Enrollment complete in relacorilant Phase 3 GRADIENT trial
Trial to assess safety, effect on blood pressure and sugar
A Phase 3 trial testing the oral medication relacorilant in people with Cushing’s syndrome caused by adrenal adenoma, a type of adrenal gland tumor, or adrenal hyperplasia, a condition in which the adrenal glands become enlarged, has finished enrolling participants.
Relacorilant’s developer, Corcept Therapeutics, said 137 participants have been enrolled in the GRADIENT trial at sites across the U.S., Europe, and Israel. Data are expected in the fourth quarter.
“GRADIENT is the first prospective placebo-controlled study to be conducted exclusively in these patients with Cushing’s syndrome,” Bill Guyer, chief development officer of Corcept, said in a company press release.
Cushing’s syndrome is an umbrella term encompassing disorders with symptoms driven by hypercortisolism, or excess levels of the stress hormone cortisol. Cushing’s disease is a specific form of the syndrome in which hypercortisolism is caused by a tumor in the brain’s pituitary gland.
Relacorilant targets cortisol receptors
Tumors in the adrenal glands, which are responsible for producing cortisol and other hormones, also can cause Cushing’s. Guyer noted that Cushing’s associated with adrenal tumors or other adrenal abnormalities “affects many patients and is associated with serious cardiometabolic comorbidities, including hypertension [high blood pressure] and hyperglycemia [high blood sugar levels], and increased risk of premature death.”
Relacorilant is designed to treat all forms of endogenous Cushing’s syndrome, or those that are caused by problems within the body itself. Those problems are most often tumors. The therapy works by blocking cortisol receptors called glucocorticoid receptors, reducing the abnormal cortisol signaling that drives Cushing’s symptoms.
In the Phase 3 GRADIENT trial (NCT04308590), participants are randomly assigned to receive the experimental oral therapy or a placebo for 22 weeks, or about five months. Relacorilant will be started at a dose of 100 mg per day and gradually increased to a target dose of 400 mg per day, based on tolerability.
The study’s main goals are to assess relacorilant’s safety and its effect on blood pressure and blood sugar levels, both of which are frequently elevated in Cushing’s patients.
Corcept is conducting another Phase 3 clinical trial, GRACE (NCT03697109), which is testing relacorilant in people with endogenous Cushing’s syndrome who have co-occurring type 2 diabetes, glucose intolerance, and/or high blood pressure. That study finished enrolling participants last year, and results are expected in the coming months. Corcept has announced plans to seek approval of relacorilant in the U.S. if results from GRACE are positive.
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