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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

Tracking Information
First Submitted Date  ICMJE February 27, 2020
First Posted Date  ICMJE March 16, 2020
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE May 19, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2020)
  • 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 ]
  • 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 ]
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2020)
  • In patients with DM at baseline the mean change in HbA1c and fasting glucose [ Time Frame: Baseline to week 22/ET ]
  • Proportion of patients with IGT at Baseline who achieved normalization of 2-hour oGTT glucose [ Time Frame: Week 22/ET ]
  • Proportion of patients with normalization of the mean SBP [ Time Frame: Baseline to week 22/ET ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypercortisolism
Intervention  ICMJE
  • Drug: relacorilant
    Relacorilant is supplied as 100 mg capsules for oral dosing.
  • Other: Placebo
    Placebo is supplied as 100 mg capsules for oral dosing.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: relacorilant
  • Placebo Comparator: Placebo
    Placebo matched to study drug
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2020)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trial Lead 650 327 3270 GRADIENTstudy@corcept.com
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04308590
Other Study ID Numbers  ICMJE CORT125134-456
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Corcept Therapeutics
Study Sponsor  ICMJE Corcept Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andreas Moraitis, MD Corcept Therapeutics
PRS Account Corcept Therapeutics
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP