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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 and/or uncontrolled hypertension

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics

Criteria

Inclusion Criteria:

• Has a confirmed diagnosis of endogenous Cushing syndrome

• Meets at least one of the following criteria:

• Has Type 2 diabetes mellitus

• Has impaired glucose tolerance

• Has hypertension

Exclusion Criteria:

• Has non-endogenous source of hypercortisolemia

• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

• Has poorly controlled hypertension

• Has poorly controlled diabetes mellitus

• Has severe renal insufficiency