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

August 15, 2025 updated by: Corcept Therapeutics

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

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 (DM/IGT) and/or uncontrolled systolic hypertension (HTN).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary outcome measures of the study are 1) to assess the efficacy of relacorilant based on blood pressure control at Week 22 compared with placebo, and 2) to assess the safety of relacorilant based on adverse events. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
    • Vienna
      • Vienna, Vienna, Austria, 1090
        • Site 25
  • Bulgaria
      • Sofia, Bulgaria, 01431
        • Site 22
  • Germany
      • Würzburg, Germany, 97080
        • Site 46
    • Bavaria
      • Munich, Bavaria, Germany, 80336
        • Site 50
  • Israel
      • Ramat Gan, Israel, 5265601
        • Site 32
      • Tel Aviv, Israel
        • Site 23
  • Italy
      • Milan, Italy
        • Site 34
      • Napoli, Italy, 80131
        • Site 28
      • Padua, Italy, 35128
        • Site 51
      • Rome, Italy, 00161
        • Site 37
      • Torino, Italy, 10126
        • Site 52
    • Milano
      • Milan, Milano, Italy, 20122
        • Site 40
    • Roma
      • Rome, Roma, Italy, 00189
        • Site 31
    • Torino
      • Orbassano, Torino, Italy
        • Site 43
  • Poland
      • Gliwice, Poland, 44-102
        • Site 48
      • Krakow, Poland, 31-501
        • Site 47
      • Lublin, Poland
        • Site 35
  • Romania
      • Bucharest, Romania, 010825
        • Site 42
      • Bucharest, Romania, 011863
        • Site 38
      • Bucharest, Romania, 011863
        • Site 41
  • Spain
      • Málaga, Spain, 29006
        • Site 14
      • Seville, Spain, 41013
        • Site 13
      • Valencia, Spain, 46026
        • Site 26
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Site 27
    • California
      • Stanford, California, United States, 94305
        • Site 17
      • Torrance, California, United States, 90502
        • Site 53
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Site 07
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Site 16
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Site 09
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Site 36
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Site 11
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Site 33
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Site 06
    • Nevada
      • Reno, Nevada, United States, 89511
        • Site 54
    • New York
      • Jamaica, New York, United States, 11432
        • Site 10
      • New York, New York, United States, 10021
        • Site 44
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Site 01
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Site 30
      • Columbus, Ohio, United States, 43201-3209
        • Site 21
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Site 02
    • Texas
      • Dallas, Texas, United States, 75390
        • Site 20
      • El Paso, Texas, United States, 79935
        • Site 03
      • Fort Worth, Texas, United States, 76132
        • Site 05
      • Houston, Texas, United States, 77079
        • Site 08
    • Washington
      • Spokane, Washington, United States, 99202
        • Site 15

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Shows lack of cortisol suppression on dexamethasone suppression test
  • Suppressed or low early-morning adrenocorticotropic hormone (ACTH) levels
  • A radiologically confirmed adrenal lesion
  • Has IGT or DM
  • Has uncontrolled HTN

Exclusion Criteria:

  • Has severe, uncontrolled HTN
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Relacorilant
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
Drug: Relacorilant
Relacorilant is supplied as blister-packed capsules for oral dosing. Relacorilant 400 mg dose consists of 4 relacorilant 100-mg capsules. Relacorilant 100-mg, 200-mg, and 300-mg doses are each given as a combination of 4 capsules containing relacorilant 100-mg and placebo as per the assigned dose.
Other Names:
  • CORT125134
Other: Placebo
Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo.
Placebo Comparator: Placebo
Patients will receive placebo matched to study drug once daily.
Other: Placebo
Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Average 24-hour SBP
Time Frame: Baseline and Week 22
Blood pressure was measured by 24-hour ABPM. The 24-hour average SBP is reported.
Baseline and Week 22
Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.
Time Frame: Baseline and up to Week 26
Baseline and up to Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose)
Time Frame: Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22
AUCglucose was calculated based on results of the plasma 2-hour oGTT.
Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22
Change in Average Diastolic Blood Pressure (DBP)
Time Frame: Baseline and Week 22
Blood pressure was measured by 24-hour ABPM. Daytime average DBP was measured from 06:00 to 21:59. Nighttime average DBP was measure from 22:00 to 05:59.
Baseline and Week 22
Change in Average Heart Rate (HR)
Time Frame: Baseline and Week 22
Heart rate was measured by 24-hour ABPM. Daytime average HR was measured from 06:00 to 21:59. Nighttime average HR was measure from 22:00 to 05:59.
Baseline and Week 22
Change in Average Daytime and Nighttime SBP
Time Frame: Baseline and Week 22
Blood pressure was measured by 24-hour ABPM. Daytime average SBP was measured from 06:00 to 21:59. Nighttime average SBP was measure from 22:00 to 05:59.
Baseline and Week 22
Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline
Time Frame: Baseline and Week 22
Baseline and Week 22
Change in HbA1c for Patients With HbA1c ≥6.5% at Baseline
Time Frame: Baseline and Week 22
Baseline and Week 22
Number of Patients With DM Who Achieved 2-hour oGTT Glucose <140 mg/dL
Time Frame: 2 hours post glucose drink at Week 22
Glucose was measured using the 2 hour timepoint of the 2-hour oGTT.
2 hours post glucose drink at Week 22
Number of Patients With IGT Who Achieved 2-hour oGTT Glucose <140 mg/dL
Time Frame: 2 hours post glucose drink at Week 22
Glucose was measured using the 2 hour timepoint of the 2-hour oGTT.
2 hours post glucose drink at Week 22
Number of Patients With Any Dose Decrease in Antihypertensive Medication
Time Frame: Baseline and Week 22
Baseline and Week 22
Number of Patients With Any Dose Decrease in Diabetes Medication
Time Frame: Baseline and Week 22
Baseline and Week 22
Number of Patients With Any Dose Increase or Switch in Antihypertensive Medication
Time Frame: Baseline and Week 22
Baseline and Week 22
Number of Patients With Any Dose Increase or Switch in Diabetes Medication
Time Frame: Baseline and Week 22
Baseline and Week 22
Number of Patients With HbA1c ≥6.5% at Baseline Who Achieved HbA1c <6.5%
Time Frame: Baseline and Week 22
Baseline and Week 22
Number of Patients With Normalization of the 24-hour Average SBP (<130 mm Hg)
Time Frame: Baseline and Week 22
Blood pressure was measured by 24-hour ABPM Test. Reported is the number of patients with HTN at Baseline who achieved SBP <130 mm Hg at Week 22.
Baseline and Week 22
Number of Patients With a Reduction in 24-hour Average SBP by ≥5 mm Hg
Time Frame: Baseline and Week 22
Blood pressure was measured by 24-hour ABPM. Reported is the number of patients with HTN at Baseline who achieved at least a 5 mm Hg reduction in 24-hour average SBP at Week 22.
Baseline and Week 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corcept Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andreas Moraitis, MD, Corcept Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CORT125134-456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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