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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Crinetics Pharmaceuticals Inc.
Study ID
NCT05804669
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cushing Disease
  • Cushing Syndrome
  • Ectopic ACTH Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 \[EAS\])

Key Dates

Start date
Oct 12, 2023
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Multiple Ascending Doses
    Sequential, open-label, 10-day or 14-day fixed-dose cohorts.

Primary Outcome Measure

Proportion of participants with treatment emergent adverse events (TEAEs) [ Time Frame: Up to Day 15 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)BethesdaMaryland20892
Lynnette K Nieman, MD
[email protected]
301-496-8935
Lynnette K Nieman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bethesda, MD

By research site
National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)· Bethesda, MD

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