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

March 5, 2024 updated by: Corcept Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • 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 Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Withdrawn
        • Site 49
    • Vienna
      • Wien, Vienna, Austria, 1090
        • Recruiting
        • Site 25
  • Bulgaria
      • Sofia, Bulgaria, 01431
        • Recruiting
        • Site 22
  • Germany
      • Wuerzburg, Germany, 97080
        • Recruiting
        • Site 46
    • Bavaria
      • Munich, Bavaria, Germany, 80336
        • Recruiting
        • Site 50
  • Israel
      • Kfar-Saba, Israel, 44281
        • Recruiting
        • Site 24
      • Petach Tikva, Israel, 4941480
        • Recruiting
        • Site 18
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Site 32
      • Tel Aviv, Israel
        • Recruiting
        • Site 23
  • Italy
      • Milan, Italy
        • Recruiting
        • Site 34
      • Napoli, Italy, 80131
        • Recruiting
        • Site 28
      • Padova, Italy, 35128
        • Recruiting
        • Site 51
      • Rome, Italy, 00161
        • Recruiting
        • Site 37
      • Torino, Italy, 10126
        • Recruiting
        • Site 52
    • Milano
      • Milan, Milano, Italy, 20122
        • Recruiting
        • Site 40
    • Roma
      • Rome, Roma, Italy, 00189
        • Recruiting
        • Site 31
    • Torino
      • Orbassano, Torino, Italy
        • Recruiting
        • Site 43
  • Poland
      • Gliwice, Poland, 44-102
        • Recruiting
        • Site 48
      • Krakow, Poland, 31-501
        • Recruiting
        • Site 47
      • Lublin, Poland
        • Recruiting
        • Site 35
  • Romania
      • Bucharest, Romania, 010825
        • Recruiting
        • Site 42
      • Bucharest, Romania, 011863
        • Recruiting
        • Site 38
      • Bucharest, Romania, 011863
        • Recruiting
        • Site 41
  • Spain
      • Girona, Spain, 17007
        • Recruiting
        • Site 29
      • Malaga, Spain, 29006
        • Recruiting
        • Site 14
      • Sevilla, Spain, 41013
        • Recruiting
        • Site 13
      • Valencia, Spain, 46026
        • Recruiting
        • Site 26
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Site 27
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Site 17
      • Torrance, California, United States, 90502
        • Recruiting
        • Site 53
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Site 55
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Site 07
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Site 16
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Site 09
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Site 36
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Recruiting
        • Site 11
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Site 45
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Site 33
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Recruiting
        • Site 06
    • Nevada
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Site 54
    • New York
      • Albany, New York, United States, 12206
        • Withdrawn
        • Site 19
      • Jamaica, New York, United States, 11432
        • Recruiting
        • Site 10
      • New York, New York, United States, 10021
        • Recruiting
        • Site 44
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Site 01
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Site 30
      • Columbus, Ohio, United States, 43201-3209
        • Recruiting
        • Site 21
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Site 39
      • Pittsburgh, Pennsylvania, United States, 15202
        • Withdrawn
        • Site 12
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Recruiting
        • Site 02
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Site 20
      • El Paso, Texas, United States, 79935
        • Recruiting
        • Site 03
      • Fort Worth, Texas, United States, 76132
        • Recruiting
        • Site 05
      • Houston, Texas, United States, 77079
        • Recruiting
        • Site 08
      • Shavano Park, Texas, United States, 78231
        • Withdrawn
        • Site 04
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • 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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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
Intervention / Treatment
Experimental: Relacorilant
The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily.
Drug: relacorilant
Relacorilant is supplied as 100 mg capsules for oral dosing.
Placebo Comparator: Placebo
Placebo matched to study drug
Other: Placebo
Placebo is supplied as 100 mg capsules for oral dosing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to week 22
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
Baseline to week 22
Rate of safety based TEAEs
Time Frame: Baseline to week 22
Assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0.
Baseline to week 22

Secondary Outcome Measures

Outcome Measure
Time Frame
In patients with DM at baseline the mean change in HbA1c and fasting glucose
Time Frame: Baseline to week 22/ET
Baseline to week 22/ET
Proportion of patients with IGT at Baseline who achieved normalization of 2-hour oGTT glucose
Time Frame: Week 22/ET
Week 22/ET
Proportion of patients with normalization of the mean SBP
Time Frame: Baseline to week 22/ET
Baseline to week 22/ET

Collaborators and Investigators

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

Sponsor

Corcept Therapeutics

Investigators

  • 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)

July 27, 2020

Primary Completion (Estimated)

March 29, 2024

Study Completion (Estimated)

March 29, 2024

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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