Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

April 16, 2026 updated by: Corcept Therapeutics

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.

Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Site 14
  • Canada
      • Nova Scotia, Canada
        • Site 51
  • Germany
      • Munich, Germany
        • Site 16
      • Würzburg, Germany, 97080
        • Site 42
  • Israel
      • Ramat Gan, Israel, 5265601
        • Site 20
      • Tel Aviv, Israel, 64239
        • Site 29
  • Italy
      • Ancona, Italy, 60126
        • Site 40
      • Messina, Italy, 98125
        • Site 44
      • Milan, Italy, 20145
        • Site 25
      • Naples, Italy, 80131
        • Site 21
      • Padova, Italy, 35128
        • Site 48
      • Torino, Italy
        • Site 52
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Site 33
  • Poland
      • Krakow, Poland, 30-688
        • Site 47
      • Lublin, Poland, 20412
        • Site 45
  • Romania
      • Bucharest, Romania, 11863
        • Site 28
      • Bucharest, Romania, 050474
        • Site 37
      • Bucharest, Romania, 10825
        • Site 31
  • Spain
      • Alicante, Spain
        • Site 53
      • Girona, Spain
        • Site 18
      • Madrid, Spain, 28007
        • Site 17
      • Málaga, Spain, 29006
        • Site 38
      • Seville, Spain
        • Site 19
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Site 49
    • California
      • Stanford, California, United States, 94305
        • Site 35
      • Torrance, California, United States, 90502
        • Site 39
    • Florida
      • Miami, Florida, United States, 33136
        • Site 50
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Site 10
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Site 9
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Site 1
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Site 5
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Site 27
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Site 13
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Site 8
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Site 36
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Site 34
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Site 3
    • Nevada
      • Reno, Nevada, United States, 89511
        • Site 55
    • New York
      • Albany, New York, United States, 12206
        • Site 6
      • New York, New York, United States, 10021
        • Site 24
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Site 4
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Site 43
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Site 46
      • Pittsburgh, Pennsylvania, United States, 15212
        • Site 2
    • Texas
      • Dallas, Texas, United States, 75390
        • Site 11
      • El Paso, Texas, United States, 79935
        • Site 7
      • Fort Worth, Texas, United States, 76132
        • Site 32
      • Houston, Texas, United States, 77079
        • Site 12

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Major Inclusion Criteria:

    • Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
    • According to the Investigator's opinion will benefit from continuing treatment with relacorilant

Exclusion Criteria:

  • Major Exclusion Criteria:

    • Premature discontinuation from a relacorilant parent study.
    • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
    • Has poorly controlled hypertension
    • Has Stage ≥ 4 renal failure

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: relacorilant (CORT125134)
Drug: relacorilant
CORT125134 is supplied as capsules for oral dosing.
Other Names:
  • CORT125134

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term safety of relacorilant
Time Frame: 36 months
Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0
36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term benefit of relacorilant
Time Frame: 36 months
Changes from Baseline as measured by glycated hemoglobin(HbA1c) and insulin resistance in patients with diabetes mellitus (DM) or glucose intolerance at Baseline in the parent study
36 months
Long-term benefit of relacorilant
Time Frame: 36 months
Changes from Baseline as measured by systolic and diastolic blood pressure (BP) by ambulatory BP measurements (ABPM) in patients with uncontrolled hypertension (HTN) at Baseline in the parent study and in patients with controlled HTN taking at least one anti-HTN medication.
36 months
Long-term benefit of relacorilant
Time Frame: 36 months
Changes from Baseline in weight as measured by Kg
36 months
Long-term benefit of relacorilant
Time Frame: 36 months
Changes from Baseline in waist circumference measured in cm
36 months
Long-term benefit of relacorilant
Time Frame: 36 months
Changes from Baselinein quality-of-life based on Cushing quality of life questionnaire 0 (worst) to 100 (best)
36 months
Long-term benefit of relacorilant
Time Frame: 36 months
Changes from Baseline in hypthalamic-pituitary-adrenal (HPA) axis markers (Plasma ACTH and Fasting Cortisol) and Sex steroid hormone (testosterone and estradiol)
36 months

Collaborators and Investigators

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

Sponsor

Corcept Therapeutics

Investigators

  • Study Director: Ying Ru, MD, PhD, 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)

May 7, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORT125134-452

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

product manufactured in and exported from the U.S.

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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