the full 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 Is This Study? (4 UK sites)

Crinetics Study Site

Cardiff CF14 4xW, United Kingdom

Recruiting

Crinetics Study Site

London NW1 2PG, United Kingdom

Recruiting

Crinetics Study Site

Manchester M20 4BX, United Kingdom

Recruiting

Crinetics Study Site

Sheffield S10 2JF, United Kingdom

Recruiting

How to Get in Touch

Crinetics Clinical Trials

Sponsor contact

CONTACT

833-827-9741 clinicaltrials@crinetics.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05