NCT04308590

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

Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia (GRADIENT): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Hypercortisolism

Interventions

Type	Name	Description
DRUG	Relacorilant	Relacorilant is supplied as blister-packed capsules for oral dosing. Relacorilant 400 mg dose consists of 4 relacorilant 100-mg capsules. Relacorilant 100-mg, 200-mg, and 300-mg doses are each given as a combination of 4 capsules containing relacorilant 100-mg and placebo as per the assigned dose.
OTHER	Placebo	Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo.

Timeline

• Start date: 2020-07-27
• Primary completion: 2024-09-19
• Completion: 2024-09-19
• First posted: 2020-03-16
• Last updated: 2025-09-04
• Results posted: 2025-08-03

Locations

45 sites across 9 countries: United States, Austria, Bulgaria, Germany, Israel, Italy, Poland, Romania, Spain

Regulatory

• FDA-regulated drug study