search
Back to results

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

Primary Purpose

Hypercortisolism

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
relacorilant
Placebo
Sponsored by
Corcept Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercortisolism focused on measuring Cushing syndrome, Cushing, Hypercortisolemia, Type 2 Diabetes, Impaired Glucose Intolerance, Hypertension, Adrenocorticotropic hormone, Primary Pigmented Nodular Adrenal Disease, Macronodular adrenal hyperplasia, Adrenal Adenoma, Adrenal Autonomy, Cortisol, Autonomous cortisol secretion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Site 27Recruiting
  • Site 17Recruiting
  • Site 53Recruiting
  • Site 07Recruiting
  • Site 16Recruiting
  • Site 09Recruiting
  • Site 36Recruiting
  • Site 11Recruiting
  • Site 45Recruiting
  • Site 33Recruiting
  • Site 06Recruiting
  • Site 54Recruiting
  • Site 19
  • Site 10Recruiting
  • Site 44Recruiting
  • Site 01Recruiting
  • Site 30Recruiting
  • Site 21Recruiting
  • Site 39Recruiting
  • Site 12
  • Site 02Recruiting
  • Site 20Recruiting
  • Site 03Recruiting
  • Site 05Recruiting
  • Site 08Recruiting
  • Site 04
  • Site 15Recruiting
  • Site 49
  • Site 25Recruiting
  • Site 22Recruiting
  • Site 50Recruiting
  • Site 46Recruiting
  • Site 24Recruiting
  • Site 18Recruiting
  • Site 32Recruiting
  • Site 23Recruiting
  • Site 40Recruiting
  • Site 31Recruiting
  • Site 43Recruiting
  • Site 34Recruiting
  • Site 28Recruiting
  • Site 51Recruiting
  • Site 37Recruiting
  • Site 52Recruiting
  • Site 48Recruiting
  • Site 47Recruiting
  • Site 35Recruiting
  • Site 42Recruiting
  • Site 38Recruiting
  • Site 41Recruiting
  • Site 29Recruiting
  • Site 14Recruiting
  • Site 13Recruiting
  • Site 26Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Relacorilant

Placebo

Arm Description

The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily.

Placebo matched to study drug

Outcomes

Primary Outcome Measures

In patients with diabetes/ impaired glucose tolerance (DM/IGT), the mean change in AUC glucose as compared between relacorilant and placebo arm
In patients with systolic hypertension, the change in mean systolic blood pressure (SBP) based on 24-hour ambulatory blood pressure monitor (ABPM) as compared between relacorilant and placebo arms
Rate of safety based TEAEs
Assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0.

Secondary Outcome Measures

In patients with DM at baseline the mean change in HbA1c and fasting glucose
Proportion of patients with IGT at Baseline who achieved normalization of 2-hour oGTT glucose
Proportion of patients with normalization of the mean SBP

Full Information

First Posted
February 27, 2020
Last Updated
October 10, 2023
Sponsor
Corcept Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT04308590
Brief Title
Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
Acronym
GRADIENT
Official Title
Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercortisolism
Keywords
Cushing syndrome, Cushing, Hypercortisolemia, Type 2 Diabetes, Impaired Glucose Intolerance, Hypertension, Adrenocorticotropic hormone, Primary Pigmented Nodular Adrenal Disease, Macronodular adrenal hyperplasia, Adrenal Adenoma, Adrenal Autonomy, Cortisol, Autonomous cortisol secretion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relacorilant
Arm Type
Experimental
Arm Description
The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matched to study drug
Intervention Type
Drug
Intervention Name(s)
relacorilant
Intervention Description
Relacorilant is supplied as 100 mg capsules for oral dosing.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo is supplied as 100 mg capsules for oral dosing.
Primary Outcome Measure Information:
Title
In patients with diabetes/ impaired glucose tolerance (DM/IGT), the mean change in AUC glucose as compared between relacorilant and placebo arm
Time Frame
Baseline to week 22
Title
In patients with systolic hypertension, the change in mean systolic blood pressure (SBP) based on 24-hour ambulatory blood pressure monitor (ABPM) as compared between relacorilant and placebo arms
Time Frame
Baseline to week 22
Title
Rate of safety based TEAEs
Description
Assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0.
Time Frame
Baseline to week 22
Secondary Outcome Measure Information:
Title
In patients with DM at baseline the mean change in HbA1c and fasting glucose
Time Frame
Baseline to week 22/ET
Title
Proportion of patients with IGT at Baseline who achieved normalization of 2-hour oGTT glucose
Time Frame
Week 22/ET
Title
Proportion of patients with normalization of the mean SBP
Time Frame
Baseline to week 22/ET

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Lead
Phone
650 327 3270
Email
GRADIENTstudy@corcept.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Moraitis, MD
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Site 27
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 17
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 53
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 07
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 16
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 09
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 36
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 11
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 45
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 33
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 06
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 54
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 19
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site 10
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 44
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 01
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 30
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 21
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201-3209
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 39
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 12
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15202
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site 02
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 20
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 03
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 05
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 08
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 04
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site 15
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 49
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Site 25
City
Wien
State/Province
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Site 22
City
Sofia
ZIP/Postal Code
01431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Site 50
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Recruiting
Facility Name
Site 46
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Site 24
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Name
Site 18
City
Petach Tikva
ZIP/Postal Code
4941480
Country
Israel
Individual Site Status
Recruiting
Facility Name
Site 32
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Site 23
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Name
Site 40
City
Milan
State/Province
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site 31
City
Rome
State/Province
Roma
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site 43
City
Orbassano
State/Province
Torino
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site 34
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site 28
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site 51
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site 37
City
Rome
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site 52
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site 48
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site 47
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site 35
City
Lublin
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site 42
City
Bucharest
ZIP/Postal Code
010825
Country
Romania
Individual Site Status
Recruiting
Facility Name
Site 38
City
Bucharest
ZIP/Postal Code
011863
Country
Romania
Individual Site Status
Recruiting
Facility Name
Site 41
City
Bucharest
ZIP/Postal Code
011863
Country
Romania
Individual Site Status
Recruiting
Facility Name
Site 29
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site 14
City
Malaga
ZIP/Postal Code
29006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site 13
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site 26
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs