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

Last updated: November 15, 2024
Sponsor: Corcept Therapeutics
Overall Status: Completed

Phase

3

Condition

Cushing's Disease

Female Hormonal Deficiencies/abnormalities

Treatment

relacorilant

Placebo

Clinical Study ID

NCT04308590
CORT125134-456
  • Ages 18-80
  • All Genders

Study 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 and/or uncontrolled systolic hypertension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Shows lack of cortisol suppression

  • Suppressed or low early-morning ACTH levels

  • A radiologically confirmed adrenal lesion

  • Has IGT or DM

  • Has uncontrolled hypertension

Exclusion

Exclusion Criteria:

  • Has severe, uncontrolled hypertension

  • Has poorly controlled DM

  • Has DM Type 1

  • Has significantly abnormal liver test results or severe renal insufficiency

  • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Study Design

Total Participants: 137
Treatment Group(s): 2
Primary Treatment: relacorilant
Phase: 3
Study Start date:
July 27, 2020
Estimated Completion Date:
October 08, 2024

Study Description

This Phase 3 study 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.

Connect with a study center

  • Site 49

    Graz, Styria 8036
    Austria

    Site Not Available

  • Site 25

    Wien, Vienna 1090
    Austria

    Site Not Available

  • Site 22

    Sofia, 01431
    Bulgaria

    Site Not Available

  • Site 50

    Munich, Bavaria 80336
    Germany

    Site Not Available

  • Site 46

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Site 24

    Kfar-Saba, 44281
    Israel

    Site Not Available

  • Site 18

    Petach Tikva, 4941480
    Israel

    Site Not Available

  • Site 32

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Site 23

    Tel Aviv,
    Israel

    Site Not Available

  • Site 40

    Milan, Milano 20122
    Italy

    Site Not Available

  • Site 31

    Rome, Roma 00189
    Italy

    Site Not Available

  • Site 43

    Orbassano, Torino
    Italy

    Site Not Available

  • Site 34

    Milan,
    Italy

    Site Not Available

  • Site 28

    Napoli, 80131
    Italy

    Site Not Available

  • Site 51

    Padova, 35128
    Italy

    Site Not Available

  • Site 37

    Rome, 00161
    Italy

    Site Not Available

  • Site 52

    Torino, 10126
    Italy

    Site Not Available

  • Site 48

    Gliwice, 44-102
    Poland

    Site Not Available

  • Site 47

    Krakow, 31-501
    Poland

    Site Not Available

  • Site 35

    Lublin,
    Poland

    Site Not Available

  • Site 38

    Bucharest, 011863
    Romania

    Site Not Available

  • Site 41

    Bucharest, 011863
    Romania

    Site Not Available

  • Site 42

    Bucharest, 010825
    Romania

    Site Not Available

  • Site 29

    Girona, 17007
    Spain

    Site Not Available

  • Site 14

    Malaga, 29006
    Spain

    Site Not Available

  • Site 13

    Sevilla, 41013
    Spain

    Site Not Available

  • Site 26

    Valencia, 46026
    Spain

    Site Not Available

  • Site 27

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Site 17

    Stanford, California 94305
    United States

    Site Not Available

  • Site 53

    Torrance, California 90502
    United States

    Site Not Available

  • Site 55

    Miami, Florida 33136
    United States

    Site Not Available

  • Site 07

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Site 16

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Site 09

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Site 36

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Site 11

    Fall River, Massachusetts 02721
    United States

    Site Not Available

  • Site 45

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Site 33

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Site 06

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Site 54

    Reno, Nevada 89511
    United States

    Site Not Available

  • Site 19

    Albany, New York 12206
    United States

    Site Not Available

  • Site 10

    Jamaica, New York 11432
    United States

    Site Not Available

  • Site 44

    New York, New York 10021
    United States

    Site Not Available

  • Site 01

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Site 30

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Site 21

    Columbus, Ohio 43201-3209
    United States

    Site Not Available

  • Site 39

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Site 12

    Pittsburgh, Pennsylvania 15202
    United States

    Site Not Available

  • Site 02

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • Site 07

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • Site 20

    Dallas, Texas 75390
    United States

    Site Not Available

  • Site 03

    El Paso, Texas 79935
    United States

    Site Not Available

  • Site 05

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • Site 08

    Houston, Texas 77079
    United States

    Site Not Available

  • Site 04

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Site 15

    Spokane, Washington 99202
    United States

    Site Not Available

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