Congenital Adrenal HyperplasiaPhase 2NCT05907291
Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)
A Phase 2 study testing atumelnant (CRN04894) in people with Congenital Adrenal Hyperplasia and Classic Congenital Adrenal Hyperplasia, run by Crinetics Pharmaceuticals Inc. at 27 sites in 7 countries.
Trial summary
The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of atumelnant (CRN04894) in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency. Read more about this study
- Who is it for?
- Ages 16 to 75 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
- 38 participants
- Where
- 27 sitesin 7 countries
- Study dates
- 3 Jul 2023to 22 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female participants ≥18 to 75 years of age at the time of signing the Informed Consent Form (ICF). Participants ≥16 years of age may be included in sites located in the United States
- Classic 21-hydroxylase deficiency
- On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone)
- Compliance with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen during the Screening Period
- Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent). For Cohort 4, a mean daily dose of ≥11 mg/m²/day of hydrocortisone or hydrocortisone equivalents will be used for inclusion
- If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening
Who cannot join
- Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency
- Dexamethasone use within 30 days of Screening for Cohorts 1-3. In Cohort 4, dexamethasone is permitted
- History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy
- Night shift workers or any other reason for abnormal sleep/wake cycles
- Clinically significant unstable medical condition or chronic disease other than CAH
- History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening
Show all 15Show fewer
- Diabetes mellitus treated with insulin for less than 6 weeks prior to Screening, or with change in total daily insulin dose by >15% within 6 weeks prior to Screening
- Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%(≥69 mmol/mL), or estimated HbA1c based on fructosamine if HbA1c is not evaluable (eg, due to hemoglobinopathies)
- Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening
- History of unstable angina or acute myocardial infarction within 12 weeks prior to Screening or other clinically significant cardiac disease at the time of Screening
- History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ
- Pregnant or lactating
- Known history of illicit drug or alcohol abuse within the last year
- Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride, cyproterone acetate, flutamide)
- Use of testosterone, androgen-containing supplements, aromatase inhibitors, or growth hormone
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
United States8 sites
Crinetics Study Site
Ann Arbor, Michigan, 48109
Crinetics Study Site
Cleveland, Ohio, 44195
Crinetics Study Site
East Providence, Rhode Island, 02915
Crinetics Study Site
Minneapolis, Minnesota, 55454
Crinetics Study Site
Morehead City, North Carolina, 28557
Crinetics Study Site
Pasadena, California, 91105
Crinetics Study Site
Philadelphia, Pennsylvania, 19104
Crinetics Study Site
St Louis, Missouri, 63110
Brazil8 sites
Crinetics Study Site
Botucatu, São Paulo, 18618-686
Crinetics Study Site
Curitiba, Paraná, 80030-110
Crinetics Study Site
Porto Alegre, Rio Grande do Sul, 90410-000
Crinetics Study Site
Ribeirão Preto, São Paulo, 14051-140
Crinetics Study Site
Rio de Janeiro, 20231-092
Crinetics Study Site
Rio de Janeiro, 20551-030
Crinetics Study Site
São Paulo, 04024-002
Crinetics Study Site
São Paulo, 05403-000
Italy3 sites
Crinetics Study Site
Naples, 80131
Crinetics Study Site
Roma, 00161
Crinetics Study Site
Rozzano, 20089
United Kingdom3 sites
Crinetics Study Site
Coventry, West Midlands, CV22DX
Crinetics Study Site
London, NW1 2PG
Crinetics Study Site
Sheffield, South Yorkshire, S10 2RX
Argentina2 sites
Crinetics Study Site
Buenos Aires, C1180
Crinetics Study Site
Córdoba, Córdoba Province, 5000
India2 sites
Crinetics Study Site
Bangalore, Karnataka, 560054
Crinetics Study Site
Vellore, Tamil Nadu, 632004
About this study
Official title: A 12-week, Phase 2 Open-label, Sequential Dose Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 Treatment in Participants With Congenital Adrenal Hyperplasia (TouCAHn)
The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of atumelnant (CRN04894) in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.
Read the detailed description
This Phase 2, open-label, sequential dose cohort study will evaluate the efficacy, safety, PK, and PD of atumelnant (CRN04894) when administered for 12 weeks in participants with CAH caused by 21-hydroxylase deficiency. Up to 42 participants will be enrolled in the study.
- Being tested
- atumelnant (CRN04894)
- Keywords
- Congenital Adrenal Hyperplasia, CAH, TouCAHn, 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) antagonist.
| Study group | Role | What they receive |
|---|---|---|
| Sequential Dose | Experimental | Sequential, open-label, 12-week fixed-dose cohorts. Receives: Drug: atumelnant (CRN04894) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Morning (Before 11:00) Serum Androstenedione (A4) PM Dosing
A4 is the principal biochemical measure of disease activity in adult CAH. Blood samples were collected for the measurement of serum concentration of A4 prior to glucocorticoid administration. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was obtained by subtracting post-baseline visit value minus baseline value.
