NCT06712823

An Extension Study to Evaluate Safety and Efficacy in Participants Treated With CRN04894

An Open-label, Long-term Extension Study to Evaluate Safety and Efficacy in Participants Treated With CRN04894

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Crinetics Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).

Detailed description

This single-arm, long-term, open-label, study is designed to evaluate the safety, tolerability, and efficacy of atumelnant (CRN04894) in participants with congenital adrenal hyperplasia (CAH). Enrollment will be limited to individuals who completed a parent study with CRN04894 or completed treatment in a Crinetics atumelnant study, and in the opinion of the Investigator had an acceptable benefit-risk assessment in the completed study and would benefit from continued dosing in this extension study. Approximately 150 participants will be enrolled in the study.

Conditions

• Congenital Adrenal Hyperplasia
• Classic Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	atumelnant (CRN04894)	Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist.

Timeline

• Start date: 2025-02-25
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2024-12-02
• Last updated: 2025-09-23

Locations

9 sites across 6 countries: United States, Argentina, Brazil, Germany, Italy, United Kingdom

Regulatory

• FDA-regulated drug study