A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome
Recruiting now · Phase 1/Phase 2
Conditions studied: Cushing Syndrome, Cushing Disease, Ectopic ACTH Syndrome
In brief
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 \[EAS\])
Key facts
- Study ID
- NCT05804669
- Run by
- Crinetics Pharmaceuticals Inc.
- People needed
- 18
- Starts
- 2023-10-12
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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