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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT03697109
• Date of registration: 27/09/2018
• Prospective Registration: Yes
• Primary sponsor: Corcept Therapeutics
• Public title: A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome GRACE
• Scientific title: Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant
• Date of first enrolment: November 15, 2018
• Target sample size: 152
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03697109
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Austria, Bulgaria, Canada, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain, United States

Contacts

• Name: Andreas Moraitis, MD
• Affiliation: Corcept Therapeutics

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cushing Syndrome

Intervention(s)

Other: Placebo

Drug: Relacorilant

Primary Outcome(s)

In all patients, assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0. [Time Frame: Screening through Post Treatment Follow-up (up to 48 weeks)]

In patients with hypertension, the proportion of patients with a loss of response with respect to hypertension from visit OL22 to RW12 [Time Frame: Week OL22 to Week RW12]

Secondary Outcome(s)

Proportion of patients who worsened, as assessed by the Global Clinical Response, from Week OL22 to Week RW12/ET as compared between relacorilant and placebo [Time Frame: Week OL22 to Week RW12]

In patients with IGT at Baseline, the mean change from Visit OL22 to RW12 in the 2 hour glucose value of the oGTT [Time Frame: Week OL22 to week RW12]

The mean change in body weight, body fat measured with DXA scan and Cushing Quality-of-Life (QoL) score as compared between relacorilant and placebo [Time Frame: Week OL22 to week RW12]

In patients with DM (HbA1c =6.5% at Baseline), the mean change in HbA1c from Baseline to Visit OL22/ET [Time Frame: Baseline to week OL22 or ET]

In patients with DM (HbA1c at Baseline >6.5%), the mean change from Visit OL22 to RW12 in HbA1c as compared between relacorilant and placebo. [Time Frame: Open Label week 22 (OL22) to Randomized Withdraw week 12 (RW12)]

For patients in either subgroup (DM/IGT or hypertension) the proportion of patients with any increase or modification in diabetes or antihypertensive medication as compared between relacorilant and placebo [Time Frame: Week OL22 to week RW12]

In patients with IGT, the mean change in 2-hour oGTT glucose from Baseline to Visit OL22/ET [Time Frame: Baseline to week OL22 or ET]

In patients with diabetes mellitus/impaired glucose tolerance (DM/IGT), the mean change in area under the curve for glucose from Week OL22 to Week RW12 as compared between relacorilant and placebo [Time Frame: Week Open label 22 (OL22) to Week Randomized withdraw 12 (RW12)]

In patients with hypertension the mean change in SBP or DBP as compared between relacorilant and placebo [Time Frame: Week OL22 to week RW12]

In patients with uncontrolled hypertension the mean change in SBP or DBP from Baseline to visit OL22/ET [Time Frame: Baseline to week OL22 or ET]

Mean change in QoL, body fat composition as determined by DXA, Beck Depression inventory-II (BDI-II) and body weight from Baseline to visit OL22 or end of treatment (ET) [Time Frame: Baseline to week OL22 or End of Treatment (ET)]

Secondary ID(s)

CORT125134-455

Source(s) of Monetary Support

Please refer to primary and secondary sponsors