Cushing SyndromePhase 1/2NCT05804669
A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome
A Phase 1/2 study testing atumelnant in people with Cushing Syndrome and Cushing Disease, run by Crinetics Pharmaceuticals Inc. at 1 site in United States.
Trial summary
A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone [ACTH] receptor antagonist) in participants with ACTH-dependent Cushing's… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Syndrome, Cushing Disease, Ectopic ACTH Syndrome
- What is being tested?
- atumelnant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 8 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female, aged 18 years or more
- Evidence of chronic 'active' ACTH-dependent Cushing's syndrome
- Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1
- Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to Investigator's judgment. Participants with documented ACTH-dependent Cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria
Who cannot join
- Women who are pregnant or lactating
- History of bilateral adrenalectomy
- Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm
- Presence of any known malignancy
- Use of mitotane
- Previous unsuccessful surgery for Cushing's syndrome within 6 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, 20892
About this study
Official title: A Phase 1b/2a Open-label Multiple-ascending Dose Exploratory Study of CRN04894 in ACTH-dependent Cushing's Syndrome (Cushing's Disease or Ectopic ACTH Syndrome)
A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone [ACTH] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome [EAS])
Read the detailed description
This is a Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with atumelnant (also known as CRN04894) (an adrenocorticotropic hormone [ACTH] receptor antagonist) over a 10-day or 14-day treatment period in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome [EAS]). Participants will receive oral atumelnant once daily for 10 days followed by monitoring during 4 'wash-out' days, or for 14 days.
- Conditions
- Cushing Syndrome, Cushing Disease, Ectopic ACTH Syndrome
- Being tested
- atumelnant
- Keywords
- Cushing Syndrome, Cushing Disease, Ectopic ACTH Syndrome, CRN04894, atumelnant
- Medical subject headings
- Cushing Syndrome, Pituitary ACTH Hypersecretion, ACTH Syndrome, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atumelnantDrug
Atumelnant is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Ascending Doses | Experimental | Sequential, open-label, 10-day or 14-day fixed-dose cohorts. Receives: Drug: atumelnant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with treatment emergent adverse events (TEAEs)
Measured: Up to Day 15
Proportion of participants with adrenal insufficiency
Measured: Up to Day 15
Proportion of participants with safety findings determined by laboratory testing
Measured: Up to Day 15
Assessment of the maximum observed plasma concentration of CRN04894
Measured: Up to Day 15
Assessment of the time to achieve maximum observed plasma concentration of CRN04894
Measured: Up to Day 15
Assessment of the plasma area under the curve of CRN04894
Measured: Up to Day 15
Secondary outcomes (1)
Change from baseline in early morning serum cortisol
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start12 Oct 2023
- Primary completion25 Aug 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT05804669
- Sponsor's protocol ID
- CRN04894-04
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2023
- Last updated
- 14 Oct 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Open-label Multiple-ascending Dose Exploratory Study of CRN04894 in ACTH-dependent Cushing's Syndrome (Cushing's Disease or Ectopic ACTH Syndrome)
- ClinicalTrials.gov ID
- NCT05804669
- Acronym / sponsor ID
- CRN04894-04
- Conditions
- Cushing Syndrome, Cushing Disease, Ectopic ACTH Syndrome
- Keywords
- Cushing Syndrome, Cushing Disease, Ectopic ACTH Syndrome, CRN04894, atumelnant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 7 Apr 2023 (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.
A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone [ACTH] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome [EAS])
Detailed description
This is a Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with atumelnant (also known as CRN04894) (an adrenocorticotropic hormone [ACTH] receptor antagonist) over a 10-day or 14-day treatment period in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome [EAS]). Participants will receive oral atumelnant once daily for 10 days followed by monitoring during 4 'wash-out' days, or for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Ascending Doses | Experimental | Drug: atumelnantSequential, open-label, 10-day or 14-day fixed-dose cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult male or female, aged 18 years or more
- Evidence of chronic 'active' ACTH-dependent Cushing's syndrome
- Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1
- Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to Investigator's judgment. Participants with documented ACTH-dependent Cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria
Key exclusion criteria (6 listed)
- Women who are pregnant or lactating
- History of bilateral adrenalectomy
- Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm
- Presence of any known malignancy
- Use of mitotane
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 |
|---|---|---|
| atumelnantAtumelnant is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets. | Drug | Multiple Ascending Doses |
Primary outcome
Proportion of participants with treatment emergent adverse events (TEAEs)
Time frame: Up to Day 15
Proportion of participants with adrenal insufficiency
Time frame: Up to Day 15
Proportion of participants with safety findings determined by laboratory testing
Time frame: Up to Day 15
Assessment of the maximum observed plasma concentration of CRN04894
Time frame: Up to Day 15
Assessment of the time to achieve maximum observed plasma concentration of CRN04894
Time frame: Up to Day 15
Assessment of the plasma area under the curve of CRN04894
Time frame: Up to Day 15
1 secondary outcome
Change from baseline in early morning serum cortisol
Time frame: Up to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing atumelnant in people with Cushing Syndrome and Cushing Disease, run by Crinetics Pharmaceuticals Inc. at 1 site in United States.
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 4 inclusion and 6 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants with treatment emergent adverse events (TEAEs) (time frame: Up to Day 15). The study lists 6 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 14 Oct 2026.