Congenital Adrenal HyperplasiaPhase 3NCT07144163
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
A Phase 3 study testing Atumelnant in people with Congenital Adrenal Hyperplasia and Classic Congenital Adrenal Hyperplasia, run by Crinetics Pharmaceuticals Inc. at 81 sites in 15 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
- What is being tested?
- Atumelnant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 81 sitesin 15 countries
- Study dates
- 11 Dec 2025to May 2027
- Phase
- Phase 3
- 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
81 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
81 sites in 15 countries
United States15 sites, 15 recruiting
- Recruiting
Crinetics Study Site
Ann Arbor, Michigan, 48109
- Recruiting
Crinetics Study Site
Atlanta, Georgia, 30322
- Recruiting
Crinetics Study Site
Aurora, Colorado, 80045
- Recruiting
Crinetics Study Site
Baltimore, Maryland, 21287
- Recruiting
Crinetics Study Site
Charlottesville, Virginia, 22903
- Recruiting
Crinetics Study Site
Chicago, Illinois, 60611
- Recruiting
Crinetics Study Site
Dallas, Texas, 75390
- Recruiting
Crinetics Study Site
Gainesville, Florida, 32610
- Recruiting
Crinetics Study Site
Los Angeles, California, 90027
- Recruiting
Crinetics Study Site
Milwaukee, Wisconsin, 53226
- Recruiting
Crinetics Study Site
Minneapolis, Minnesota, 55417
- Recruiting
Crinetics Study Site
New Brunswick, New Jersey, 08901
- Recruiting
Crinetics Study Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Crinetics Study Site
Pittsburgh, Pennsylvania, 15213
- Recruiting
Crinetics Study Site
Rochester, Minnesota, 55905
Brazil12 sites, 12 recruiting
- Recruiting
Crinetics Study Site
Belo Horizonte, Minas Gerais, 30130-100
- Recruiting
Crinetics Study Site
Botucatu, São Paulo, 18618-686
- Recruiting
Crinetics Study Site
Brasília, Federal District, 71625-175
- Recruiting
Crinetics Study Site
Campinas, São Paulo, 13083-887
- Recruiting
Crinetics Study Site
Curitiba, Paraná, 80030-110
- Recruiting
Crinetics Study Site
Fortaleza, Ceará, 60430-275
- Recruiting
Crinetics Study Site
Porto Alegre, Rio Grande do Sul, 90410-000
- Recruiting
Crinetics Study Site
Ribeirão Preto, São Paulo, 14051-140
- Recruiting
Crinetics Study Site
Rio de Janeiro, Rio de Janeiro, 20231-092
- Recruiting
Crinetics Study Site
Rio de Janeiro, Rio de Janeiro, 20551-030
- Recruiting
Crinetics Study Site
São Paulo, São Paulo, 04024-002
- Recruiting
Crinetics Study Site
São Paulo, São Paulo, 05403-000
Italy9 sites, 9 recruiting
- Recruiting
Crinetics Study Site
Genova, Genova, 16132
- Recruiting
Crinetics Study Site
Milan, Milano, 20132
- Recruiting
Crinetics Study Site
Milan, Milano, 20149
- Recruiting
Crinetics Study Site
Modena, Modena, 41126
- Recruiting
Crinetics Study Site
Naples, 80131
- Recruiting
Crinetics Study Site
Padova, Padova, 35128
- Recruiting
Crinetics Study Site
Palermo, Palermo, 90127
- Recruiting
Crinetics Study Site
Roma, 00161
- Recruiting
Crinetics Study Site
Rozzano, Milano, 20089
Japan8 sites, 8 recruiting
- Recruiting
Crinetics Study Site
Asahikawa, Hokkaido, 078-8510
- Recruiting
Crinetics Study Site
Bunkyo-ku, Tokyo, 113-8519
- Recruiting
Crinetics Study Site
Fuchu-shi, Tokyo, 183-8561
- Recruiting
Crinetics Study Site
Hiroshima, Hiroshima, 734-8551
- Recruiting
Crinetics Study Site
Kobe, Hyōgo, 650-0017
- Recruiting
Crinetics Study Site
Setagaya-ku, Tokyo, 157-8535
- Recruiting
Crinetics Study Site
Shinjuku-ku, Tokyo, 162-8655
- Recruiting
Crinetics Study Site
Shinjuku-ku, Tokyo, 162-8666
France6 sites, 6 recruiting
- Recruiting
Crinetics Study Site
Angers, 49933
- Recruiting
Crinetics Study Site
Bron, 69500
- Recruiting
Crinetics Study Site
Nantes, 44093 Cedex 1
- Recruiting
Crinetics Study Site
Paris, 75013
- Recruiting
Crinetics Study Site
Pessac, 33604
- Recruiting
Crinetics Study Site
Vandœuvre-lès-Nancy, 54500
Argentina5 sites, 5 recruiting
- Recruiting
Crinetics Study Site
Buenos Aires, Buenos Aires F.D., 1405
- Recruiting
Crinetics Study Site
Buenos Aires, Buenos Aires F.D., C1012AAR
- Recruiting
Crinetics Study Site
CABA, Buenos Aires F.D., 1119
- Recruiting
Crinetics Study Site
CABA, Buenos Aires F.D., C1199ABB
- Recruiting
Crinetics Study Site
Córdoba, Córdoba Province, X5000JRD
Australia5 sites, 5 recruiting
- Recruiting
Crinetics Study Site
Adelaide, South Australia, 5000
- Recruiting
Crinetics Study Site
Herston, Queensland, 4029
- Recruiting
Crinetics Study Site
Nedlands, Western Australia, 6009
- Recruiting
Crinetics Study Site
Parkville, Victoria, 3050
- Recruiting
Crinetics Study Site
Woolloongabba, Queensland, 4102
United Kingdom5 sites, 5 recruiting
- Recruiting
Crinetics Study Site
Birmingham, B15 2GW
- Recruiting
Crinetics Study Site
