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Relacorilant for Endogenous Cushing Syndrome Treatment: A Safety Study

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Study Aim

This phase 2 study aims to evaluate the long-term safety of Relacorilant in individuals with Endogenous Cushing Syndrome, by monitoring the number of participants who experience treatment-emergent adverse events.

What is being tested

relacorilant

Drug
Who is being recruted

ACTH Syndrome, Ectopic+30

+ Adenocarcinoma

+ Adrenal Cortex Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2018
See protocol details

Summary

Principal SponsorCorcept Therapeutics
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 7, 2018

Actual date on which the first participant was enrolled.

This study focuses on the continued use of Relacorilant (CORT125134), a powerful and selective glucocorticoid receptor (GR) antagonist. The purpose is to treat patients who have previously participated in a study involving Relacorilant for Endogenous Cushing Syndrome, a condition where the body produces too much cortisol. The study aims to provide ongoing treatment to those who have shown improvement and could benefit from further use of Relacorilant. The importance lies in potentially offering a long-term solution for managing the signs and symptoms of this syndrome. Participants in this study will continue to take Relacorilant once daily, as long as they are benefiting from the treatment, as determined by the investigator. The dose may be adjusted based on the individual's response and tolerability. The primary outcome measured is the long-term safety of Relacorilant, specifically the number of participants who experience treatment-emergent adverse events (TEAEs). These events are assessed using a standardized system called CTCAE v4.0.

Official TitleAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
NCT03604198
Principal SponsorCorcept Therapeutics
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

125 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ACTH Syndrome, EctopicAdenocarcinomaAdrenal Cortex DiseasesAdrenal Cortex NeoplasmsAdrenal Gland DiseasesAdrenocortical HyperfunctionAdrenal Gland NeoplasmsBrain DiseasesCarcinomaCardiovascular DiseasesCentral Nervous System DiseasesCushing SyndromeDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesEndocrine Gland NeoplasmsHyperpituitarismHypertensionHypothalamic DiseasesMetabolic DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialParaneoplastic Endocrine SyndromesNervous System DiseasesNutritional and Metabolic DiseasesParaneoplastic SyndromesPituitary DiseasesVascular DiseasesAdrenocortical CarcinomaGlucose Metabolism DisordersPituitary ACTH Hypersecretion

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 48 locations

Suspended

Site 49

Phoenix, United StatesOpen Site 49 in Google Maps
Suspended

Site 35

Stanford, United States
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Site 39

Torrance, United States
Suspended

Site 50

Miami, United States
Suspended48 Study Centers