A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome

Summary

This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hypertension (HTN).

Timeline

Start

2018-11-15

Primary completion

2024-04-08

Completion

2024-04-15

Publications

• Pivonello R, Arnaldi G, Auchus RJ, Badiu C, Busch RS, Cannavo S, Dischinger U, Dobri GA, Donegan DM, Elenkova A, Fazeli PK, Feelders RA, Garcia-Centeno R, Gilis-Januszewska A, Hamidi O, Hannoush ZC, Kargi AY, Miller HJ, Ranetti AE, Recasens M, Reincke M, Rovner S, Salvatori R, Silverstein J, Stigliano A, Terzolo M, Wang C, Yuen KCJ, Kesner-Hays A, Hand AL, Tudor IC, Araque KA, Moraitis AG; GRACE Study Investigators. Efficacy and safety of relacorilant for the treatment of patients with Cushing's syndrome (GRACE): a multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study. Lancet Diabetes Endocrinol. 2026 Apr;14(4):291-304. doi: 10.1016/S2213-8587(25)00362-6. Epub 2026 Feb 20.
• Pivonello R, Munster PN, Terzolo M, Ferrigno R, Simeoli C, Puglisi S, Bali U, Moraitis AG. Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant. Front Endocrinol (Lausanne). 2022 Jan 4;12:793262. doi: 10.3389/fendo.2021.793262. eCollection 2021.

Drugs

Indications