Measured: Baseline and Week 12
Change From Baseline in Morning (Before 11:00) Serum Androstenedione (A4) AM Dosing
A4 is the principal biochemical measure of disease activity in adult CAH. Blood samples were collected for the measurement of serum concentration of A4 prior to glucocorticoid administration. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was obtained by subtracting post-baseline visit value minus baseline value.
Measured: Baseline and Week 12
Number of Participants Reporting of Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events Leading to Discontinuation Throughout the Study
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were collected in the full analysis set which consisted of all participants who received at least one dose of study drug. A serious AE is defined by its severe clinical consequences: it is any event that results in death, is life-threatening, requires inpatient hospitalization, results in persistent disability, or requires medical intervention to prevent these outcomes.
Measured: From Day 1 to Up to Week 16 (End of study)
Secondary outcomes (2)
Change From Baseline in Morning (Before 11:00) Serum 17-hydroxyprogesterone (17-OHP) PM Dosing
Elevated levels of the immediate enzyme substrate 17-OHP are indicative of CAH. The secondary efficacy endpoint was change from baseline in morning serum 17-OHP at Week 12. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was analyzed using the mean at baseline and at each visit, for all participants with both baseline and the corresponding visit values.
Measured: Baseline and Week 12
Change From Baseline in Morning (Before 11:00) Serum 17-hydroxyprogesterone (17-OHP) AM Dosing
Elevated levels of the immediate enzyme substrate 17-OHP are indicative of CAH. The secondary efficacy endpoint was change from baseline in morning serum 17-OHP at Week 12. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was analyzed using the mean at baseline and at each visit, for all participants with both baseline and the corresponding visit values.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start3 Jul 2023
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907291
- Sponsor's protocol ID
- CRN04894-03
- Other IDs
- 2023-503488-40-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 8 Jun 2023
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Phase 2 Open-label, Sequential Dose Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 Treatment in Participants With Congenital Adrenal Hyperplasia (TouCAHn)
- ClinicalTrials.gov ID
- NCT05907291
- Acronym / sponsor ID
- CRN04894-03
- Keywords
- Congenital Adrenal Hyperplasia, CAH, TouCAHn, CRN04894, atumelnant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Posted 10 Sep 2026
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 Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of atumelnant (CRN04894) in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.
Detailed description
This Phase 2, open-label, sequential dose cohort study will evaluate the efficacy, safety, PK, and PD of atumelnant (CRN04894) when administered for 12 weeks in participants with CAH caused by 21-hydroxylase deficiency. Up to 42 participants will be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential Dose | Experimental | Drug: atumelnant (CRN04894)Sequential, open-label, 12-week fixed-dose cohorts. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants ≥18 to 75 years of age at the time of signing the Informed Consent Form (ICF). Participants ≥16 years of age may be included in sites located in the United States
- Classic 21-hydroxylase deficiency
- On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone)
- Compliance with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen during the Screening Period
- Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent). For Cohort 4, a mean daily dose of ≥11 mg/m²/day of hydrocortisone or hydrocortisone equivalents will be used for inclusion
Key exclusion criteria (15 listed)
- Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency
- Dexamethasone use within 30 days of Screening for Cohorts 1-3. In Cohort 4, dexamethasone is permitted
- History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy
- Night shift workers or any other reason for abnormal sleep/wake cycles
- Clinically significant unstable medical condition or chronic disease other than CAH
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) antagonist. | Drug | Sequential Dose |
Primary outcome
Change From Baseline in Morning (Before 11:00) Serum Androstenedione (A4) PM Dosing
Time frame: Baseline and Week 12
A4 is the principal biochemical measure of disease activity in adult CAH. Blood samples were collected for the measurement of serum concentration of A4 prior to glucocorticoid administration. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was obtained by subtracting post-baseline visit value minus baseline value.
Change From Baseline in Morning (Before 11:00) Serum Androstenedione (A4) AM Dosing
Time frame: Baseline and Week 12
A4 is the principal biochemical measure of disease activity in adult CAH. Blood samples were collected for the measurement of serum concentration of A4 prior to glucocorticoid administration. Baseline is defined as the last non-missing morning window value prior to or on the same day as the first dose date of atumelnant. Change from baseline was obtained by subtracting post-baseline visit value minus baseline value.
Number of Participants Reporting of Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events Leading to Discontinuation Throughout the Study
Time frame: From Day 1 to Up to Week 16 (End of study)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were collected in the full analysis set which consisted of all participants who received at least one dose of study drug. A serious AE is defined by its severe clinical consequences: it is any event that results in death, is life-threatening, requires inpatient hospitalization, results in persistent disability, or requires medical intervention to prevent these outcomes.
2 secondary outcomes
Change From Baseline in Morning (Before 11:00) Serum 17-hydroxyprogesterone (17-OHP) PM Dosing
Time frame: Baseline and Week 12
Change From Baseline in Morning (Before 11:00) Serum 17-hydroxyprogesterone (17-OHP) AM Dosing
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 7 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 27 sites in 7 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 6 inclusion and 15 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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Brazil, Italy, United Kingdom, Argentina and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 10 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Morning (Before 11:00) Serum Androstenedione (A4) PM Dosing (time frame: Baseline and Week 12). The study lists 3 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 10 Sep 2026.