ClinicalTrials.gov record NCT06712823
An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia
An Open-label, Long-term Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia (CALM2-CAH)
AI summaryWhat this study is about, 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.
This open-label extension enrolls people with CAH who completed a parent Crinetics atumelnant study to continue atumelnant treatment. It follows participants on atumelnant for up to 2 years to collect safety data and measures of hormone levels and glucocorticoid use. About 150–200 participants may join.
What it is studying. The study is testing the long-term safety and tolerability of atumelnant and its effects on hormone measures (like androstenedione and 17‑OHP) and glucocorticoid dosing in people with CAH.
What the researchers hope to learn. To collect long-term data on safety and tolerability of atumelnant; to measure incidence of adrenal insufficiency/adrenal crisis and CAH-related hospitalizations; and to track changes in morning androstenedione, 17‑hydroxyprogesterone, and daily glucocorticoid dose over time.
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 long-term safety, tolerability, and efficacy of atumelnant (CRN04894).
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- atumelnant (CRN04894)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Participants are eligible to be included in the study only if all the following criteria apply:
- Participants with CAH who have completed the Treatment Period in a Crinetics parent atumelnant CAH study, and in the opinion of the Investigator had an acceptable benefit-risk assessment in the completed study and would benefit from continued dosing in this extension study.
- Group 1: Participants meeting the above criteria and did not have study drug administration interrupted between End of Trial (EOT) of the parent study and the commencement of the OLE study.
- Group 2: Participants meeting the above criteria but had study drug administration interrupted between EOT of the parent study and the commencement of the OLE study.
- Female participants who engage in heterosexual intercourse must:
- Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy for at least 3 months, or bilateral oophorectomy), OR
- Be postmenopausal with at least 1 year of amenorrhea. In participants with less than 1 year of amenorrhea, confirmation is required with 2 follicle-stimulating hormone (FSH) measurements. A documented, historical test result measured prior to Screening may be used as 1 of the 2 measurements. The FSH value should be ≥30 IU/L to confirm menopausal status, OR
- Agree to use a highly effective method of contraception from the beginning of Screening until at least 2 weeks after the last dose of study drug. Contraceptive use by men and women also should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Periodic abstinence (ie, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
- Male participants agree to use a condom when sexually active with a female partner of childbearing potential from Screening until at least 2 weeks after the last dose of study drug (or be surgically sterile [ie, vasectomy with a confirmed absence of sperm in ejaculate]; or agree to remain abstinent on a long-term and persistent basis). Male participants should also agree to not donate sperm for the duration of the study and until at least 2 weeks after the last dose of study drug.
- Participants are willing and able to give signed informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF).
- Participants are willing and able to comply with the study procedures as specified in the protocol and comply with the study treatment.
Exclusion criteria
- Participants are excluded from the study if any of the following criteria apply:
- Any medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the participant's safety or ability to complete the study.
- Participants have known history of (that is within the past 12 months), or current alcohol or drug abuse.
- Participants have any 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.
- Participants have a known allergy or hypersensitivity to any of the test materials or related compounds, including being at high risk of adrenal insufficiency as judged by the Investigator.
- 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.
- Participant is an employee or immediate family member of an employee of Crinetics.
- Participants who have been dosed with an investigational drug (other than atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to informed consent or plan to use an investigational drug in another study.
- Participants who have had an active malignant disease within the last 5 years prior to Screening excluding dermal squamous or basal cell carcinoma of the skin with complete local excision or resected cervical carcinoma in situ.
- Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- Specific for Participants Not Currently Receiving Atumelnant
- Participants with any clinically significant abnormal laboratory test during Screening or clinically significant concomitant disease other than CAH including but not limited to cardiovascular disease; moderate or severe renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.73 m2 using Chronic Kidney Epidemiology Collaboration [CKD-EPI] formula) at Screening; or Significant liver disease or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3× upper limit of normal (ULN), and/or total bilirubin >1.5×ULN during Screening. Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with total bilirubin <3.5 mg/dL (<51.3 μmol/L) will be permitted.
- Participants with a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
- Participants with a history of major surgery/surgical therapy for any cause within 4 weeks prior to Screening.
- Participants with poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5% (≥69 mmol/mL).
- Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening, as determined by the Investigator.
- Participant has an average (of 3 electrocardiograms [ECGs]) Fridericia's corrected QT (QTcF) interval >450 milliseconds (msec) (men) or >470 msec (women), time interval between P and R waves (PR interval) >220 msec, time interval of the QRS complex (QRS) interval >120 msec, second- or third-degree atrioventricular block, left bundle branch block, or hemiblock at Screening.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
This single-arm, long-term, open-label, study is designed to evaluate the safety, tolerability, and efficacy of atumelnant (CRN04894) in participants with congenital adrenal hyperplasia (CAH). Enrollment will be limited to individuals who completed a parent Crinetics atumelnant CAH study, and in the opinion of the Investigator had an acceptable benefit-risk assessment in the completed study and would benefit from continued dosing in this Open-Label Extension (OLE) study. A total of approximately 150 - 200 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.
Participants receive open-label oral atumelnant (CRN04894) for up to about 2 years. They will attend regular clinic visits for safety checks including blood tests (morning hormone measurements such as androstenedione and 17‑OHP are specified), ECGs, recording of glucocorticoid dose changes, and monitoring for adrenal insufficiency and adverse events. Hospitalizations related to CAH and any serious or treatment‑emergent adverse events will be tracked. Participants must provide informed consent and follow contraception and other study requirements.
How the study is structured. Single-group, open-label Phase 2 extension: people who completed a Crinetics parent atumelnant CAH study may continue receiving atumelnant in one treatment arm (no placebo or randomization). Treatment may continue for up to about 2 years; investigators will monitor safety, hormone levels, hospitalizations, and glucocorticoid dose over time.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Argentina, Brazil, Germany, Italy, 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
- Feb 25, 2025
- Primary completion
- July 2029 (estimated)
- Study completion
- August 2029 (estimated)
- Target enrollment
- 200 participants (estimated)
- Last updated on registry
- Jun 29, 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 (13)
- Crinetics Study Site, Minneapolis, Minnesota 55454Active Not Recruiting
Minneapolis, Minnesota, 55455 · United States
- Crinetics Study SiteActive Not Recruiting
Morehead City, North Carolina, 28557 · United States
- Crinetics Study SiteActive Not Recruiting
Philadelphia, Pennsylvania, 19104 · United States
- Crinetics Study SiteRecruiting
Córdoba, Córdoba Province, 5000 · Argentina
- Crinetics Study SiteRecruiting
Curitiba, Paraná, 80030-110 · Brazil
- Crinetics Study SiteRecruiting
Porto Alegre, Rio Grande do Sul, 90410-000 · Brazil
- Crinetics Study SiteRecruiting
Botucatu, São Paulo, 18618-686 · Brazil
- Crinetics Study SiteRecruiting
Rio de Janeiro, 20231-092 · Brazil
- Crinetics Study SiteRecruiting
São Paulo, 05403-000 · Brazil
- Crinetics Study SiteRecruiting
Munich, Bavaria, 80336 · Germany
Terms used on this page · explanations by MedicalUpdates.ai
- extension study
- A continuation study in which participants who completed an earlier study can keep receiving the treatment, usually with everyone knowing what they are given.
- study drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- prior to Screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- 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.
- informed consent
- 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.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- estimated glomerular filtration rate
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- upper limit of normal
- 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.
- glucocorticoid
- 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.
- QTcF
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- 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.
- single-arm
- All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- Enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
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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