A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas (GRADIENT)

Corcept Therapeutics

Status and phase: Completed; Phase 3

Conditions: Hypercortisolism

Treatments: Drug: Relacorilant; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04308590

CORT125134-456

Details and patient eligibility

About

This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with diabetes mellitus/ impaired glucose tolerance (DM/IGT) and/or uncontrolled systolic hypertension (HTN).

Full description

The primary outcome measures of the study are 1) to assess the efficacy of relacorilant based on blood pressure control at Week 22 compared with placebo, and 2) to assess the safety of relacorilant based on adverse events. Patients will be randomized in a 1:1 ratio to treatment with relacorilant (active drug) or placebo. Patients will receive relacorilant or placebo for 22 weeks. Patients who complete the study may also be eligible to roll over into an extension study.

Enrollment: 137 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Shows lack of cortisol suppression on dexamethasone suppression test
• Suppressed or low early-morning adrenocorticotropic hormone (ACTH) levels
• A radiologically confirmed adrenal lesion
• Has IGT or DM
• Has uncontrolled HTN

Exclusion criteria

• Has severe, uncontrolled HTN
• Has poorly controlled DM
• Has DM Type 1
• Has significantly abnormal liver test results or severe renal insufficiency
• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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137 participants in 2 patient groups, including a placebo group

Relacorilant

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: Relacorilant

Placebo

Placebo Comparator group

Description:

Patients will receive placebo matched to study drug once daily.

Treatment:

Other: Placebo