Clinical trial · Interventional
A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 \[EAS\])
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cushing Disease | — | UNRESOLVED | — |
| Cushing Syndrome | — | UNRESOLVED | — |
| Ectopic ACTH Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| atumelnant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multiple Ascending Doses
- description
- Sequential, open-label, 10-day or 14-day fixed-dose cohorts.
- interventionNames
- Drug: atumelnant
Primary outcomes (6)
- measure
- Proportion of participants with treatment emergent adverse events (TEAEs)
- timeFrame
- Up to Day 15
- measure
- Proportion of participants with adrenal insufficiency
- timeFrame
- Up to Day 15
- measure
- Proportion of participants with safety findings determined by laboratory testing
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult male or female, aged 18 years or more 2. Evidence of chronic 'active' ACTH-dependent Cushing's syndrome 3. Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1 4. 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 Exclusion Criteria: 1. Women who are pregnant or lactating 2. History of bilateral adrenalectomy 3. Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm 4. Presence of any known malignancy 5. Use of mitotane 6. Previous unsuccessful surgery for Cushing's syndrome within 6 weeks
References
Publications (0)
Data not yet available