A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome

Launched by CRINETICS PHARMACEUTICALS INC. · Mar 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called CRN04894 to see how safe it is and how well it works for treating Cushing's syndrome, a condition where the body makes too much of a hormone called cortisol. Participants in this trial will be adults aged 18 and older who have been diagnosed with ACTH-dependent Cushing's syndrome, which is a specific type of this condition. To participate, they should show signs of the syndrome and should not have undergone certain surgeries or have other health issues that might complicate the study.

If someone joins the trial, they can expect to receive multiple doses of CRN04894 and will be closely monitored for how their body responds to the treatment. This study is currently looking for volunteers, and it’s open to both men and women. It is important to note that pregnant or breastfeeding women cannot participate, and those with certain medical histories, like previous surgeries for Cushing's syndrome or specific types of cancer, are also excluded. Overall, this trial aims to gather important information that could help improve treatment options for people with Cushing's syndrome in the future.

Gender

ALL

Eligibility 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