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Completed

NCT Number: NCT04308590

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

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).

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Key information

Conditions

Hypercortisolism ACTH Syndrome, Ectopic Adrenal Gland Diseases Adrenocortical Hyperfunction Cardiovascular Diseases Cushing Syndrome Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 25, Vienna, State of Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Relacorilant

Drug

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

Placebo

Other

Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline

    Time frame: Baseline and Week 22

  6. Change in HbA1c for Patients With HbA1c ≥6.5% at Baseline

    Time frame: Baseline and Week 22

  7. 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.

  8. 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.

  9. Number of Patients With Any Dose Decrease in Antihypertensive Medication

    Time frame: Baseline and Week 22

  10. Number of Patients With Any Dose Decrease in Diabetes Medication

    Time frame: Baseline and Week 22

  11. Number of Patients With Any Dose Increase or Switch in Antihypertensive Medication

    Time frame: Baseline and Week 22

  12. Number of Patients With Any Dose Increase or Switch in Diabetes Medication

    Time frame: Baseline and Week 22

  13. Number of Patients With HbA1c ≥6.5% at Baseline Who Achieved HbA1c <6.5%

    Time frame: Baseline and Week 22

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study title

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

Acronym: GRADIENT

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2020
Registry last updated
Sep 4, 2025

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.

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