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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07144163




Registration number
NCT07144163
Ethics application status
Date submitted
20/08/2025
Date registered
27/08/2025
Date last updated
5/09/2025

Titles & IDs
Public title
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
Scientific 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)
Secondary ID [1] 0 0
2024-519579-24-00
Secondary ID [2] 0 0
CRN04894-12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Adrenal Hyperplasia 0 0
Classic Congenital Adrenal Hyperplasia 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atumelnant
Treatment: Drugs - Placebo

Experimental: Treatment - Atumelnant tablet, administered orally, once daily for 32 weeks.

Placebo comparator: Placebo - Matching placebo, administered orally, once daily for 32 weeks.


Treatment: Drugs: Atumelnant
Atumelnant, tablets, once daily by mouth

Treatment: Drugs: Placebo
Placebo, tablets, once daily by mouth
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with morning post-GC A4 = ULN who are on physiologic GC replacement.
Timepoint [1] 0 0
Week 32
Secondary outcome [1] 0 0
Percent change from baseline of morning pre-GC A4
Timepoint [1] 0 0
Week 2
Secondary outcome [2] 0 0
Percent change from baseline of morning pre-GC 17-OHP
Timepoint [2] 0 0
Week 32
Secondary outcome [3] 0 0
Proportion of participants with morning pre-GC A4 = ULN who are on physiologic GC replacement
Timepoint [3] 0 0
Week 32
Secondary outcome [4] 0 0
Percent change from baseline in GC daily dose when morning post-GC A4 = ULN
Timepoint [4] 0 0
Week 32

Eligibility
Key inclusion criteria
1. Male or female, between =18 to <75 years of age at the time of signing the ICF.
2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
3. Have classic CAH due to 21-OHD confirmed by the Investigator and approved by the Medical Monitor.
4. Participants with levels of morning serum A4 as follows:

* A4 >ULN and treated with <11 mg/m2/day (physiologic) GC doses
* OR normal A4 (above mid-range to =ULN) and treated with =15 mg/m2/day GC doses
* OR A4 >ULN and treated with =11 mg/m2/day GC doses.
5. 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.
6. If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 2 months prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range.
7. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of any form of CAH other than classic 21-OHD.
2. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.
3. Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.
4. 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.
5. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
6. 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.
7. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.
8. Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.
9. Severe erythrocytosis as judged by the Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Crinetics Study Site - Herston
Recruitment hospital [2] 0 0
Crinetics Study Site - Woolloongabba
Recruitment hospital [3] 0 0
Crinetics Study Site - Adelaide
Recruitment hospital [4] 0 0
Crinetics Study Site - Parkville
Recruitment hospital [5] 0 0
Crinetics Study Site - Nedlands
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Crinetics Pharmaceuticals Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Crinetics Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
833-827-9741
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07144163