A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509171-16-00

Acronym

NBI-74788-CAH3003

Enrollment

Registered

2024-07-11

Start date

2020-11-23

Completion date

Unknown

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Classic Congenital Adrenal Hyperplasia (CAH)

Brief summary

Percent change from baseline in glucocorticoid daily dose (in hydrocortisone equivalents adjusted for BSA [mg/m2/day]) at Week 24.

Detailed description

Change from baseline in serum androstenedione at Week 4., Achievement of a reduction in glucocorticoid daily dose to physiologic levels Week 24., Changes from baseline in HOMA-IR, weight, and fat mass at Week 24

Interventions

DRUGNBI-74788

DRUGCrinecerfont placebo for oral capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in glucocorticoid daily dose (in hydrocortisone equivalents adjusted for BSA [mg/m2/day]) at Week 24.	—

Secondary

Measure	Time frame
Change from baseline in serum androstenedione at Week 4., Achievement of a reduction in glucocorticoid daily dose to physiologic levels Week 24., Changes from baseline in HOMA-IR, weight, and fat mass at Week 24	—

Countries

Austria, Belgium, Bulgaria, Czechia, France, Germany, Greece, Italy, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026