ClinicalTrials.gov record NCT07144163
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
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)
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 3, randomized, double-blind, placebo-controlled study evaluates once-daily atumelnant in adults with classic congenital adrenal hyperplasia (due to 21‑hydroxylase deficiency). About 150 participants will be randomized 2:1 to atumelnant 80 mg once daily (with an option to increase to 120 mg at Week 20) or matching placebo; treatment lasts 32 weeks and the study measures hormone levels, safety, and drug behavior in the body.
What it is studying. The study is testing whether daily atumelnant affects hormone control (including morning androstenedione and 17‑hydroxyprogesterone), how it changes glucocorticoid dosing patterns, and the drug's safety and pharmacokinetics/pharmacodynamics (how the drug acts in the body).
What the researchers hope to learn. To determine whether atumelnant changes hormone measures used to assess control of classic CAH, to evaluate effects on glucocorticoid dosing, and to characterize safety and the drug's pharmacokinetics and pharmacodynamics in adults with classic CAH.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Atumelnant
- Placebo
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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:
- 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.
- 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.
Exclusion criteria
- 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.
- Severe erythrocytosis as judged by the Investigator.
- Use of atumelnant prior to screening.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After a 3–6 week screening period, participants are randomized (2:1) to take a daily oral tablet of atumelnant (80 mg once daily, with an option to escalate to 120 mg at Week 20) or matching placebo for 32 weeks. Participation includes regular clinic visits for safety checks, blood samples for hormone levels and pharmacokinetic/pharmacodynamic testing (morning A4 and 17‑OHP are central measures), and ongoing monitoring while you remain on your stable GC replacement. The study is masked so you and most study staff will not know your assignment. The record does not list any invasive procedures such as biopsies or spinal taps.
How the study is structured. A Phase 3 randomized, triple‑masked (participants, study staff, and investigators blinded), parallel-group trial. Participants are assigned 2:1 to receive oral atumelnant or matching placebo once daily for 32 weeks; dose escalation from 80 mg to 120 mg is allowed at Week 20 for those on active drug. The study tracks hormone tests, safety assessments, and drug-level measurements.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
- The listed sites are in Argentina, Australia, Austria, Brazil, Canada, France, Germany, Italy, Japan, Netherlands, Poland, Saudi Arabia, Sweden, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on congenital adrenal hyperplasia
Important dates
- Study start
- Dec 11, 2025
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- Target enrollment
- 150 participants (estimated)
- Last updated on registry
- Sep 30, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Crinetics Clinical Trials 📞 833-827-9741 ✉ clinicaltrials@crinetics.com
Participating sites (72)
- Crinetics Study SiteRecruiting
Los Angeles, California, 90027 · United States
- Crinetics Study SiteRecruiting
Aurora, Colorado, 80045 · United States
- Crinetics Study SiteRecruiting
Gainesville, Florida, 32610 · United States
- Crinetics Study SiteRecruiting
Atlanta, Georgia, 30322 · United States
- Crinetics Study SiteRecruiting
Chicago, Illinois, 60611 · United States
- Crinetics Study SiteRecruiting
Baltimore, Maryland, 21287 · United States
- Crinetics Study SiteRecruiting
Ann Arbor, Michigan, 48109 · United States
- Crinetics Study SiteRecruiting
Minneapolis, Minnesota, 55417 · United States
- Crinetics Study SiteRecruiting
Rochester, Minnesota, 55905 · United States
- Crinetics Study SiteRecruiting
Philadelphia, Pennsylvania, 19104 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- PK
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- ICF
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- ULN
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- prior to Screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- prednisolone
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- double-blind
- Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
- placebo-controlled
- A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
- stable regimen
- A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
- 2:1
- How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
- dose escalation
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- placebo
- A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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