Evaluating CRN04894 for treating Cushing's Syndrome
A Phase 1b/2a Open-label Multiple-ascending Dose Exploratory Study of CRN04894 in ACTH-dependent Cushing's Syndrome (Cushing's Disease or Ectopic ACTH Syndrome)
This study is testing a new medication called CRN04894 to see if it can safely help adults with Cushing's syndrome feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Crinetics Pharmaceuticals Inc. Industry-sponsored |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05804669 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1b/2a, first-in-disease, open-label study designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic responses of CRN04894, an ACTH receptor antagonist, in adults with ACTH-dependent Cushing's syndrome. Participants will receive oral doses of the medication once daily for either 10 or 14 days, followed by a monitoring period. The study aims to gather data on how well the drug works and its effects on the body over the treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic active ACTH-dependent Cushing's syndrome.
Not a fit: Patients who are pregnant, lactating, or have a history of certain adrenal surgeries or malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Cushing's syndrome.
How similar studies have performed: While this approach is novel in its specific application, similar studies targeting ACTH-dependent conditions have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult male or female, aged 18 years or more 2. Evidence of chronic 'active' ACTH-dependent Cushing's syndrome 3. Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1 4. Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to Investigator's judgment. Participants with documented ACTH-dependent Cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria Exclusion Criteria: 1. Women who are pregnant or lactating 2. History of bilateral adrenalectomy 3. Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm 4. Presence of any known malignancy 5. Use of mitotane 6. Previous unsuccessful surgery for Cushing's syndrome within 6 weeks
Where this trial is running
Bethesda, Maryland
- National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Crinetics Clinical Trials
- Email: clinicaltrials@crinetics.com
- Phone: 833-827-9741
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.