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

NCT05804669 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CRN04894-04
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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 \[EAS\])

Conditions

Cushing Syndrome; Cushing Disease; Ectopic ACTH Syndrome

Keywords

Cushing Syndrome; Cushing Disease; Ectopic ACTH Syndrome; CRN04894; atumelnant

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (1)

• Change from baseline in early morning serum cortisol

  Up to Day 15

Study Arms (1)

Multiple Ascending Doses

EXPERIMENTAL

Sequential, open-label, 10-day or 14-day fixed-dose cohorts.

Drug: atumelnant

Interventions

atumelnant DRUG

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

Multiple Ascending Doses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (1)

National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Bethesda, Maryland, 20892, United States

RECRUITING

MeSH Terms

Conditions

Cushing Syndrome; Pituitary ACTH Hypersecretion; ACTH Syndrome, Ectopic

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms

Central Study Contacts

Crinetics Clinical Trials

CONTACT

833-827-9741; clinicaltrials@crinetics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: October 12, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)