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

This Phase 3 study involves two phases, an open-label (OL) phase and a randomized-withdrawal
(RW) phase. Patients will dose-escalate in 100 mg increments to a target dose of 400 mg
orally once daily during the open-label phase. Patients will remain on open-label treatment
until week 22 at which time they will be evaluated for the randomized-withdrawal phase based
on pre-defined hyperglycemia and hypertension response criteria. Eligible patients will then
be randomized to receive either relacorilant or placebo at a 1:1 ratio for 12 weeks. Patients
who do not meet the criteria for randomization will end treatment and may be eligible to roll
over into an extension safety study. Patients who complete the randomized-withdrawal phase of
the study may also be eligible to roll over into an extension study.

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