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 and/or uncontrolled systolic hypertension.

Full description

This Phase 3 study 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
• Suppressed or low early-morning ACTH levels
• A radiologically confirmed adrenal lesion
• Has IGT or DM
• Has uncontrolled hypertension

Exclusion criteria

• Has severe, uncontrolled hypertension
• 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:

The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily.

Treatment:

Drug: relacorilant

Placebo

Placebo Comparator group

Description:

Placebo matched to study drug

Treatment:

Other: Placebo