Congenital Adrenal HyperplasiaPhase 2CALM2-CAHNCT06712823
An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia
A Phase 2 study testing atumelnant (CRN04894) in people with Congenital Adrenal Hyperplasia and Classic Congenital Adrenal Hyperplasia, run by Crinetics Pharmaceuticals Inc. at 13 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894). Read more about this study
- Who is it for?
- Ages 16 to 74 years
- Conditions the study is for
- Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
- What is being tested?
- atumelnant (CRN04894)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 25 Feb 2025to Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
13 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 6 countries
Brazil5 sites, 5 recruiting
- Recruiting
Crinetics Study Site
Botucatu, São Paulo, 18618-686
- Recruiting
Crinetics Study Site
Curitiba, Paraná, 80030-110
- Recruiting
Crinetics Study Site
Porto Alegre, Rio Grande do Sul, 90410-000
- Recruiting
Crinetics Study Site
Rio de Janeiro, 20231-092
- Recruiting
Crinetics Study Site
São Paulo, 05403-000
United States3 sites
- Active, not recruiting
Crinetics Study Site, Minneapolis, Minnesota 55454
Minneapolis, Minnesota, 55455
- Active, not recruiting
Crinetics Study Site
Morehead City, North Carolina, 28557
- Active, not recruiting
Crinetics Study Site
Philadelphia, Pennsylvania, 19104
United Kingdom2 sites, 2 recruiting
- Recruiting
Crinetics Study Site
Birmingham, CV22DX
- Recruiting
Crinetics Study Site
London, NW1 2BU
Argentina1 site, 1 recruiting
- Recruiting
Crinetics Study Site
Córdoba, Córdoba Province, 5000
Germany1 site, 1 recruiting
- Recruiting
Crinetics Study Site
Munich, Bavaria, 80336
About this study
Official title: An Open-label, Long-term Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia (CALM2-CAH)
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).
Read the detailed description
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.
- Being tested
- atumelnant (CRN04894)
- Keywords
- Congenital Adrenal Hyperplasia, CAH, CRN04894, atumelnant
- Medical subject headings
- Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atumelnant (CRN04894)Drug
Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Open-label treatment period (up to 2 years). The maximum atumelnant dose permitted is not to exceed the highest atumelnant dose explored in a parent study for the indication. Receives: Drug: atumelnant (CRN04894) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (SAEs), adverse events of special interest (AESI [adrenal insufficiency]) and any adverse events (AEs) leading to discontinuation
Measured: Week 108
Incidence of glucocorticoid (GC) deficiency / adrenal insufficiency and adrenal crisis
Measured: Week 108
Incidence of hospitalizations related to congenital adrenal hyperplasia (CAH)
Measured: Week 108
Change from baseline in morning (before 11:00 AM) serum androstenedione (A4) over time
Measured: Week 108
Secondary outcomes (2)
Change from baseline in morning (before 11:00 AM) serum 17-hydroxyprogesterone (17-OHP) over time
Measured: Week 108
Change from baseline in daily glucocorticoid (GC) dose (hydrocortisone [HC] mg equivalents body surface area [BSA] adjusted) over time
Measured: Week 108
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start25 Feb 2025
- Primary completionJul 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712823
- Sponsor's protocol ID
- CRN04894-09
- Other IDs
- 2024-514846-35-00
- Acronym
- CALM2-CAH
- Status last verified
- Jun 2025
- First submitted
- 27 Nov 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Long-term Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia (CALM2-CAH)
- ClinicalTrials.gov ID
- NCT06712823
- Acronym / sponsor ID
- CALM2-CAH / CRN04894-09
- Keywords
- Congenital Adrenal Hyperplasia, CAH, CRN04894, atumelnant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: atumelnant (CRN04894)Open-label treatment period (up to 2 years). The maximum atumelnant dose permitted is not to exceed the highest atumelnant dose explored in a parent study for the indication. |
Who may qualify
- Ages
- 16 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Female participants who engage in heterosexual intercourse must:
- 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).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atumelnant (CRN04894)Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist. | Drug | Treatment |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (SAEs), adverse events of special interest (AESI [adrenal insufficiency]) and any adverse events (AEs) leading to discontinuation
Time frame: Week 108
Incidence of glucocorticoid (GC) deficiency / adrenal insufficiency and adrenal crisis
Time frame: Week 108
Incidence of hospitalizations related to congenital adrenal hyperplasia (CAH)
Time frame: Week 108
Change from baseline in morning (before 11:00 AM) serum androstenedione (A4) over time
Time frame: Week 108
2 secondary outcomes
Change from baseline in morning (before 11:00 AM) serum 17-hydroxyprogesterone (17-OHP) over time
Time frame: Week 108
Change from baseline in daily glucocorticoid (GC) dose (hydrocortisone [HC] mg equivalents body surface area [BSA] adjusted) over time
Time frame: Week 108
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Congenital Adrenal Hyperplasia
RecruitingPhase 2/3
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
RecruitingPhase 3
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing atumelnant (CRN04894) in people with Congenital Adrenal Hyperplasia and Classic Congenital Adrenal Hyperplasia, run by Crinetics Pharmaceuticals Inc. at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Brazil, United States, United Kingdom, Argentina, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crinetics Clinical Trials (833-827-9741, clinicaltrials@crinetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (SAEs), adverse events of special interest (AESI [adrenal insufficiency]) and any adverse events (AEs) leading to discontinuation (time frame: Week 108). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.