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

Corcept Therapeutics

Status and phase: Completed; Phase 3

Conditions: Cushing Syndrome

Treatments: Other: Placebo; Drug: Relacorilant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03697109

CORT125134-455

Details and patient eligibility

About

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).

Full description

The primary outcome is the assessment of efficacy of relacorilant treatment based on sustained blood pressure control during the Randomized-withdrawal (RW) Phase, wherein patients who had achieved the blood pressure response criteria during the Open-label (OL) Phase are randomized to receive either relacorilant or placebo for 12 weeks.

Patients in the OL Phase will dose-escalate in 100 mg increments to a maximum dose of 400 mg orally once daily. Patients will remain on OL treatment until Week 22 at which time they will be evaluated for the RW Phase based on predefined 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 the RW Phase will end treatment and may be eligible to roll over into an extension safety study. Patients who complete the RW Phase of the study may also be eligible to roll over into an extension study.

Enrollment: 152 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a confirmed diagnosis of endogenous Cushing syndrome

• Meets at least 1 of the following criteria:

  • Has Type 2 diabetes mellitus
  • Has impaired glucose tolerance
  • Has hypertension.

Exclusion criteria

• Has non-endogenous source of hypercortisolism
• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
• Has poorly controlled hypertension
• Has poorly controlled diabetes mellitus
• Has severe renal insufficiency.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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152 participants in 3 patient groups, including a placebo group

Relacorilant (OL Phase)

Experimental group

Description:

Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.

Treatment:

Drug: Relacorilant

Relacorilant (RW Phase)

Experimental group

Description:

Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase.

Treatment:

Drug: Relacorilant

Placebo (RW Phase)

Placebo Comparator group

Description:

Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug.

Treatment:

Other: Placebo