Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in GRADIENT, a Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with Cushing's syndrome (hypercortisolism) caused by an adrenal adenoma or adrenal hyperplasia.
"Hypercortisolism with adrenal etiology affects many patients and is associated with serious cardiometabolic comorbidities, including hypertension and hyperglycemia, and increased risk of premature death," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "GRADIENT is the first prospective placebo-controlled study to be conducted exclusively in these patients with Cushing's syndrome. We expect data from GRADIENT in the fourth quarter of this year."
GRADIENT is a randomized, double-blind, placebo-controlled trial conducted at sites in the United States, Europe and Israel. One-hundred thirty-seven patients were randomized 1:1 to receive relacorilant or placebo for 22 weeks. Primary endpoints are improvement in glucose metabolism and hypertension.
Corcept Therapeutics Incorporated(納斯達克股票代碼:CORT)是一家處於商業階段的公司,致力於發現和開發通過調節激素皮質醇的作用來治療嚴重的內分泌、腫瘤、代謝和神經系統疾病的藥物。該公司今天宣佈完成GRADIENT的註冊,這是一項針對庫欣綜合徵(高皮質醇增多症)患者的專有選擇性皮質醇調節劑racorilant的三期試驗由腎上腺腺瘤或腎上腺增生引起。
Corcept首席開發官PharmD比爾·蓋爾說:“腎上腺病因的高皮質醇中毒會影響許多患者,並與嚴重的心臟代謝合併症有關,包括高血壓和高血糖,以及過早死亡的風險增加。”“GRADIENT是第一項專門針對這些庫欣綜合徵患者進行的前瞻性安慰劑對照研究。我們預計GRADIENT的數據將在今年第四季度發佈。”
GRADIENT 是一項隨機、雙盲、安慰劑對照試驗,在美國、歐洲和以色列的研究中心進行。一百三十七名患者按照 1:1 的隨機分配,接受爲期 22 周的 relacorilant 或安慰劑。主要終點是改善葡萄糖代謝和高血壓。