NCT05804669

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Crinetics Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[EAS\])

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

Interventions

Type	Name	Description
DRUG	atumelnant	Atumelnant is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets.

Timeline

• Start date: 2023-10-12
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-04-07
• Last updated: 2025-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study