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

NCT05804669 · tracked via the Priya Life Science USA tracker

Sponsor

Crinetics Pharmaceuticals Inc.

Phase

Phase 1/2

Started

2023-10-12

Last updated

2026-08-19

Condition(s) studied

Cushing SyndromeCushing DiseaseEctopic ACTH Syndrome

Investigational drug(s) / intervention(s)

atumelnant

atumelnant: Atumelnant is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets.

Study summary

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 \[EAS\])

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Proportion of participants with treatment emergent adverse events (TEAEs) — Up to Day 15
Proportion of participants with adrenal insufficiency — Up to Day 15
Proportion of participants with safety findings determined by laboratory testing — Up to Day 15
Assessment of the maximum observed plasma concentration of CRN04894 — Up to Day 15
Assessment of the time to achieve maximum observed plasma concentration of CRN04894 — Up to Day 15
Assessment of the plasma area under the curve of CRN04894 — Up to Day 15

Trial sites (1)

Facility	City	Region	Status
National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Bethesda	Maryland

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05804669 on ClinicalTrials.gov ↗ ← All trials in the USA