Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03604198

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Cushing Syndrome ACTH Syndrome, Ectopic Adenocarcinoma Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenocortical Carcinoma Adrenocortical Hyperfunction Brain Diseases Carcinoma Cardiovascular Diseases Central Nervous System Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine Gland Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Hyperpituitarism Hypertension Hypothalamic Diseases Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Nutritional and Metabolic Diseases Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Pituitary ACTH Hypersecretion Pituitary Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 14, Vienna, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relacorilant

Drug

CORT125134 is supplied as capsules for oral dosing.

Other names: CORT125134

Primary outcomes

  1. Long-term safety of relacorilant

    Time frame: 36 months

    Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0

Other outcomes

  1. 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

  2. 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.

  3. Long-term benefit of relacorilant

    Time frame: 36 months

    Changes from Baseline in weight as measured by Kg

  4. Long-term benefit of relacorilant

    Time frame: 36 months

    Changes from Baseline in waist circumference measured in cm

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2018
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.