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

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ClinicalTrials.gov Identifier: NCT04308590
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypercortisolism Drug: relacorilant Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 19, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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.


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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 significantly abnormal liver test results or severe renal insufficiency
  • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308590


Contacts
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Contact: Clinical Trial Lead 650 327 3270 GRADIENTstudy@corcept.com

Locations
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United States, Georgia
Site 07 Recruiting
Atlanta, Georgia, United States, 30318
United States, Louisiana
Site 09 Recruiting
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Site 11 Recruiting
Fall River, Massachusetts, United States, 02721
United States, Mississippi
Site 06 Recruiting
Jackson, Mississippi, United States, 39202
United States, New York
Site 10 Recruiting
Jamaica, New York, United States, 11432
United States, North Carolina
Site 01 Recruiting
Wilmington, North Carolina, United States, 28401
United States, Pennsylvania
Site 12 Recruiting
Pittsburgh, Pennsylvania, United States, 15202
United States, South Carolina
Site 02 Recruiting
Summerville, South Carolina, United States, 29485
United States, Texas
Site 03 Recruiting
El Paso, Texas, United States, 79935
Site 05 Recruiting
Fort Worth, Texas, United States, 76132
Site 08 Recruiting
Houston, Texas, United States, 77079
Site 04 Recruiting
Shavano Park, Texas, United States, 78231
United States, Washington
Site 15 Recruiting
Spokane, Washington, United States, 99202
Spain
Site 14 Recruiting
Malaga, Spain, 29006
Site 13 Recruiting
Sevilla, Spain, 41013
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Andreas Moraitis, MD Corcept Therapeutics
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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT04308590    
Other Study ID Numbers: CORT125134-456
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corcept Therapeutics:
Cushing syndrome
Cushing
Hypercortisolemia
Type 2 Diabetes
Impaired Glucose Intolerance
Hypertension
Adrenocorticotropic hormone
Primary Pigmented Nodular Adrenal Disease
Macronodular adrenal hyperplasia
Adrenal Adenoma
Adrenal Autonomy
Cortisol
Autonomous cortisol secretion
Additional relevant MeSH terms:
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Adenoma
Adrenocortical Adenoma
Cushing Syndrome
Adrenocortical Hyperfunction
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases