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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (4 UK sites)
Crinetics Study Site
Cardiff CF14 4xW, United Kingdom
Crinetics Study Site
London NW1 2PG, United Kingdom
Crinetics Study Site
Manchester M20 4BX, United Kingdom
Crinetics Study Site
Sheffield S10 2JF, United Kingdom
How to Get in Touch
Crinetics Clinical Trials
Sponsor contactCONTACT
