NCT07144163

A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants With Classic Congenital Adrenal Hyperplasia (Calm-CAH)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Crinetics Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.

Detailed description

This is a Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study in adult participants (male or female age ≥18 to \<75 years) with classic CAH due to 21-OHD who have been on a stable regimen of GCs for at least 2 months to evaluate efficacy, safety, PK, and PD of atumelnant administered once per day. Following a 3- to 6-week Screening Period, eligible participants will enter the Treatment Period where they will be randomly assigned in a 2:1 ratio to receive either atumelnant 80 mg once daily (with an option for dose escalation to 120 mg once daily at Week 20) or placebo. A total of approximately 150 participants may be enrolled in the study.

Conditions

• Congenital Adrenal Hyperplasia
• Classic Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Atumelnant	Atumelnant, tablets, once daily by mouth
DRUG	Placebo	Placebo, tablets, once daily by mouth

Timeline

• Start date: 2025-12-11
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-08-27
• Last updated: 2026-03-24

Locations

17 sites across 7 countries: United States, Argentina, Australia, Brazil, France, Germany, Poland

Regulatory

• FDA-regulated drug study