Clinical trial

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

Name

CORT125134-455

Description

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

Trial arms

Trial start

2018-11-15

Estimated PCD

2024-04-08

Trial end

2024-04-15

Status

Completed

Phase

Early phase I

Treatment

Relacorilant

Relacorilant is supplied as 100 mg capsules for oral dosing.

Arms:

Relacorilant (open-label phase), Relacorilant (randomized-withdrawal phase)

Other names:

CORT125134

Placebo

Placebo matched to study drug

Arms:

Placebo (randomized-withdrawal phase)

Size

152

Primary endpoint

In patients with hypertension, the proportion of patients with a loss of response with respect to hypertension from visit OL22 to RW12

Week OL22 to Week RW12

In all patients, assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0.

Screening through Post Treatment Follow-up (up to 48 weeks)

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 152, 'type': 'ACTUAL'}}

Updated at

2024-06-10

1 organization

1 product

1 indication

Organization

Corcept Therapeutics

Product

Relacorilant

Indication

Cushing's syndrome