😷 Clinical Trial: Endogenous Cushing’s Syndrome Patients Sought for Phase 3 Trial Testing Relacorilant

Corcept Therapeutics is recruiting participants for its Phase 3 clinical trial evaluating relacorilant as a potential treatment for Cushing’s syndrome-related side effects such as high blood pressure and impaired glucose tolerance.

Also, findings from the study “A Randomized-Withdrawal, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Selective Glucocorticoid Receptor Antagonist, Relacorilant, in Patients with Cushing Syndrome (GRACE Study),” were presented at the 2019 Annual Meeting of the Endocrine Society (ENDO), in New Orleans, Louisiana.

In endogenous Cushing’s syndrome there is an “internal” culprit — usually a benign tumor — that makes the body produce too much of the hormone cortisol. The excessive amount of circulating cortisol can lead to serious problems, such as type 2 diabetes and high blood pressure.

Relacorilant is designed to prevent the effects of excess cortisol by blocking one of its receptors, the glucocorticoid receptor. Results from a Phase 2 trial (NCT02804750) suggest that relacorilant may manage the effects of prolonged cortisol excess in Cushing’s patients faster and without the known side effects of approved medications like Korlym (mifepristone).

Also, the treatment improved glucose tolerance and improved blood pressure in patients, suggesting it could be used to treat those with endogenous Cushing’s syndrome and concurrent type 2 diabetes mellitus, impaired glucose tolerance, and/or uncontrolled high blood pressure (hypertension).

Corcept has now designed the GRACE Phase 3 trial (NCT03697109), a multicenter, double-blind, placebo-controlled, randomized-withdrawal study, to evaluate relacorilant’s safety and effectiveness in these patients.

GRACE will be conducted in two stages. First, all patients will be given oral relacorilant each day for 22 weeks, at doses rising from 100 mg to a maximum of 400 mg.

Those who complete that stage and show improvements in pre-specified parameters of glucose tolerance or hypertension will move into the second, randomized phase of the trial.

Here, they will be randomly assigned to placebo or relacorilant at the same dose they received at the end of the first stage. This new round of treatment will last 12 weeks. Treatment-related adverse events (side effects) also will be assessed for up to 48 weeks (about 11 months) as a main outcome.

Additional primary goals include changes in glucose tolerance and blood pressure between the end of the first and second stages of the study.

Secondary objectives include identifying the proportion of patients achieving a response in glucose tolerance and high blood pressure criteria and the proportion of those who worsened at the end of the first stage, and the changes in quality of life throughout the study.

Researchers plan to enroll 130 people in these U.S. cities: Indianapolis, Indiana; Metairie, Louisiana; Jackson, Mississippi; Albany, New York; Jamaica, New York; Wilmington, North Carolina; Miami, Florida; Summerville, South Carolina; El Paso, Texas; Oklahoma City, Oklahoma, and; Aurora, Colorado. More detailed information is available here.

“We look forward to presenting new findings concerning cortisol modulation in patients with hypercortisolism,” Joseph K. Belanoff, MD, Corcept’s CEO,  said in a press release.

💊 Top Doctors Receiving Payments From Corcept, makers of Korlym

 

Top Doctors Receiving Payments From this Company

Totals listed account for all payments from August 2013 to December 2016.

DOCTOR PAYMENTS
PEJMAN COHAN

Endocrinology, Diabetes & Metabolism

BEVERLY HILLS, CA

$116K
RICHARD AUCHUS

Internal Medicine

ANN ARBOR, MI

$50,682
TODD FRIEZE

Endocrinology, Diabetes & Metabolism

BILOXI, MS

$40,012
ALAN COHEN

Endocrinology, Diabetes & Metabolism

MEMPHIS, TN

$38,156
AMIR HAMRAHIAN

Endocrinology, Diabetes & Metabolism

CLEVELAND, OH

$36,287
KIMBERLEY BOURNE

Endocrinology, Diabetes & Metabolism

ORLANDO, FL

$35,485
JAMES FINDLING

Endocrinology, Diabetes & Metabolism

MENOMONEE FALLS, WI

$31,486
TY CARROLL

Endocrinology, Diabetes & Metabolism

MENOMONEE FALLS, WI

$28,499
KEVIN YUEN

Endocrinology, Diabetes & Metabolism

SEATTLE, WA

$27,553
JOHN PARKER

Endocrinology, Diabetes & Metabolism

WILMINGTON, NC

$21,878

Top Teaching Hospitals Receiving Payments From this Company

Totals listed account for all payments from August 2013 to December 2016.

HOSPITAL PAYMENTS
HOSPITAL OF THE UNIV OF PENNA

PHILA, PA

$10,000
UNIVERSITY OF LOUISVILLE HOSPITAL

LOUISVILLE, KY

$5,000
UNIV OF MI HOSPITALS & HLTH CTRS

ANN ARBOR, MI

$5,000
CEDARS-SINAI MEDICAL CENTER

LOS ANGELES, CA

$4,550
UNIV OF MISSOURI HEALTH CARE

COLUMBIA, MO

$3,183
LANGLEY PORTER PSYCHIATRIC HOSPTIAL

SAN FRANCISCO, CA

$3,000
NATIONAL JEWISH HEALTH

DENVER, CO

$2,500
TEMPLE UNIVERSITY HOSPITAL

PHILADELPHIA, PA

$2,000
THE MOUNT SINAI HOSPITAL.

NEW YORK, NY

$2,000
ADVOCATE LUTHERAN GENERAL HOSPITAL

PARK RIDGE, IL

$1,700

 

See if your doctor is making money from this drug here:
https://projects.propublica.org/docdollars/company/corcept-therapeutics