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

Description

A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone \[ACTH\] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \[EAS\])

Conditions

Cushing Syndrome, Cushing Disease, Ectopic ACTH Syndrome

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Study Overview

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Study Details

Study overview

A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone \[ACTH\] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \[EAS\])

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)

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

Condition
Cushing Syndrome
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Bethesda, Maryland, United States, 20892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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, cabergoline or metyrapone) may participate after a 14-day washout period, if they meet other study inclusion 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Crinetics Pharmaceuticals Inc.,

Study Record Dates

2026-10