A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement

Description

The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach). The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.

Conditions

Endogenous Cushing Syndrome, Adrenal Insufficiency, Hypercortisolism

Study Overview

Study Details

Study overview

The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach). The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.

A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement

A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement

Condition
Endogenous Cushing Syndrome
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Endogenous Cushing syndrome, either following surgery or not candidates for surgery
  • * Under consideration to receive osilodrostat as part of their clinical care
  • * Able to provide informed consent.
  • * Treatment with other investigational drugs within 30 days or five half-lives (whichever is longer).
  • * A history of hypersensitivity to osilodrostat or therapies of a similar chemical class.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Richard Auchus, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2027-08