Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05804669

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

Led by Crinetics Pharmaceuticals Inc. · Updated on 2025-04-10

18

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult male or female, aged 18 years or more
  • Evidence of chronic 'active' ACTH-dependent Cushing's syndrome
  • Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1
  • Participants taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after at least 5 days washout, if eligible
  • Participants taking cabergoline may participate after at least 14 days washout, if eligible
Not Eligible

You will not qualify if you...

  • Women who are pregnant or lactating
  • History of bilateral adrenalectomy
  • Previous pituitary MRI showing ACTH-secreting lesion within 3 mm of optic chiasm
  • Presence of any known malignancy
  • Use of mitotane
  • Previous unsuccessful surgery for Cushing's syndrome within 6 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

C

Crinetics Clinical Trials

CONTACT

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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