Actively Recruiting
A Phase 1b/2a Open-label Multiple-ascending Dose Study of CRN04894 for ACTH-dependent Cushing's Syndrome (Cushing's Disease or Ectopic ACTH Syndrome)
Led by Crinetics Pharmaceuticals Inc. · Updated on 2026-06-04
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CRN04894, an adrenocorticotropic hormone (ACTH) receptor antagonist, in adults with ACTH-dependent Cushing's syndrome, including Cushing's disease and Ectopic ACTH Syndrome (EAS). This Phase 1b/2a open-label study aims to explore the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses of CRN04894 in this patient population. The study is a first-in-disease, multiple-ascending dose exploratory trial to better understand how the drug behaves and affects the condition. Participants will receive oral doses of atumelnant (CRN04894) once daily for either 10 or 14 days in a sequential, open-label format. The treatment periods are followed by a 4-day washout phase after the 10-day dosing group. The study includes fixed-dose cohorts and monitors participants throughout these periods to assess the drug's impact on the disease and the body. During the study, participants will undergo monitoring for safety, including treatment-emergent adverse events, adrenal insufficiency, and laboratory test findings, all assessed up to Day 15. Pharmacokinetic measures include maximum plasma concentration, time to reach this concentration, and plasma exposure over time. Additionally, early morning serum cortisol levels will be tracked to evaluate changes from baseline. The total participation involves dosing and follow-up assessments to collect this comprehensive data.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female aged 18 years or older
- Evidence of chronic active ACTH-dependent Cushing's syndrome
- Evidence of acutely active ACTH-dependent Cushing's syndrome within 10 days before Day 1
- Participants on short-acting steroidogenesis inhibitors may join after at least 5 days washout if eligible
- Participants on cabergoline may join after at least 14 days washout if eligible
You will not qualify if you...
- Women who are pregnant or lactating
- History of bilateral adrenalectomy
- Pituitary MRI showing ACTH-secreting lesion within 3 mm of the optic chiasm
- Presence of any known malignancy
- Use of mitotane
- Unsuccessful surgery for Cushing's syndrome within the past 6 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 to 14 days
Participants receive oral atumelnant once daily for either 10 days followed by 4 wash-out days, or for 14 days to evaluate safety, tolerability, and pharmacokinetics.
Daily visits or assessments during treatment period
Duration - Up to 4 days following treatment
Participants are monitored after treatment for safety and pharmacodynamic biomarker responses.
Visits during wash-out period
Trial Site Locations
Total: 1 location
1
National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
C
Crinetics Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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