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 - GRADIENT

Corcept Therapeutics Incorporated0 sites130 target enrollmentJuly 10, 2020

Overview

No summary available.

Registry

who.int

Start Date

July 10, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•To enroll in this study, each patient must meet the following key inclusion criteria:
•1\. Male or female, 18 to 80 years of age, inclusive.
•2\. Lack of cortisol suppression (\>1\.8 µg/dL serum cortisol with adequate dexamethasone levels) on either 1\-mg overnight or 2\-mg 48\-hour DST during Screening.
•3\. Suppressed or low (\=15 pg/mL) early\-morning ACTH levels on at least 2 occasions during Screening.
•4\. A radiologically confirmed benign adrenal lesion (single adenoma, multiple adenomas, hyperplasia \[\=3 times the size of the normal adrenal gland]) within 3 years prior to Screening.
•5\. Has at least 1 of the following at Baseline:
•DM (fasting plasma glucose \=126 mg/dL and/or 2\-hour oGTT plasma glucose \=200 mg/dL at 2 hours, or HbA1c \=6\.5%), or IGT (plasma glucose \=140 mg/dL and \<200 mg/dL on a 2\-hour oGTT).
•Systolic hypertension (average SBP \=130 to \=170 mm Hg) based on 24\-hour ABPM.
•6\. If receiving medical treatment for DM/IGT or hypertension, there has been no increase in medication dosage for at least 4 weeks prior to Baseline assessment.
•7\. For women of childbearing potential, has a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline.

•Patients who meet any of the following criteria will not be permitted entry to the study:
•1\. Has severe, uncontrolled hypertension (average SBP \>170 mm Hg or average DBP \>110 mm Hg at Screening), based on 24\-hour ABPM.
•2\. Has poorly controlled DM (HbA1c \>12% at Screening).
•3\. Has DM Type 1
•4\. Has abnormal liver test results (total bilirubin \>1\.5×ULN or elevated alanine aminotransferase or aspartate aminotransferase \>3×ULN at Baseline).
•5\. Has severe renal insufficiency (glomerular filtration rate \=29 mL/min/1\.73 m2 at Baseline).
•6\. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
•7\. Has prolonged QT interval corrected for heart rate using Fridericia’s equation (QTcF) (\>450 ms for men and \>470 ms for women) with normal QRS interval (\<120 ms) or QTcF interval \>500 ms with wide QRS interval (\=120 ms).
•8\. Has persistent atrial fibrillation.
•9\. Has used or plans to use any treatments for Cushing syndrome within 12 weeks prior to Screening and throughout the study, including mifepristone, metyrapone, osilodrostat, ketoconazole, fluconazole, or any investigational drug for treatment of Cushing syndrome