Extension Study of Atumelnant for Congenital Adrenal Hyperplasia
This study is an extension to evaluate the long-term safety and effectiveness of atumelnant (CRN04894) for individuals with Congenital Adrenal Hyperplasia (CAH). Atumelnant works by blocking the melanocortin 2 receptor (MC2R), which is involved in how your body responds to stress hormones. You can join this study if you are between 16 and 74 years old, have CAH, and have already completed a previous Crinetics atumelnant CAH study. The main goals are to track any side effects, including serious ones like adrenal insufficiency, and to see if the medication helps reduce hospitalizations related to CAH over 108 weeks. The study aims to enroll about 200 participants.
- Study design
- This is a single-arm, open-label study, meaning all participants will receive atumelnant and everyone involved will know what treatment is being given. It plans to enroll approximately 150 to 200 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 108 weeks to monitor for side effects and other health events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia
At a glance
Conditions
NCT06712823
Where you'd take part
This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Crinetics Study Site
Córdoba, Córdoba Province, Argentinano site contact published
Recruiting
Crinetics Study Site
Curitiba, Paraná, Brazilno site contact published
Recruiting
Crinetics Study Site
Porto Alegre, Rio Grande do Sul, Brazilno site contact published
Recruiting
Crinetics Study Site
Botucatu, São Paulo, Brazilno site contact published
Recruiting
Crinetics Study Site
Rio de Janeiro, Brazilno site contact published
Recruiting
Crinetics Study Site
São Paulo, Brazilno site contact published
Recruiting
Crinetics Study Site
Munich, Bavaria, Germanyno site contact published
Recruiting
Crinetics Study Site
Roma, Italyno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (SAEs), adverse events of special interest (AESI [adrenal insufficiency]) and any adverse events (AEs) leading to discontinuationWeek 108
- Incidence of glucocorticoid (GC) deficiency / adrenal insufficiency and adrenal crisisWeek 108
- Incidence of hospitalizations related to congenital adrenal hyperplasia (CAH)Week 108
- Change from baseline in morning (before 11:00 AM) serum androstenedione (A4) over timeWeek 108