RecruitingPhase 1Phase 2NCT05804669

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

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)


Sponsor

Crinetics Pharmaceuticals Inc.

Enrollment

18 participants

Start Date

Oct 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called CRN04894 for people with Cushing's syndrome — a condition where the body produces too much cortisol (a stress hormone), caused by a tumor that overproduces ACTH, a hormone that signals the adrenal glands to make cortisol. **You may be eligible if:** - You are 18 or older (any gender) - You have been diagnosed with ACTH-dependent Cushing's syndrome (meaning your cortisol is too high because of a tumor producing excess ACTH) - Your Cushing's syndrome is currently active - You may be taking certain medications to lower cortisol (ketoconazole, osilodrostat, metyrapone, or cabergoline) but would need to stop them for a washout period before joining **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have had both adrenal glands removed - You have a known cancer - You have a pituitary tumor very close to the optic nerve - You have recently taken the drug mitotane - You had unsuccessful Cushing's surgery within the past 6 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGatumelnant

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


Locations(1)

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

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05804669


Related Trials