A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome

• Status: Recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

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 syndrome (Cushing's disease or Ectopic ACTH Syndrome [EAS])

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Crinetics Pharmaceuticals Inc.

Criteria

Inclusion Criteria:

1. Male or female, aged 18-75 years

2. Vaccination against COVID-19 according to current CDC recommendations

3. Evidence of 'active' ACTH-dependent Cushing's syndrome within 14 days of Day 1

4. Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, cabergoline or metyrapone) may participate after a 14-day washout period, 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 lesion within 3 mm of the optic chiasm

4. Presence of any known malignancy

5. A UFC more than 5-fold ULN

6. Use of mitotane

7. Previous unsuccessful surgery for Cushing's syndrome within 6 weeks