Cardiff, Wales, CF14 4xW
- Recruiting
Crinetics Study Site
London, NW1 2PG
- Recruiting
Crinetics Study Site
Manchester, M20 4BX
- Recruiting
Crinetics Study Site
Sheffield, S10 2JF
Saudi Arabia4 sites, 4 recruiting
- Recruiting
Crinetics Study Site
Dammam, Eastern Province, 32253
- Recruiting
Crinetics Study Site
Jeddah, 21423
- Recruiting
Crinetics Study Site
Riyadh, Riyadh Region, 11211
- Recruiting
Crinetics Study Site
Riyadh, Riyadh Region, 11421
Poland3 sites, 3 recruiting
- Recruiting
Crinetics Study Site
Lodz, Łódź Voivodeship, 93-338
- Recruiting
Crinetics Study Site
Poznan, Greater Poland Voivodeship, 60-354
- Recruiting
Crinetics Study Site
Warsaw, Masovian Voivodeship, 00-189
Austria2 sites, 2 recruiting
- Recruiting
Crinetics Study Site
Graz, Styria, 8036
- Recruiting
Crinetics Study Site
Vienna, 1090
Germany2 sites, 2 recruiting
- Recruiting
Crinetics Study Site
Munich, Bavaria, 80336
- Recruiting
Crinetics Study Site
Würzburg, 97080
Netherlands2 sites, 2 recruiting
- Recruiting
Crinetics Study Site
Leiden, South Holland, 2333 ZA
- Recruiting
Crinetics Study Site
Nijmegen, 6525 GA
Sweden2 sites, 2 recruiting
- Recruiting
Crinetics Study Site
Gothenburg, 413 46
- Recruiting
Crinetics Study Site
Stockholm, 171 76
Canada1 site, 1 recruiting
- Recruiting
Crinetics Study Site
Halifax, Nova Scotia, B3H 2Y9
About this study
Official title: 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)
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.
Read the detailed description
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.
- Being tested
- Atumelnant, Placebo
- Keywords
- Congenital Adrenal Hyperplasia, CAH, CRN04894, Atumelnant, Adult, Calm-CAH
- 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.
AtumelnantDrug
Also called CRN04894
Atumelnant, tablets, once daily by mouth
PlaceboDrug
Placebo, tablets, once daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Atumelnant tablet, administered orally, once daily for 32 weeks. Receives: Drug: Atumelnant |
| Placebo | Placebo comparator | Matching placebo, administered orally, once daily for 32 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement.
Measured: Week 32
Secondary outcomes (4)
Percent change from baseline of morning pre-GC A4
Measured: Week 2
Percent change from baseline of morning pre-GC 17-OHP
Measured: Week 32
Proportion of participants with morning pre-GC A4 ≤ ULN who are on physiologic GC replacement
Measured: Week 32
Percent change from baseline in GC daily dose when morning post-GC A4 ≤ ULN
Measured: Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start11 Dec 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 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
- NCT07144163
- Sponsor's protocol ID
- CRN04894-12
- Other IDs
- 2024-519579-24-00
- Status last verified
- May 2026
- First submitted
- 20 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07144163
- Acronym / sponsor ID
- CRN04894-12
- Keywords
- Congenital Adrenal Hyperplasia, CAH, CRN04894, Atumelnant, Adult, Calm-CAH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Aug 2025 (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 efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: AtumelnantAtumelnant tablet, administered orally, once daily for 32 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo, administered orally, once daily for 32 weeks. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| AtumelnantAlso: CRN04894Atumelnant, tablets, once daily by mouth | Drug | Treatment |
| PlaceboPlacebo, tablets, once daily by mouth | Drug | Placebo |
Primary outcome
Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement.
Time frame: Week 32
4 secondary outcomes
Percent change from baseline of morning pre-GC A4
Time frame: Week 2
Percent change from baseline of morning pre-GC 17-OHP
Time frame: Week 32
Proportion of participants with morning pre-GC A4 ≤ ULN who are on physiologic GC replacement
Time frame: Week 32
Percent change from baseline in GC daily dose when morning post-GC A4 ≤ ULN
Time frame: Week 32
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 5 Nov 2026.
- 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.
81 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atumelnant in people with Congenital Adrenal Hyperplasia and Classic Congenital Adrenal Hyperplasia, run by Crinetics Pharmaceuticals Inc. at 81 sites in 15 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 10 inclusion and 10 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, Brazil, Italy, Japan, France and 10 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement. (time frame: Week 32). 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 5 Nov 2026.